Job Responsibilities:

- Follows current work instruction and insures adherence to the Quality Control Plan and related SOP's.
- Performs SPC Control Charting and takes appropriate corrective action.
- Follows all applicable waste, scrap reduction and recycling guidelines.
- Achieves required OEE levels on assigned Packaging Line(s).
- Performs, practices good Housekeeping.
- Consistently demonstrates leadership abilities on designated lines that he/she is operating.
- Trains and certifies new Technicians, Operators, and Temps as needed.
- Works effectively in a Team based work environment.
- Able to send and receive E-Mail in a timely and effective manner.
- Performs other duties as assigned by management.

Job Qualifications:

- Experience operating packaging line equipment like Can Depalletizers, Sorters/Orienters, Filler/Capper, Valve Inserters, Labelers, Sleevers, Heat Shrink Wrap Tunnels, Case Formers, Case Packers, Conveyors, Palletizers, Unitizers, Gasser, Crimper, Thermoform, Blister Machine, etc.
- Experience operating packaging line and related equipment from startup, through all manual adjustments (like clearing jams), to shutdown.
- Experience troubleshooting packaging line equipment problems to determine root cause and making effective repairs and adjustments in a timely manner.
- Experience performing scheduled Preventative Maintenance (PMs) to insure equipment efficiency.
- Demonstrated ability to set up and change over all Packaging Line equipment in a timely manner to insure minimum down time and smooth start up.
- Experience using computers for data entry and reporting purposes.
- Must have strong communication skills and command of English, both verbal and written.
- For future promotional opportunities, mechanical and/or electrical experience operating maintenance equipment like the lathe, drill press, welding equipment, power and hand tools, pipe threader, hydraulic press, band saw, table saw, etc. and appropriate measurement tools like micrometers, scales, gauges, PC for CCMail, on-line SPC, etc.

Discover all that's possible with Yoh. Apply now.

Yoh is a professional staffing provider with over 70 years of experience in the short and long-term staffing services industry; visit our website to learn more about our company. If you are seeking workforce solutions in the IT sector, see our comprehensive IT Staffing Resources.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

J2W: ENG

Ref: 1018554

SFSF: LS

Job Responsibilities:

- Contribute to R&D, LCM and Industrial Development and Innovation projects (in-licensing, partnership projects) by planning, writing and delivering agreed submission deliverables for US, EU and rest of world (ROW) registrations for multiple dosage forms.
- Author and create dossier content from source documentation as needed for registrations and provide writing support for technical reports.
- Recommend table of contents for regulatory submissions.
- Develop and contribute to regulatory strategy for successful product registration.
- Provide and write answers to questions received from regulatory authorities.
- Create and author dossiers for re-registrations.
- Ensure all dossiers are in compliance with appropriate SOPs, guidance's, GXP and ICH guidance's and maintain up to date knowledge.
- Communicate with Quality and manufacturing site teams to request necessary content and documentation for regulatory submissions.
- Develop and maintain skills required for dossier related software systems used and included in regulatory filings.

Job Qualifications:

- BS / BA or MS in Biology, Analytical Chemistry or a related field with four to six (4 - 6) years of experience in the Bio-Pharmaceutical industry.
- Technical writing and communication skills with strong background in pharmaceutical manufacturing, regulatory writing or quality control / quality assurance with at least four (4) years of experience in pharmaceutical manufacturing or development, obtained by working in a cross-functional team-oriented environment in the bio or pharmaceutical industry.
- Working knowledge of cGMP's.
- Demonstrated ability to interact with a multi-disciplined team.
- Experience working with writing template tools, Documentum.

Discover all that's possible with Yoh. Apply now.

Recruiter: Sondra Davis

Yoh is a professional staffing provider with over 70 years of experience in the short and long-term staffing services industry; visit our website to learn more about our company. If you are seeking workforce solutions in the IT sector, see our comprehensive IT Staffing Resources.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

J2W: CLINCIAL; J2W: SCIENTIFIC

MONJOB

Ref: 1020052

SFSF: LS

Job Responsibilities:

- Responsible for the information management and technology needs of Pharma Development.
- Responsible for application life cycle management of existing applications and executing projects sponsored by the business line functions.
- Serve as Application Manager, supporting IT projects and maintenance activities for the Modeling and Simulation (M&S) Global Line Function.
- Support for all MODESIM users (not only limited to M&S) needs to be provided.
- Collect new user requirements, plan and implement application changes by involving all relevant parties (e.g. IT, QA, Business).
- Day to day support of the MODESIM platform.
- Responsible for End user support.
- Analyze Service Requirements in business to define/revise service levels.
- Monitor Service Quality and put proactive measures in place to improve it.
- Plan, budget and resource all initiatives requested by the business area for a particular application(s).
- Project oversight and reporting for requested project and tasks.
- Implement application enhancements and modifications as necessary to meet business needs.

