Quality Control Supervisor

Updated: May 1, 2019
Job ID: 214789
Status: Full-Time
Regular/Temporary: Regular
Location: Silver Spring, MD, United States

Join the HJF Team!

HJF is seeking a Quality Control Supervisor to support our Vaccine Development and Production (VDP) Team for the Military HIV Research Program (MHRP) in the establishment and implementation of quality control systems in accordance with cGMPs and cGLPs. This position will be located at the Walter Reed Army Institute of Resreach (WRAIR) in Silver Spring, Maryland. HJF provides scientific, technical and programmatic support services to VDP/MHRP. 

This position develops, implements and manages quality control systems designed to ensure continues production of advanced HIV vaccine materielas and applications consistent with established standards, specifications and production goals. The position supervises a team of quality control research associates and reports to VDP Quality Affairs Management.  

Responsbilities: 

  • GMP Activities -
  1. Establish lab policies and procedures and oversee lab operations to ensure they comply with the local and international laws and regulations as well as FDA, EU, ICH, and other regulatory expectations and requirements as required.
  2. Manage the operation of the Quality Control functions and assist in directing VDP quality control strategy.
  3. Train and supervise Quality Control personnel, assign tasks, and evaluate staff members' work.
  4. Review executed manufacturing batch records and analytical method validation reports.
  5. Execute analyses in accordance with GMP to determine disposition of manufactured materials and issue CoAs.
  6. Develop and approve internal and external analyses.
  7. Author, edit, and review Laboratory Test Methods, Technical Reports, SOPs, Laboratory Investigation Reports (IR), Material Specifications, Master Specifications, and any other documentation required.
  8. Lead and manage investigations for internal Out of Specification (OOS), Out of Trend (OOT) and corrective actions in accordance with VDP Quality Systems.
  9. Review and approve OOS, OOT, investigations and corrective actions initiated by Contract Testing Laboratories.
  10. Find and screen suitable new contract test labs as needed.
  11. Lead the technical transfer and qualification of test methods into and out of the QC lab. 
  12. Help schedule and host audits and investigations of QC lab practices by sponsors and regulatory agencies.
  13. Assist in external audits and evaluations of analytical service providers.
  14. Author, review and approve Process Intermediate and Drug Product specifications.
  15. Establish, implement, and monitor VDP’s product stability program and issue interim and final reports.
  16. Review and provide inputs for CMC sections of IND and IMPDs.
  17. Assist in the development, review, and approval of documents (IBs, Products Specs, Pre-IND, IND) governed by in-house and external Quality Systems.
  18. Ship analytical samples, product and ingredients.
  19. Enforce within QC, approved priorities, timelines, budgets, and decisions made by leadership and inform VDP of any delays, issues, etc.
  20. Coordinate tasks with sponsors, contract manufacturing and testing organizations as required.
  • Development (non-GMP) Activities -
  1. Assist in the development of Reference virus  and MVA-HIV products for analytical, and research (non-human) use.
  • Contracts and Budgets - 
  1. Evaluate invoices for payment to contract testing organizations.
  2. Project, execute, and manage the budget for the QC area.
  3. Prepare requests for contract actions and proposals as related to QC.
  4. Additional duties as assigned.

Required Knowledge, Skills and Abilities: Must recognize, accommodate and work safetly with routine laboratory hazards. High level of organizational skills required. Good writing skils in technical/scientific English (provide sample). Ability to interpret comples scientific information and perform all necessary algebraic and simple statistical calculations to recommend course of actions. 

Minimum Education: Master’s degree from an accredited college/university in a scientific discipline required in technical or laboratory science (chemistry, biology, biochemistry, immunology, virology etc.) with strong analytical component. Foreign degrees must be evaluated for U.S. equivalency.

Minimum Experience/ Training Requirements: 2 - 4 years of related experience in managing a regulated laboratory (GLP or other accreditation) and working under Quality Systems. Work in vaccine/biologics field and previous experience working with the FDA is desirable. Experience writing technical and regulated documents is required.

Physical Capabilities: Prolonged sitting while using a personal computer. Minor lifting ( <20lbs).

Supervisory Responsibilities/Controls: Supervises Quality Control Research Assistants.

Work Environment: Office and Laboratory Settings; availability to address urgent issues on weekends and evenings is expected. Some CONUS and OCONUS travel required.

Background: Must have lived in the US 3 out of the past 5 years; eligible to pass a NACI background.

Employment with HJF is contingent upon successful completion of a background check, which may include, but is not limited to, contacting your professional references, verification of previous employment, addresses, education, and credentials, a criminal background check, drug screening, and a department of motor vehicle (DMV) check.  

HJF is an equal opportunity and affirmative action employer.  All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Chief Human Resources Officer.
 

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