Quality Control Manager
2 weeks ago
Job Title: Quality Control Supervisor
Job Summary:
We are seeking a highly skilled Quality Control Supervisor to join our Chemistry department at a leading biotech research company. The successful candidate will be responsible for organizing, planning, and directing the activities of the staff, as well as coordinating the installation and qualification of new analytical equipment.
Responsibilities:
* Supervise and lead the QC Chemistry Staff, including hiring, supervision, coaching, mentoring, discipline, and performing annual review assessments.
* Coordinate and QC analytical testing for GMP release and stability testing.
* Ensure QC equipment is maintained in a qualified state.
* Prepare and execute tech transfer, qualification, and validation protocols and reports as needed.
* Write, revise, and review Standard Operating Procedures (SOPs) and other Good Manufacturing Practices (GMP) documentation.
* Establish a system for managing test samples, reagents, and reference standards.
* Review and approve data/reports during release & stability testing.
* Ensure laboratory compliance to established specifications and procedures.
* Reports excursion/out of specifications results and conducts investigations as needed.
* Assure the implementation of appropriate and timely corrective actions.
* 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.
Requirements:
* Master's degree preferably in Chemistry or Biochemistry with at least four (4) years' industry experience OR Bachelor's degree preferably in Chemistry or Biochemistry with at least six (6) years' industry experience in a GMP/GxP or a comparable federally regulated environment of which two (2) years are in a lead or supervisory role.
* Analytical laboratory experience in a GLP/GMP regulated environment is preferred.
* Experience in Trackwise Deviation Management software.
* Experience in Empower 3 software.
* Sound understanding and knowledge of SEC, UPLC, and Capillary Electrophoresis instrumentation and methodologies.
* Ability to follow safety procedures outlined in the Chemical Hygiene Plan.
* Utilize MSDS sheets to properly assess chemical hazards, spill response procedures, and PPE requirements if indicated.
* Develop staff to maximize contributions to team and company.
This job description is a complete list of all desired skills but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you.
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