Job Qualifications:

- A university degree BS / BA in Computer Science or related discipline with an advanced degree MS and 10+ years of diverse professional experience encompassing business consulting, preferably in clinical drug development.
- Business process knowledge in drug development.
- Understanding of GxP environments and health authority requirements for computer systems validation.
- Knowledge of the following:


- Job Scheduling / Queuing systems (e.g. SGE, LSF, PBS), Linux application and software installation Scripting and programming experience required (eg. Shell, Perl).
- ClearCase and Subversion usage an benefit.
- LAMP (Linux, Apache, MySQL, PHP) highly desired.
- Java web applications (Tomcat, JBOSS) , VMware ESX management.

Discover all that's possible with Yoh. Apply now.

Recruiter: Chad DiLella

Yoh is a professional staffing provider with over 70 years of experience in the short- and long-term staffing services industry; visit our website to learn both about our company and about our leading workforce solutions.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

J2W: INFOTECH

Tax Term: CON_W2

MONJOB

Ref: 1020865

Enterprise: IT & Telecom

Job Responsibilities:

- Manage major construction projects at multiple North American sites.
- Responsibilities include developing design concepts with the users and design engineering firm, developing request for proposals to bid projects, coordination with customers, contractors and consultants, review documents, prepare capital appropriation requests, review and pay invoices, monitor progress, quality control , assist with safety issues and training, and proper project closure
- Ability to handle multiple projects with no supervision
- Provide high level support to Corporate Services as well as other departments
- Value Engineer as needed
- Make key decisions and recommendations to management
- Coach/Mentor other Facilities Engineers, levels I and II
- Maintain an awareness of all state, local, and company policies and regulations relating to safety, security and environmental protection.
- Coordinate the completion of commissioning and qualification documentation
- Determine if high impact decisions require supervisor approval
- identify problems and provide solutions
- Team leader
- Ability to delegate tasks and responsibilities

Job Qualifications:

- Bachelor of Science degree in Engineering or a closely related field or equivalent work experience
- Minimum ten (10) years experience in a manufacturing, pharmaceutical, biotech or construction environment or equivalent.
- Work effectively in a team environment and interface closely with Corporate Services as well as other departments
- Skilled in PC usage and associated software including Microsoft Office
- Must have GXP experience
- Primavera scheduling software
- Oracle project finance software
- Good organizational skills

Discover all that's possible with Yoh. Apply now.

Yoh is a professional staffing provider with over 70 years of experience in the short and long-term staffing services industry; visit our website to learn more about our company. If you are seeking workforce solutions in the IT sector, see our comprehensive IT Staffing Resources.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

J2W: CLINICAL; J2W: ENG

MONJOB

Ref: 1020585

SFSF: ENG

Job Responsibilities:

- Development, qualification, and implementation of analytical methods for protein therapeutics.


- Design and implementation of experiments to investigate protein product quality attributes
- Prepare all lab document/protocols.
- Focus on established and new art science and technology to meet project
needs for analytical sciences.
- Work closely and support Bioassay, QC and Process Development on scientific issues.
- Support publication and patenting of scientific work.


- Analytical Characterization of protein therapeutics


- Design and execution of experiments to delve into product-related substances and impurities and their biological relevance.
- Characterization of product and process-related impurities in Process Development / i-process samples.
- Design and execution of multi-arm stability studies to assess biologics degradation pathways.
- Execution of comparability studies.


- Culture


- Support business development activities as required.
- Support solutions for innovation and collaboration.
- Develop customer relationships with peers.

Job Qualifications:

- B.S. in Biochemistry / Biotechnology or related field.
- Minimum of one (1) year relevant experience in analytical sciences of protein Biotherapeutics (mAbs, antibody fusion proteins, and other protein constructs).
- Hands on experience with HPLC of proteins using multiple modes of separation (SE-HPLC, IEX-HPLC, RP-HPLC), peptide and glycan mapping, UPLC, CE (rCE-SDS and cIEF, LIF detection), SDS-PAGE and UV & Fluorescence spectroscopy.
- Motivation to be part of a high performance, efficient scientific team.
- Excellent spoken and written communication skills.

Preferred Job Skills / Experience / Knowledge:

- MS experience is a plus.
- ELISA experience is a plus.
- Experience with cGMP regulations is preferred.

Discover all that's possible with Yoh. Apply now.

Recruiter: Sidra Javed

Yoh is a professional staffing provider with over 70 years of experience in the short- and long-term staffing services industry; visit our website to learn both about our company and about our leading HR Solutions.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

J2W: CLINICAL; J2W: SCIENTIFIC

MONJOB

Ref: 1015066

SFSF: LS

Job Responsibilities:

- Development, qualification, and implementation of biological characterization methods for protein therapeutics.
- Design and implementation of experiments to investigate protein product quality attributes
- Prepare all lab document / protocols.
- Focus on established and new art science and technology to meet project.
- Needs for analytical sciences.
- Work closely and support Bioassay, QC and Process Development on scientific issues.
- Support publication and patenting of scientific work.
- Analytical Characterization of protein therapeutics.
- Design and execution of experiments to delve into product-related substances and impurities and their biological relevance.
- Characterization of product and process-related impurities in Process Development / i-process samples.
- Design and execution of multi-arm stability studies to assess biologics degradation pathways
- Execution of comparability studies.

