Position Summary:
Establish and ensure appropriate Quality are maintained, including ongoing data analysis of product and process outputs to ensure early detection and response to quality concerns and prevention of quality issues.
Job Functions:
- Manage all aspects of plant Quality Operations for floor level focus factory quality engineer support.
- Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e., FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).
- Hire and manage departmental personnel directly and through subordinate leaders.
- Support an aggressive Quality program which instills personal accountability for accuracy, consistency and completeness for all operations and departments according to site and corporate policies.
- Create and maintain an environment of excellence, world-class quality and continuous improvement throughout the entire plant.
- Responsible for making fact-based, scientifically sound, quality decisions regarding products manufactured at the Maryland Heights facility.
- Ensure the appropriate process, equipment and facility validations meet expectations for validations, process capability, corrective actions and general compliance for applicable regulatory agencies.
- Ensure accountability, transparency, and effective communication cross-functionally and within the team while ensuring information is timely, clear and accurate.
- Coach and develop the team to High Performance while fostering a culture of team ownership.
- Ensure team compliance with all policies, procedures and site/company regulations.
- Set clear vision by ensuring goals and objectives are aligned with site strategies and managing each team member’s performance management.
- Exhibit accountability and responsibility for an area or process in order to affect change and lead efforts and ideas to completion.
- Provide leadership for employee relations through effective communications, coaching, training and development and eliminate roadblocks in order for the team to move forward.
- Supply the highest level of internal and external customer service while having the ability to diplomatically challenge established procedures and systems.
- Understand and provide education and feedback to team regarding business and financial impact of decisions/actions.
- Ensure proper maintenance and cleanliness of the department, premises and equipment.
- Measure and communicate team’s progress against individual, team and site goals and Key Performance Indicators (KPIs).
- Bachelor’s degree in Physical Science, Chemistry, or Life Science required, Master’s degree preferred
- 12 or more years of multi-functional Quality experience to include Quality Assurance, with 2 or more years in a leadership role(preferably managing a team of degreed professionals)
- Expert knowledge of cGMP requirements, specific to Pharmaceutical and/or Chemical industry experience required
- Complete understanding and application of principles, concepts, practices, and standards for testing performed in QC laboratories
- Strong working knowledge of US and international requirements and guidance documents.
- Thorough understanding of Quality systems
- Ability to use relevant software packages to process and analyze data.
- Team orientation/strong team player
- Excellent and proven decision making, problem solving and analytical skills
- Technical writing skills
- Lean / Kaizen / Six Sigma experience preferred
- Experience with developing/documenting procedures
Estimated Min Rate: $91000.00
Estimated Max Rate: $130000.00
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.
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