Responsibilities
- 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.
Requirements
- Bachelor’s degree with 7+ years of experience in a GMP regulated Pharmaceutical / Medical Device / Nutraceuticals industry, with 5 + years in a managerial role.
- Minimum of 10 years of experience in good working knowledge of ISO / FDA regulations.
- Experience handling FDA / GMP audits is a plus.
Benefits
- Health, Dental & Vision
- 401(k)
- Incentives
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