Job Qualifications:

- BS / MS in Biochemistry / Biotechnology, Cell Biology, Immunology or related field
- Minimum of three (3) years of pharma / biotech industrial experience in functional biochemical / cell-based assay, potency assay.
- Strong working knowledge of GMP regulations. Experience with the use of ELNs in a compliant environment a plus.
- Proven track record supporting biologics drug development.
- Solid experience with functional and potency assay development, validation, and tech transfer.
- Strong scientific understanding and experience with ELISA, flow cytometry, Biacore / surface plasmon resonance, cell signal transduction, reporter constructs, molecular biology, FACS, and mammalian cell culture. Experience with comparability studies and regulatory filings is preferred.

Discover all that's possible with Yoh. Apply now.

Recruiter: Lindsay Lee Morgan

Yoh is a professional staffing provider with over 70 years of experience in the short- and long-term staffing services industry; visit our website to learn both about our company and about our leading HR Solutions.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

J2W: SCIENTIFIC; J2W: CLINICAL

Ref: 1021101

SFSF: LS

Job Responsibilities:

- Responsible for glycosylation characterization, antibody/protein primary structure characterization, Post Translational Modifications characterization to assist the Analytical group, Formulation group, Discovery group, and bio-process department for a range of therapeutic proteins, including monoclonal antibodies and novel protein formats.
- Perform characterization of antibody/protein using UPLC, UPLC-MS based techniques.
- Develop, utilize, and troubleshoot HPLC, HPLC / MS assays, qualification of assays, transfer assays to Analytical / quality labs, documentation, collection and purification of variants.
- Maintain accurate / on-time laboratory notebooks and relevant documentation.

Job Qualifications:

- A BS / MS degree with a minimum of three (3) years hands-on industry experience in antibody / protein analyses with various liquid chromatography, liquid chromatography-mass spectrometry methods and protein purification techniques.
- Seeking an innovative and motivated hands-on working professional who exhibits a broad analytical aptitude and can function in a highly collaborative multidisciplinary team environment.
- A strong working knowledge and experience with common modes of chromatographic separation such as hydrophobic / hydrophilic interaction chromatography, reversed-phase, ion-exchange, affinity and size exclusion.
- Hands on experience on sample preparation for N-glycosylation, peptide mapping and etc.
- A basic understanding of protein chemistry, Post Translational Modifications and degradation pathways.
- Familiar to software Empower, Xcalibur, MassLynx for data acquisition and data processing, and data reporting.
- Familiarity and exposure to FDA, ICH and GLP, GMP regulations and guidelines.

Preferred Job Skills / Certifications / Knowledge:

- Experience with UV-Vis spectroscopy, fluorescence spectroscopy, light scattering, calorimetry, particle size, DSC, DLS, MALS, TFF, electrophoresis (CE, IEF, SDS-PAGE, Western blot) and similar techniques for Secondary and Higher Order Structural Characterization.

Discover all that's possible with Yoh. Apply now.

Recruiter: Sidra Javed

Yoh is a professional staffing provider with over 70 years of experience in the short and long-term staffing services industry; visit our website to learn more about our company. If you are seeking workforce solutions in the IT sector, see our comprehensive IT Staffing Resources.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

J2W: SCIENTIFIC; J2W: CLINICAL

Ref: 1018485

SFSF: PROF

Job Responsibilities:

- Support the development of operational plans for clinical deliverables, effectively applying principles of design excellence.
- Contribute to the development and review of Clinical Development Plan (CDP) with focus on operational aspects including other develop program level plans to support project level allocation, outsourcing strategy, and monitoring committees that may require Board review.
- Support the development of the Operational CDP (O-CDP).
- Create trial concept sheet.
- Responsible to lead operational excellence in the CSU and scientifically supports CSU by ensuring development of program quality standards (e.g. collation of synopsis / protocols / CDP reviews, provide scientific / medical input, advisory boards, education activities).
- Support development and implementation of disease / program standards within CSU.
- Support Medical Lead with the development of program level documents, including clinical sections of regulatory documents (e.g. Investigators' Brochures, briefing books, submission dossier, and responses to Health Authorities questions).
- Responsible for execution of assigned clinical deliverables within approved budget.
- Manage several trials in parallel with multidisciplinary trial teams in a matrix organization.

Job Qualifications:

- Advanced degree (or clinically relevant degree) in life sciences / healthcare is required.
- Pharm.D, PhD preferable.
- Four (4) years of technical and operational experience in planning, executing, reporting and publishing clinical studies in a pharmaceutical company or contract research organization.
- Thorough knowledge of Good Clinical Practice, clinical trial design, statistics, regulatory processes, and clinical development process.
- Knowledge of the assigned therapy area is desired.
- Demonstrates knowledge and application of statistical analysis methodology and can identify trends and interpret / report data effectively.

Discover all that's possible with Yoh. Apply now.

Recruiter: Zachary Stewart

Yoh is a professional staffing provider with over 70 years of experience in the short- and long-term staffing services industry; visit our website to learn both about our company and about our leading HR Solutions.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

J2W: SCIENTIFIC; J2W: CLINICAL

MONJOB

Ref: 1021349

SFSF: LS

Job Overview:

As the Online Marketing Specialist, you will interface with clients, establish and implement the firm's online marketing methodologies and provide regular reporting. You will be responsible for understanding a client's business objectives, creating their online marketing strategy (including organic SEO, link building, PPC, social media, etc.) delivering measurable results and quality analysis to clients on a monthly basis. You will be required to demonstrate cutting-edge knowledge of online marketing techniques in communication with clients and stakeholders, both in existing client relationships and in new business development situations. The position will report directly to the Director of Interactive and Production.

