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 staffDevelop, 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 AnalystsResponsible for reviewing invalid assays and lead invalid assay investigationsParticipating in OOS investigationsResponsible 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 ReagentsTrack equipment cleaning/PM/Calibration schedules Review equipment IOQ’s and Re-Qualifications QC Process/Procedure continuous improvements Perform other duties as neededEDUCATION 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 laboratoriesFamiliarity 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 dataAbility 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 flexibleDemonstrate 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 skillsStrong scientific, analytical, and problem-solving skills as well as sound judgment, to identify problems and leads efforts to resolve themComfortable in a fast-paced small company environment with minimal direction and able to adjust workload based on upon changing priorities.EOE/MFDV