Supervisor, Quality Control Laboratory

About the role

The Supervisor, Quality Control Laboratory will oversee QC laboratory operations and align resources with testing needs. This position is the primary point of contact for Manufacturing and other departments for the respective shift. The role performs the most complex chemical testing of intermediate and finished products according to written procedures and maintains QC instrument operation and reliability. Instrument troubleshooting and method optimization are required to enhance lab throughput, along with training others on current test methods and assisting with implementation of new methods.

Responsibilities

• Manage communication between respective shift and other shifts as well as management concerning daily activities in the Quality Control lab.
• Manage communication with other departments (MFG, Maintenance, R&D).
• Complete performance reviews and assist Manager in providing input for performance reviews of other personnel not on their shift.
• Set priorities for the shift and allocate work within the shift to ensure priorities are completed on time.
• Audit data when necessary.
• Demonstrate advanced knowledge of various test methods and instrument analysis techniques and be proficient with all sample types and test methods.
• Perform more advanced troubleshooting/maintenance of the instrumentation.
• Perform more complex physical and chemical testing of intermediate and finished products as described in the documented procedures to support product release and process validation protocols.
• Demonstrate proficient ability to operate the instrument software applications, troubleshoot software and report data.
• Perform swabbing and analysis of more complex manufacturing equipment in accordance with cGMP guidelines.
• Provide input on cleaning related issues and investigations.
• Investigate Out of Specification results, Out of Trend results and deviations in accordance with cGMP guidelines.
• Assist Management with writing and completion of investigation sections and product impact as required.
• Train others as required as it pertains to LIR/OOS procedures.
• Train other Chemists on current and new test methods.
• Accurately maintain notebooks and files compliant with current GMPs and internal Standard Operating Procedures.
• Peer review and/or audit others work as required for verification of GMP compliance.
• Audit laboratory testing data as required.
• Perform cost savings and process improvement projects as required.

Experience, Education, And Skills

• Bachelor’s degree in Chemistry or closely related field and 5+ years of experience working in a Chemistry Laboratory, Quality Control or Research and Development Laboratory, in the pharmaceutical industry.
• M.S. in Chemistry or closely related field and 3+ years of experience working in a Chemistry Laboratory, Quality Control or Research and Development Laboratory in the pharmaceutical industry.
• Experience managing a team.
• Excellent written and oral communication skills.
• Organized with exceptional attention to detail.
• Advanced knowledge of laboratory procedures, equipment, instrumentation, safety procedures and laboratory practices which also includes lab networks and data integrity practices.
• Knowledge and application of regulations relating to product stability.
• Ability to work independently on multiple projects in a dynamic and fast-paced environment.
• Possess computer skills including Microsoft Office applications.
• Ability to contribute to cross-functional teams.
• Possesses initiative with a proactive attitude to problem-solving, and has a desire to learn new skills.

Benefits

• Medical, dental, and vision coverage.
• Retirement plan with company match.
• Paid time off and company holidays.
• Tuition reimbursement with no waiting period.
• Life insurance.
• Pet insurance.
• Flexible Spending Accounts (medical and dependent care).
• Disability coverage.