Features:

- Unique Role: Responsible for leading and directing the search marketing strategies of the firm, and its many clients. This position will be an integral part of the company and one of the key people from an online marketing perspective for new and existing clients.
- Growth Potential: There is a tremendous amount of growth potential in this role as you will be leading the firm's evolving digital marketing strategies and initiatives, and responsible for helping to grow this key component of the firm's services and revenue.
- Continuous Learning: Firm encourages and sponsors continuing education opportunities.
- Client Interaction: This position regularly interfaces directly with clients and potential clients.

Job Responsibilities:

- Digital Communications Creation and Deployment - including blog creation, social media management, and managing email marketing deployments.
- Website Analysis, Reporting and Recommendations.
- Keyword Analysis, Reporting and Recommendations.
- Competitive site analysis and recommendations.
- Conversion optimization strategies.
- Client Training, when necessary.
- Usability and quality assurance (such as cross-platform testing).
- E-mail Marketing testing, deployment, monitoring and analysis.
- Social media management and content deployment.

Job Qualifications:

- Search Engine Optimization tactics.
- Search Engine Marketing tactics.
- Competitive intelligence gathering.
- Link building strategies.
- Google / Microsoft advertising PPC administration.
- Social media strategies.
- Content administration.
- E-mail Marketing.

Discover all that's possible with Yoh. Apply now.

Recruiter: Lori Sklarski

Phone Number: 201-630-2001

Yoh is a professional staffing provider with over 70 years of experience in the short- and long-term staffing services industry; visit our website to learn both about our company and about our leading HR Solutions.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

J2W: PROF; J2W: MEDIA

Ref: 1020940

Branch: IT & Telecom

Job Overview:

Windows 7 Migration Specialist will coordinate all activities related to finalizing the selection, packaging and unit testing of standard desktop software applications for American Water lines of business in preparation for their migration to Windows 7.

Job Responsibilities:

- Create line of business application profiles by department and user.
- Work with business directly to analyze software applications and determine which versions should become standards, can be replaced by native Windows 7 functionality or can be retired.
- Work with project team to prioritize the packaging and testing of applications.
- Identify Technical SMEs for standardized applications and facilitate application packaging and unit testing with Application Packager.
- Identify User Acceptance Testers and work with QA Analyst to monitor testing status.
- Conduct application research if required to assist with troubleshooting issues during application packaging, testing and implementation.
- Provide statistics to project management on status of standardization by line of business.
- Analyze existing licensing data and processes to identify opportunities for consolidation and assure proper licensing coverage in conjunction with deployment of applications through the Windows 7 migration.

Job Qualifications:

- Two to three (2 - 3) years' application analysis / standardization experience; five to seven (5 - 7) years overall IT experience preferred.
- Technical or Associate's Degree required, Bachelor's degree is desired.
- Must have prior experience with desktop software application analysis and standardization.
- Must have prior experience working directly with business users and business management.
- Must understand a standard packaging process and workflow.
- Must have knowledge of desktop deployments for Windows platforms.
- Must have ability to work on-site in a secure customer environment.
- Must have political awareness and sensitivity in customer situations.
- Must be able to work independently and as a team member.
- Must be able to troubleshoot problems.
- Must be able to meet deadlines.
- Willingness to be able to work after hours and some weekends if required.
- Must be able to produce status reports and statistics.

Discover all that's possible with Yoh. Apply now.

Yoh is a professional staffing provider with over 70 years of experience in the short- and long-term staffing services industry; visit our website to learn both about our company and about our leading HR Solutions.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

J2W: INFOTECH

Tax Term: CON_W2

MONJOB

Ref: 1019636

Enterprise: IT & Telecom

Job Responsibilities:

