Manager, Quality Control

About the role

Oversee a team of QC Analysts and maintain the QC Laboratory in a state of cGMP compliance.

Responsibilities

• Train, coach, and develop QC staff
• Develop, revise, and review SOPs, qualification/validation protocols, and reports
• Write deviations, CAPAs, and own change controls
• Review and provide guidance for deviations/CAPAs generated by QC Analysts
• Review invalid assays and lead invalid assay investigations
• Participate in OOS investigations
• Ensure all analytical data generated by the QC lab is initiated on time and completed within established turnaround times
• Perform review of QC documentation (equipment logbooks, solution preparation records, cell line records, TRFs, etc.)
• Ensure test results are entered into the appropriate reports
• Track and trend reference standards, assay controls, and critical reagents
• Monitor equipment cleaning, preventive maintenance, and calibration schedules
• Review equipment IOQs and re-qualifications
• Drive continuous improvements in QC processes and procedures
• Perform other duties as needed

Requirements

• BS degree in Biological Sciences, Bioengineering, or Chemistry
• 7+ years of experience performing QC activities in the pharmaceutical and biotech industry under GMP guidelines, with demonstrated expertise in multiple disciplines and assays
• 2+ years of supervisory experience
• Advanced experience with QC testing in pharmaceutical or biopharmaceutical laboratories
• Familiarity with analytical testing procedures: qPCR, HPLC, ELISA, Cell-based Assays, etc.

Skills

• Demonstrated ability to manage a team and work independently on projects, reviewing project data and providing summary analysis reports
• Ability to support regulatory and client audits, as well as interact with clients
• Effective negotiation and collaboration-building skills
• Self-motivated, proactive, accountable, and flexible
• Ability to develop, coach, and mentor key employees
• Excellent interpersonal, verbal, and written communication skills
• High attention to detail, organization, and documentation skills
• Strong scientific, analytical, and problem-solving skills with sound judgment
• Comfortable in a fast-paced small company environment with minimal direction and shifting priorities