The QC Manager will be responsible for managing Analytical and Biochemistry testing within the cGMP Quality Control labs. The manager will be responsible to manage a team of analysts and scientists focused on the analysis of stat, release and stability testing of biotechnology products. The manager will have accountability for exceptions associated with test execution (deviations, CAPAs, OOS, OOT) and be expected to manage each to their timely closure in partnership with technical product leads, the clients and Quality Assurance.
The performance of the team is measured against milestones established on a monthly basis, ownership of the testing milestones resides with the QC management team. The position will be expected to work with peers in Quality Assurance, Analytical Method Technology and Analytical Development to ensure testing turnaround times are met and in accordance with cGMP expectations. The department’s core responsibilities are centered on providing manufacturing support for STAT in-process assays, stability testing of drug substance and client drug product samples, release testing and supplement (protocol based) testing.
A core responsibility of the QC manager will be ensuring the development of the staff. It is the expectation that a culture of ownership and accountability is fostered at all levels within the laboratory setting.
MAJOR ACTIVITIES AND RESPONSIBILITIES:
- Manage the QC Chemistry Staff, including hiring, supervision, coaching, mentoring, discipline, and performing annual review assessments.
- Coordinate and oversee QC analytical testing for GMP batch release and stability testing.
- Ensure QC equipment is maintained in a qualified GMP state.
- Write, revise, and review Standard Operating Procedures (SOPs) and other Good Manufacturing Practices (GMP) documentation.
- Assist in developing and managing QC budget.
- Review and approve data / reports during release & stability testing, as required.
- Ensures laboratory compliance to established specifications and procedures.
- Report excursions/out of specifications results and conducts investigations as needed.
- Assure the implementation of appropriate and timely corrective actions.
- Work closely with Quality Assurance and other departments to continuously improve the effectiveness of the Quality Control team.
- Work collaboratively with manufacturing and product development teams to improve quality, increase efficiency, solve problems, generate cost savings, and provide new product support.
- Interface with current and potential clients as well as interface with investigators during internal and external inspections.
- Follow all established laboratory, regulatory, safety, and environmental procedures.
- Identify deviations and report possible preventative and corrective actions using Trackwise.
- Perform other duties as assigned.
- Master’s degree preferably in Chemistry or Biochemistry with at least six (6) years’ experience in a GMP environment of which three (3) years are in a lead or managerial role; OR
- Bachelor’s degree preferably in Chemistry or Biochemistry with at least eight (8) years’ experience in a GMP environment of which three (3) years are in a lead or managerial role.
- AND at least 5 years’ experience in a GMP environment.
- Analytical laboratory experience in a GLP/GMP regulated environment is preferred.
- Experience in Systems, Applications and Products (SAP) software.
- Experience in Trackwise Deviation Management software.
- Experience with SmartQC scheduling and planning software preferred.
Specific Skills and Competencies
- Sound understanding and knowledge of UPLC, HPLC, and Capillary Electrophoresis instrumentation and methodologies.
- Thorough understanding of the pharmaceutical/biotech testing.
- Coordinate staff scheduling and training, mentor employees, and provide constructive criticism.
- Utilize SDS sheets to properly assess chemical hazards and PPE requirements if indicated.
- Develop staff to maximize contributions to team and company.
- Ability to multi-task and prioritize work assignments with little supervision.
- Ability to accurately review and complete required documentation.
- Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships
- Capable of interfacing with multiple levels of people within the organization, including corporate management, third party customers, and plant personnel.
- Proven ability to understand and implement data integrity standard and regulations
- Ability to put complex thoughts and issues into writing in such a manner that an educated, but uninformed reader can understand and make decisions based on the written investigation report
- Ability to work cross-functionally with a diverse team