Position
Quality Control Manager-1st Shift (Lynchburg, VA)
Department:
Quality Assurance
For over 150 years, Fleet Laboratories, a Prestige Consumer Healthcare Company, has adapted to consumer needs with creative thinking and innovative product development. We are a global leader of over 100 personal health and beauty care products that consumers have come to trust: Summer’s Eve, Dramamine, Clear Eyes, Fleet Enema, Compound W, Luden’s, TheraTears, DenTek and dozens more helping people look and feel their best.
We are looking for a Manager, Quality Control for 1st Shift. To Manage the Quality Control Laboratory staff responsible for microbiological and chemistry analyses on raw material, in process, and finished products using established analytical methods and incoming physical analysis of components and raw materials for an OTC drug and cosmetic manufacturing facility. Manage the technical expertise provided to R&D regarding development of product preservative systems. Manage the transfer of new test methods and validation. Responsible for the documentation related to OOS and CAPA Quality activities, and interaction with outside laboratories.
WHAT YOU’LL DO
- Develop and manage the functions for chemical and microbiological analysis and disposition of chemicals, in-process products, and finished products.
- Budgetary responsibility of approximately $850,000.
- All analytical data generated in the QC lab meets cGMP, SOP, data integrity standards and regulatory requirements.
- Manages the QC staff, chemistry and micro testing schedules, budget, environmental monitoring and training.
- Interacts with federal, state, and local regulatory officials during regulatory inspections.
- Investigates and determines root cause of Out of Specification and failure investigations and communicates to upper management.
- Approval or rejection of all QC SOPs to ensure they are up to industry standards and cGMP requirements.
- Training, coaching and development of QC Staff members.
- Responsible for all analytical data generated by QC Labs to meet cGMP requirements, GDP practices and data integrity practices.
- Provide technical assessments and risk analysis for investigations.
- Provides and approves data for the Annual Product Review for commercial products.
- Develops capital equipment and operational budgets.
- Manage equipment service agreements to maintain qualified, calibrated equipment fit for use.
- Manage all testing at contract labs; ensure all testing facilities have been qualified to meet Fleet Labs and regulatory requirements.
- Develop and manage the function for physical and functional analysis and physical disposition of packaging components, in-process and finished product.
- Test and qualify new raw materials.
- Manage a variety of quality programs, including Hazardous Communication and Contamination Control.
- Participate in management and auditing of contract testing labs.
- Assure proper chemistry, microbiological and packaging specifications for raw materials, in –process and finished products.
- Recognize and react to product and process chemical and microbiological problems, and lead problem solving efforts.
- Ensure Laboratory and Inspection group compliance with safety and regulatory requirements and provide a variety of written documentation, reports, and analyzes.
- Provide technical leadership and support to new product projects.
- Provide technical support and coordination to a variety of corporate programs.
EDUCATION AND EXPERIENCE, YOU WILL BRING
- BS degree in Chemistry or Microbiology, MS preferred.
- Minimum of seven years of QC lab related work experience in pharmaceuticals.
- Minimum of 4 years of supervisory/management experience required.
WHAT WE OFFER
Come join a manufacturing business producing familiar iconic brands that you know and use, a business that has supported the Lynchburg community for over 150 years. Take the first step toward a great career and enjoy:
- Our wonderfully diverse and talented employees
- A clean, air-conditioned cGMP environment
- Our training and employee development programs helping to make tomorrow’s leaders
- Our top-notch benefits that include paid time off, 401(k) retirement savings with company match, medical, dental, vision, life and disability insurance, competitive pay, a flexible spending account, tuition reimbursement and more
- Our stability and historically strong record of financial performance year-after-year
Learn more about us at www.prestigebrands.com
Prestige is an Equal Opportunity Employer
Search Firm Representatives - Please read carefully:
PRESTIGE CONSUMER HEALTHCARE does not accept unsolicited assistance from search firms. Please, no phone calls or emails. All resumes sent by search firms to any employee at Prestige Consumer Healthcare via-email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Prestige Consumer Healthcare. No fee will be paid in the event the candidate is hired by Prestige Consumer Healthcare as a result of the referral or through other means. Thank you for your cooperation.