QC Manager

Duties and Responsibilities

• Training, coaching, and development of QC staff
• Develop, revise, and review Standard Operating Procedures (SOPs), qualification/validation protocols and reports
• Write deviations, Corrective and Preventative Action (CAPA) documents, and own change controls
• Review/Provide guidance for deviations/CAPA’s generated by QC Analysts
• Responsible for reviewing invalid assays and leading invalid assay investigations
• Participating in Out-of-Tolerance (OOS) investigations
• Ensuring all analytical data generated by QC lab is initiated on time and completed within established Turnaround Times (TAT’s)
• Performing review of QC documentation (equipment logbooks, solution preparation records, cell line records, Reference Standard Transfer Forms (RTFs), etc.)
• Ensuring test results are entered into the appropriate reports
• Tracking/Trending Reference Standards, Assay Controls, and Critical Reagents
• Tracking equipment cleaning/Preventive Maintenance (PM)/Calibration schedules
• Reviewing equipment In-Use Qualification (IOQ’s) and Re-Qualifications
• Conducting QC process/procedure continuous improvements
• Performing other duties as needed

Education and Experience

• BS degree in the Biological Sciences, Bioengineering, or Chemistry
• 7+ years of experience performing QC activities in the pharmaceutical and biotech industry under Good Manufacturing Practices (cGMP) 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.

Desired Key Competencies

• Demonstrated ability to manage a team and work independently on projects, and review project data and provide summary analysis reports based upon the data
• Ability to provide support for regulatory and client audits, as well as interact with clients
• Ability to effectively negotiate and build collaboration amongst individuals
• Ability to be self-motivated, proactive, accountable, and flexible
• Demonstrate the ability to develop, coach and mentor key employees
• Excellent interpersonal, verbal, and written communication skills are essential in this collaborative work environment
• High attention to detail, highly organized, and excellent documentation skills
• Strong scientific, analytical, and problem-solving skills as well as sound judgment, to identify problems and leads efforts to resolve them
• Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based on upon changing priorities