- Leading one or several cross functional study teams (and/or sub-teams) to deliver clinical research studies on time, within budget and with good quality in compliance with Regulatory Authorities regulations/guidelines and SOPs/WPs.
- Sharing best practices - Contributing to process improvement initiatives
- Study Team Leadership - Lead cross-functional study team and/or sub-team, develop, manage and maintain study timelines, minutes, budget and tracking, develop training materials and coordinate training on study procedures, develop study management plan - study specific working practices, develop, manage, and maintain relationships with affiliate offices, develop study execution plans
- Study Planning - Review and comment on study documents such as synopsis, protocol, ICF and CRFs, develop overall study budgets, recommend number of investigative sites, oversee the development of investigational product supply forecasting and management, input on project specifications and feedback on requirements for CTMS, guide structure and oversee set up TMF
- Selection and Evaluation of Investigative Sites - Participate in country selection, in collaboration with CRP and CRS, identify prospective investigative sites, review feasibility, participate in final investigative sites selection, develop and monitor investigative site budgets and oversee negotiation of financial terms of individual site budgets, manage site payments, monitor GCP/ICH site level compliance
- Identification and Selection of Vendors - Participate in preparation of RFP, assumptions and SOW, recommend vendors, contribute and review specs for vendors (IVRS, Labs), management of vendor oversight, review and approve vendor invoices
- Preparation of Study Documentation - Review essential regulatory documents, prepare detailed study timeline, develop and oversee risk management plan (e.g. for poor enrollment), prepare, review and approve Monitoring Plan, assure adherence to Monitoring Plan, review eCRF specs (EDC) and review of CRF completion guidelines, design, review and approve study tools (for investigative site use), create study team contact roles and responsibilities, review DM documents (CRO and in-house studies), facilitate Development and Review of Data Review Plan
- Input Clinical Database, Safety and CSR Reports - Review edit specifications (paper and EDC), execute EDC User Acceptance Testing (UAT) scripts, facilitate development and review of Clinical Data Review Plan, review Summary Reports, CSR review - appendices and approval, oversight of safety report distribution to investigators, study team and ECs as applicable. Participate in SAE reconciliation.
- Initiation and Site Start Up - Prepare and review material for investigator meeting and CRA Training, conduct CRA training, plan / organize / conduct Investigator meeting, oversight of country regulatory approvals (e.g. CTA, MoH), oversee country / site IRB / EC approval, , oversee and/or prepare, review regulatory package (essential documents - blank forms and templates for 1572s, financial disclosure, etc.), review regulatory packages, develop and coordinate materials for investigator meeting, obtain appropriate country/site insurance, authorize investigational product shipment to investigational sites, including (in association with Regulatory) the initial shipment, review and approve informed consent forms (e.g. site or country specific ICFs)
- Enrollment and Maintenance of Subjects - Ensure enrollment is tracked and recorded appropriately, compile enrollment status, update recruitment strategy, address enrollment and retention issues
- Follow-Up of Sites, Subjects and Data - Oversight of clinical monitoring to ensure quality data (sourced or out-sourced), oversee review and approval of monitoring trip reports, review data as defined by Study Team, schedule and conduct CRA meetings / teleconferences, follow up on outstanding CRFs and DCFs, perform ongoing resolution of subject eligibility, oversee resolution of study conduct issues, address site issues found during audits, support DMC reviews, ensure TMF is current
- Close Out - Coordinate study close out, coordinate case book preparation, reconcile payments, reconcile study budget, complete all archiving, reconcile TMF
- Line Management -May be responsible for overall performance management of direct reports, including:


- Oversee personnel and assure adherence to GCP/ ICH and SOPs/WPs
- Lead the performance review process for direct reports.
- Identify and address performance issues and training needs.
- Provide guidance regarding company policies and procedures.

Job Qualifications:

- Disease / therapeutic knowledge
- Excellent oral / written / presentation - solid communications skills
- Knowledge of ICH/GCP and regulatory guidelines/directives
- Leadership skills (get it done) / negotiation skills
- Mentoring / coaching
- Time management - ability to effectively multi-task and prioritize
- Financial budgeting and forecasting skills
- Project management / organizational skills
- Solid computer skills - requirement of MS applications including (but not limited to) MS Project, Word, Excel
- Study Tools including electronic system skills - CTMS / EDC
- Knowledge of drug development process
- Cross functional and cross-cultural awareness
- Ability to work in a matrix environment

Discover all that's possible with Yoh. Apply now.

Recruiter: Lindsay Lee Morgan

Yoh is a professional staffing provider with over 70 years of experience in the short and long-term staffing services industry; visit our website to learn more about our company. If you are seeking workforce solutions in the IT sector, see our comprehensive IT Staffing Resources.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

J2W: CLINICAL

MONJOB

Ref: 1020639

SFSF: LS

Job Responsibilities:

- Proactively support the Vitamins, Minerals and Supplements Category and R&D teams, providing Nutritional & Medical input to build a successful strategy for global role out:
- Implementation of Medical / claims work associated with specified projects, meeting required milestones
- Understand the global landscape with respect to regulatory environment to help develop dossier for global registrations
- Generate strong external network and proactively liaise with key opinion leaders to gain project input, build greater insights and expertise in category specific indications and to enhance the Company's knowledge base
- Ability to analyze clinical data and provide point of view quickly.
- Network in the science field and spot opportunities in trade shows
- Ensure all products and ingredients have appropriate, high quality and thorough Medical (safety and efficacy) assessments and that these meet internal, legal and regulatory requirements
- Provide medical information and advice in the development of project concepts and related claims, ensuring that claims are medically accurate, fair, balanced and defendable
- Contribute to production of scientific information required for the development of position papers and responses to press release
- Keep up-to-date with product literature and current medical opinion, alerting the project teams to new clinical data or medical press coverage that may impact upon the successful completion of a project
- Advise upon the best medical approach to build upon positive data or to counteract adverse publicity
- Contribute to Medical and Innovation strategy for the brand and to implement Medical strategy for all key initiatives within area of responsibility
- Contribute to budget development as required

Job Qualifications:

