Manager, Quality Control

Job Title: Manager, Quality Control

Department: Quality Control - Analytical

GENERAL DESCRIPTION:

• QC Manger is responsible for overseeing a team of QC Analysts and is also responsible for maintaining the QC Laboratory in a state of cGMP compliance.

DUTIES AND RESPONSIBILITIES:

• Training, coaching, and development of QC staff
• Develop, revise, and review SOPs, qualification/validation protocols and reports.
• Write deviations, CAPA's and own change controls.
• Review/Provide guidance for deviations/CAPA's generated by QC Analysts
• Responsible for reviewing invalid assays and lead invalid assay investigations
• Participating in OOS investigations
• Responsible for ensuring all analytical data generated by QC lab to be initiated on time and completed within established TAT's.
• Perform review of QC documentation (equipment logbooks, sol'n prep record, cell line records, TRF's, etc)
• Ensure test results are entered into the appropriate reports
• Track/Trend Ref. Std, Assay Control and Critical Reagents
• Track equipment cleaning/PM/Calibration schedules
• Review equipment IOQ's and Re-Qualifications
• QC Process/Procedure continuous improvements
• Perform 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 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.

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.

EOE/MFDV