Quality Control Supervisor - Astrix : Job Details

Our client is a leading biotech research company focusing on advancing medicine is targeting a QC Supervisor to join their Chemistry department that will be responsible for organizing, planning, evaluating routine, and directing activities of the staff, as well as coordination of installation and qualification of new analytical equipment.

• Salar: 90-100k/yr.
• Terms: Direct Hire
• Schedule: 8am-5pm, Monday-Friday

As a QC Chemistry Supervisor, you will support GMP release and stability testing, with leading tech transfer activities of qualified analytical methods, and will play a pivotal role in selecting qualified members to join the QC Chemistry Lab.

What you will be doing:

• 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.
• Ensures 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.

What you bring to the company:

• 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**