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Senior QC Manager
1 week ago
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.
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