- Graduate degree in a relevant scientific discipline (e.g. Nutrition, Pharmacy, Medicine)
- Strong track record in industry generating new products, innovations and scientific/consumer insights
- Direct Medical expertise within VMS Category strongly preferred, including high level knowledge of ingredients used in the dietary supplement industry
- Ability to priorities effectively, work under pressure and meet deadlines
- Excellent communication skills, including taking complex scientific topics to non-scientific audiences.
- Effective and demonstrated medical and scientific writing skills, including safety and efficacy assessments, claims support packages and articles
- Strong external network within the dietary supplement industry, including suppliers and KOLs - ability to influence externally
- Ability to effectively assess and critique medical and scientific information to very high standard
- Good understanding of the clinical trial process and requirements
- Creative, and entrepreneurial, but also results-oriented, self-motivated, with solid planning and organizational capabilities and a bias for action
- Strong intellectual curiosity with an appetite for exploring new and previously uncharted territories and an openness to change and ability to think out of the box
- Global mind-set, ability to think across functional boundaries and to develop a commercial understanding of corporate and operational business issues

Preferred Job Skills / Experience / Knowledge:

- Global experience is preferred

Discover all that's possible with Yoh. Apply now.

Recruiter: Sidra Javed

Yoh is a professional staffing provider with over 70 years of experience in the short- and long-term staffing services industry; visit our website to learn both about our company and about our leading HR Solutions.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

J2W: CLINICAL

Ref: 1021167

SFSF: LS

Job Overview:

- Under general supervision, provides Tier I software and hardware support.
- Applies department procedures to diagnose and resolve problems.
- Maintains call data tracking system.
- Escalates problems to higher level technical support professionals when necessary.
- Provides support to Client Support team including call assistance and information sharing.
- Applies and enforces ITS policies and procedures including, but not limited to, incident management, problem management, project management methodology, and SOX controls.
- Applies and enforces Service Support procedures for the Service Desk including, but not limited to, call handling, documentation, escalation, and providing support.
- Ensures individual performance achieves defined service level targets
- Contributes toward continuous process improvement of internal ITS processes in order to meet changing business unit conditions.
- Responds to incidents or requests immediately
- Assumes ownership of each incident or request until it is resolved and ensures client's satisfaction
- Thoroughly documents all incidents or requests.
- Responsible for resolving incidents through the application of recorded solutions or through Incident recognition, research, isolation, resolution, escalation and follow-up.
- Interacts with clients in a courteous and professional manner.
- Tracks all client contacts
- Researches questions and issues; resolves each interaction to client's satisfaction.
- Provides updates, status, and completion information to the service management tool, and/or to users, via voice mail, e-mail, telephone, or in-person communication.
- Become well versed with common problem inquiries and be able to provide immediate solutions.
- Escalate problems to second or third level support personnel when appropriate via proper escalation procedures.
- Identifies frequently occurring problems and establishes procedures which document work and/or solutions.
- Provides on-call client support outside normal business hours.
- Provide support to projects
- Prepare in advance for new releases and rollouts to anticipate customer inquiries.
- Regularly attend technical and communication training sessions.
- Regularly handles high volumes of sensitive/confidential information
- Other task assigned by Manager ?????

Job Qualifications:

- Excellent written and verbal communication skills along with the ability to absorb and present large amounts of detail through various forms of communications to any level of business users, IT management, or technical role.
- Experience working with Lotus Notes a plus.
- Excellent client relations skills and customer service orientation.
- Excellent planning, prioritizing, time management and organization skills.
- Able to work on a team and contribute to the team's achievement of objectives and goals
- Demonstrated analytical, problem solving, planning, critical thinking, and risk assessment skills.
- Demonstrated ability to absorb and present large amounts of detail through various forms of communications.
- Demonstrated ability to meet stringent deadlines
- Thorough knowledge of Microsoft Office products, e.g., word processing, spreadsheet, presentation, data base, project planning.
- Knowledge of ITIL processes and procedures.
- Knowledge of common industry Service Management Tools HP Openview or BMC Remedy
- Typically has 3-5 years of IT work experience with demonstrated working knowledge of basic to moderately complex hardware and software products and problem solving/troubleshooting skills.
- Experience working effectively as a team member with supervision on projects to ensure the high quality of the delivered software.
- Experience with the utility industry is desirable, but not required.

Discover all that's possible with Yoh. Apply now.

Yoh is a professional staffing provider with over 70 years of experience in the short- and long-term staffing services industry; visit our website to learn both about our company and about our leading HR Solutions.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

Tax Term: CON_W2

J2W: INFOTECH

MONJOB

Ref: 1021113

Enterprise: IT & Telecom

Job Responsibilities:

- Execute written procedures for performing manual visual inspection of empty vials, diluents, and drug product with a focus on quality and efficiency.
- Adhere to all plant safety policies and procedures and proactively identify unsafe conditions.
- Assist in set up, change over, and test run equipment for various-sized vials and packages as required.
- Support the Operations Specialist, Maintenance, and/or outside services in the repair, maintenance, and calibration of GNE systems as required.
- Perform training of other Technicians.
- Assist in the development of plant SOP's and training materials.
- Execute production recipes, check-in equipment, and perform material movements using automated computer software applications (SAP and MES systems).
- Operate all formulation, sterile filling, inspection, and final vial packaging equipment in the plant.
- Perform material handling in the plant as required.
- Perform preparation of sterile components.
- Assist in the cleaning, set-up, sterilization, and disassembly on a variety of processing equipment.
- Perform bulk thaw, dilution, and formulation operations.
- Perform manual inspection of empty vials and filled product with a focus on quality and efficiency.
- Conduct environmental monitoring activities in the manufacturing areas as required.
- Perform all documentation and clerical functions to provide the proper accountability and traceability of components and finished product.

