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Precigen
Manager, Quality Control
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What they do
A Quality Control Manager focuses on detection of mistakes and defects in manufacturing products. Develops procedures and tests to identify any irregularities and error in the output. Manages and oversees all steps related to quality control as part of the quality management strategy of a company. May involve leadership of a team of quality control technicians and other associated staff members.
$110,088 / year median in Maryland
+6% projected growth
Job Description
Manager, Quality Control
Job Title:
Manager, Quality ControlDepartment:
Quality Control - AnalyticalGENERAL 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.