CAREER PORTAL

Quality Assurance Specialist

Quality Assurance Specialist
External ID # ROCGJP00039210
Philadelphia, PA- ONSITE
12 month W2 contract (with potential to extend or transition to perm)
Pay rate: $38-42/hr - Depending on Education and Experience


Primary Duties
The Quality Assurance Operations Specialist will:

• Performs work under general supervision.
• Provide quality, technical support and oversight during manufacturing activities.
• Review executed batch records and evaluate product and facility deviations; draw conclusions in terms of product disposition.
• Open deviations as appropriate based upon Manufacturing Team and/or CMO notification; provide evidence of document closing at time of product disposition.
• Assure all deviation/investigations, change controls, CAPAs, and/or other required documentation are completed and closed prior to material/lot release.
• Review and evaluate QC testing records and any associated OOS investigations.
• Review, write, revise, and approve SOP’s, technical documents, and reports.
• Perform inspection and release of materials used for production and review vendor certificates for completeness / compliance against approved specifications and collaborate with Material Management to release incoming materials for production.
• Compile and maintain metrics for testing results, quality documentation closure, and disposition and evaluate trending data to identify any irregular trends and notify management as required.
• Provide administrative project management support for Quality Management System integration and improvement projects.
• Provide support for Quality Risk Management governance, including maintenance of documentation, risk register, CAPA plans, etc.
• Support coordination of site Change Control Review Board and change control communications with third party license holder.
• Prepare certificate of compliance (CoC) and/or certificate of analysis (CoA) for products for clinical and/or commercial materials.
• Other assigned responsibilities as established by the QA Operations Lead.

Skills or Requirements:

• Works under general supervision
• Strong attention to detail;
• Ability to manage multiple priorities and tasks in a dynamic environment;
• Proficiency with computer programs;
• Ability to work effectively in a team environment
• Ability to establish facts, define problems, collect data and draw valid conclusions;
• Ability to exercise judgment to determine appropriate corrective actions.
• With guidance from senior dept members ability to create and organize cGMP system procedures based on regulatory / compliance regulations.
• Excellent written and verbal skills;
• Ability to work and communicate with contract manufacturers and testing organizations.

Complexity and Problem Solving

• Ability to define problems, collect data, establish facts, and draw valid conclusions;
• Analysis and problem-solving skills, including but not limited to the ability to review and analyze manufacturing, quality control and validation data.
• Ability to participate on cross-functional teams in root cause analysis and solution identification.
• Ability to work collaboratively in the process of conflict resolution for resolve deviations, effective CAPA’s, and identifying requirements to implement changes in a controlled GMP environment

Education:

• Bachelor’s Degree in scientific discipline;
• Minimum of 3-5 years in a regulated manufacturing environment with exposure to Quality and Manufacturing field.
• Knowledge of Quality Systems such as Change Control, Investigations and CAPA;
• Ability to communicate effectively with wide range of personnel;
• Technical writing skills related to investigation reports.
• General working knowledge of relevant governmental regulations, cGMP and guidelines.

What’s In It For You?
We welcome you to be a part of one of the largest global staffing companies to meet your career aspirations. Yoh’s network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh’s extensive talent community that will provide you with access to Yoh’s vast network of opportunities and gain access to this exclusive opportunity available to you.

• Medical, Dental & Vision Benefits
• 401K Retirement Saving Plan
• Life & Disability Insurance
• Direct Deposit & weekly ePayroll
• Employee Discount Programs

Estimated Min Rate: $42.00
Estimated Max Rate: $60.00


What’s In It for You?
We welcome you to be a part of the largest and legendary global staffing companies to meet your career aspirations. Yoh’s network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh’s extensive talent community that will provide you with access to Yoh’s vast network of opportunities and gain access to this exclusive opportunity available to you. Benefit eligibility is in accordance with applicable laws and client requirements. Benefits include:

• Medical, Prescription, Dental & Vision Benefits (for employees working 20+ hours per week)
• Health Savings Account (HSA) (for employees working 20+ hours per week)
• Life & Disability Insurance (for employees working 20+ hours per week)
• MetLife Voluntary Benefits
• Employee Assistance Program (EAP)
• 401K Retirement Savings Plan
• Direct Deposit & weekly epayroll
• Referral Bonus Programs
• Certification and training opportunities

Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.

For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

By applying and submitting your resume, you authorize Yoh to review and reformat your resume to meet Yoh’s hiring clients’ preferences. To learn more about Yoh’s privacy practices, please see our Candidate Privacy Notice:  https://www.yoh.com/privacy-notice