Job Qualifications:

- One to two (1 to 2) years of (within the last seven (7) years) experience in the operation of complex mechanical equipment used in the washing, filling, conveying, sealing, inspection and packaging of products / containers is highly desirable.
- Target industries include pharmaceutical, biotechnology, biomedical, electronic, chemical, food, cosmetics, and/or other medical industries.
- High school diploma or equivalent AND Graduate of a two-year Associates Degree program in Electrical / Mechanical Technology (or equivalent) is a plus.

Discover all that's possible with Yoh. Apply now.

Recruiter: Hannah Cihlar

Yoh is a professional staffing provider with over 70 years of experience in the short- and long-term staffing services industry; visit our website to learn both about our company and about our leading professional staffing solutions.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

J2W: SCIENTIFIC; J2W: CLINICAL

MONJOB

Ref: 1021150

SFSF: LS

Job Responsibilities:

- Assist with the oversight of a Category or Categories of GMP raw materials and suppliers to make certain that quality raw materials are provided
- Issue supplier corrective action requests
- Follow through with corrective and preventive actions
- Assist with root cause analysis in relation to supplier-related non-conformances
- Assist with supplier quality agreements
- Oversee audits
- Evaluate supplier change notifications
- Create or revise raw material specifications
- Assist with operational excellence / process improvement initiatives / projects

Job Qualifications:

- B.S. degree with three (3) plus years of quality assurance experience in the pharmaceutical industry.
- Must have GMP and SOP experience.
- Experience with drafting, developing, and finalizing new standard operating procedures
- Advanced knowledge of quality systems and the ability to interpret and perform comprehensive assessment of quality systems

Discover all that's possible with Yoh. Apply now.

Recruiter: Salima Hakim

Yoh is a professional staffing provider with over 70 years of experience in the short- and long-term staffing services industry; visit our website to learn both about our company and about our leading HR Solutions.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

J2W: CLINICAL

MONJOB

Ref: 1021556

SFSF: LS

Job Overview:

Responsible for assisting in preparation, implementation, conformance and verification of Company quality policies and Regulatory Affairs procedures in compliance with 21 CFR Part 820 Quality System Regulations, ISO 9000 series standards and applicable International standards.

Job Responsibilities:

- Develop, maintain and monitor programs for compliance with the Quality Systems Regulations and internal procedures.
- Update QS electronic files with relevant data for new products / materials and perform maintenance to existing items.
- Participate in general review and update of Standard Operating Procedures according to Food & Drug Administration Quality System Regulations, ISO 13485, and internal procedures.
- Assists in reviewing and revising the Device Master Record and Standards Operating Procedures.
- Maintains Document Change Control records.
- Maintains employee training records and performs training as necessary.
- CAPA (Corrective and Preventative Action) facilitation and management.
- Customer complaint handling.
- Reviews and reconciles production records, equipment validation and monitoring records, and all QA monitoring records.
- Monitors and develops charts regarding customer complaints on a monthly basis.
- Monitors material discards on failed production lots.
- Investigates and files documentation regarding Nonconforming materials.
- Calibrates and maintains records of various instruments.
- Reviews new equipment design and validation data.
- Maintains vendor files, qualifies new vendors and conducts vendor audits when necessary.
- Ensures maintenance work orders are completed and PM of equipment is maintained.
- Schedules waste pickup.

Job Qualifications:

- BA in Bio Science or Chemistry.
- Experience with ISO9000 and ISO13485.
- Experience with FDA regulations.
- Medical device manufacturing regulatory.
- Microsoft Office / Excel.

Discover all that's possible with Yoh. Apply now.

Yoh is a professional staffing provider with over 70 years of experience in the short- and long-term staffing services industry; visit our website to learn both about our company and about our leading HR Solutions.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

J2W: SCIENTIFIC; J2W: CLINICAL

Ref: 1020177

Branch: IT & Telecom

Job Responsibilities:

- Revise the written content of Batch Production Records and SOP's to be used by manufacturing associates.
- Create new or revise existing content for SOPs and BPDs with a high degree of quality in accordance with cGMP requirements and corporate guidelines.
- Work collaboratively with project team members including Manufacturing, Engineering, Process Development, Quality and other subject-matter experts to solidify content.
- Participate in project team meetings.

Job Qualifications:

- Bachelor Degree in Science preferred.
- Experience in a Quality Control environment; knowledge of GMP and/or ISO standards.
- Experience in biotech and/or pharmaceutical manufacturing environment an asset.
- Minimum two (2) to five (5) years related experience in technical writing.
- Detail oriented with the ability to learn new concepts and apply them quickly.

