Quality Control Manager/Team Leader

Bachelor of Science, Biological sciences, Chemistry, or other related sciences.
Demonstrated knowledge of compliance, quality and scientific principles in a FDA regulated environment is required.
Minimum of 5 years progressive experience in the Quality Control.
Minimum of 3 years leadership experience (Preferred).
Detailed knowledge of Good Laboratory Practices (GLP) and Good Manufacturing Practices (cGMP).
Fluency in quality systems and regulatory compliance.

Daily batch report review and approval.
External lab management.
3rd party lab result data entry.
OOS trending and reporting.
Stability testing.
Environmental Monitoring.
Internal Sample Management.
Internal testing.
Laboratory supplies management.
Obtain testing and retention samples from bulk containers of raw ingredients and finished products.
Maintain accurate records of all testing performed in a manner consistent with cGMP regulations.
Ensure laboratory equipment is maintained and calibrated according to the maintenance schedule.
Assures that products conform to established specifications of purity, quality, and composition.
Works with support of the Site Quality Leader to establish in-house assay methods and criteria for assays from independent laboratories.
Keep all product file information current and up to date.
Makes recommendations to improve Product Quality/Product Assurance/cGMP standards.
Create relevant and appropriate laboratory SOPs.
Create various specification documents.
Assist with various activities relating to regulatory compliance.
Reviewing, testing, and approving Finished, WIP, and raw materials for use and their associated batch reports.
Sampling of raw materials in accordance with cGMPs, as they are received in warehouse.
Maintaining all documents associated with FDA, USDA, EMA and cGMP compliance.