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Senior QC Manager

3 months ago

Monroe Twp, United States ClinLab Staffing Full time

ESSENTIAL FUNCTIONS:

  • Manage a team of QC managers and supervisors for the production site to ensure consistent, quality materials are produced.
  • Provide quality oversight of manufacturing activities daily and provide oversight on the review and approval of raw material and finished product releases including DHRs.
  • Responsible for reporting Out of Specifications and Deviations to QM management and perform root cause investigations and corrective actions as necessary.
  • Manage the review and disposition of non-conforming material and customer returned material, including rework, scrap, and return to vendor.
  • Establish, monitor, and improve critical KPIs in the QC lab related to invalid OOS, analyst error, training, testing plans, release metrics, and stability testing.
  • Monitor all stages of manufacturing operations to ensure strict compliance with cGMP/SOPs.
  • Ensure all production and QC testing data is recorded in real time.
  • Recommend and support implementation of continual improvements opportunities.
  • Provide training to new associates according to the company SOPs as applicable.
  • Write/update SOP’s as needed pertaining to Quality Control operations in Production environment.
  • Ensure that all data is organized and archived per appropriate workflows and SOPs.
  • Support Internal Audit program and regulatory audits.

QUALIFICATIONS:

  • Bachelor’s degree with 7+ years of experience in a GMP regulated Pharmaceutical/ Medical Device/Nutraceuticals industry, with 3 years in a managerial role.
  • Minimum of 10 years of experience in good working knowledge of ISO/FDA regulations.