Discover all that's possible with Yoh. Apply now.

Recruiter: Joan Lowery

Yoh is a professional staffing provider with over 70 years of experience in the short- and long-term staffing services industry; visit our website to learn both about our company and about our leading HR Solutions.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

J2W: CLINICAL; J2W: PROF

MONJOB

Ref: 1021161

SFSF: LS

Job Responsibilities:

- Collect and evaluate information to assist in internal and vendor audits.
- Manage vendor lists.
- Review production and control records using established procedures and guidelines to support lot release of raw materials, components and finished goods.
- Administer electronic systems using established procedures and guidelines to support lot release of raw materials, components and finished goods.
- Support special projects, such as validation, site priority, or new products as required.
- Supports and/or assures completion of annual product reviews.
- Assist in data collection and preparation of trend analysis reports.
- Review for abnormal trends or indications of major problems.
- Performs review of documents related to change management such as work order review.
- Assist in organizing and conducting training sessions and junior staff with problem solving.
- Perform review of technical documents such as for equipment and process validation, automation and computer validation.
- Manages or supports closure Quality system records including investigations, corrective and preventative actions, and change control.
- Update departmental documents such as SOPs as required.
- Attend meetings as a Quality representative and provide input as required.

Job Qualifications:

- BS or BA in Biology, Chemistry, Engineering, Biochemistry, Computer Science, Computer Engineering, or related field.
- Sufficient technical depth or professional experience will be considered in lieu of technical degree.
- Minimum of one (1) year industrial experience in quality organizations, either in operations or assurance functions.
- Knowledge of cGMP in the regulated industry of pharmaceutical production and supply.
- Knowledge of GMP's, NIH Guidelines, FDA and other regulatory agency requirements is preferred.

Discover all that's possible with Yoh. Apply now.

Recruiter: Zachary Stewart

Yoh is a professional staffing provider with over 70 years of experience in the short- and long-term staffing services industry; visit our website to learn both about our company and about our leading professional staffing solutions.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

J2W: SCIENTIFIC; J2W: ENG

MONJOB

Ref: 1021570

SFSF: LS

Available shifts: between 8am - 9pm, Monday - Friday

Job Responsibilities:

- Manually dispense and verify prescriptions.
- Perform quality review on all orders set to Quality Assurance.
- Complete knowledge of pharmacy order process flow.
- Maintain working knowledge of changes in pharmacy practice, including laws and drugs, and apply this knowledge in the performance of daily activities.
- Promote professional environment / behavior in the pharmacy.
- Assist Pharmacy Technicians in task completion.
- Oversee product preparation prior to dispensing product.
- Perform replenishment of automated dispensing modules.
- Process special patient request.
- Ensure proper adherence to all laws and regulations.
- Receive and validate all drug product inventories.
- All other duties as assigned.

Job Qualifications:

- Must have Bachelors or PharmD Degree in Pharmacy.
- Must have current license in good standing in the State of Delaware.
- Prior Specialty Pharmacy, Mail Order or PBM (Pharmacy Benefit Management) experience is preferred.
- Must be detail-oriented.
- Ability to follow all regulatory requirements and Company Standard Operating Procedures to ensure quality patient care.

Discover all that's possible with Yoh. Apply now.

Yoh is a professional staffing provider with over 70 years of experience in the short- and long-term staffing services industry; visit our website to learn both about our company and about our leading professional staffing solutions.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

J2W: HC

MONJOB

Ref: 1021619

SFSF: HC

Job Responsibilities:

- Perform visual and dimensional inspections, as well as functional tests for incoming parts, subassemblies, and finished products, and provide disposition status according to defined procedures and criteria.
- Accurately document the results of the inspections and testing.
- Document QC results, tracking database and provide feed-back.
- Review device history records for compliance to established procedures and Good Documentation Practices
- Initiate Non Conformance Reports as necessary and participate in complaints resolution.
- Prepare quality control reports as necessary.
- Assist in the drafting and revision of operating procedures and data tracking forms related to inspection.

Job Qualifications:

- High School Diploma or equivalent experience in a Life Science Curriculum (Biochemistry, Chemistry, Materials Science, or Medical Devices).
- Minimum two (2) years of experience within an industrial environment, in a FDA and/or ISO regulated medical device Quality setting.
- Working experience under cGMP.
- Hands on experience with microscopy / microscope observations, measuring tools and standard biotech laboratory equipment and practices,
- Excellent English verbal and written communication skills.
- Proficiency with MS Word, Excel and PowerPoint.
- Ability to maintain extreme attention to detail and organization in all aspects of work.
- Ability to quickly learn and apply new skills, procedures and approaches.
- Ability to effectively document procedures, processes, and results.
- Good working knowledge of basic data analysis.
- Proven ability to work collaboratively in a team-based environment.
- Proven ability to handle multiple competing priorities in a fast-paced work environment.

Discover all that's possible with Yoh. Apply now.

Yoh is a professional staffing provider with over 70 years of experience in the short- and long-term staffing services industry; visit our website to learn both about our company and about our leading HR Solutions.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

J2W: ENG; J2W: SCIENTIFIC

Ref: 1021090

SFSF: LS