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

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