Quality Control Manager

Position Summary: Responsible for the management of all lab operations and processes. Oversees the testing of raw materials, work in progress, and finished goods in a sound analytical and cost-effective manner. Oversees the batch/product release and the integrity of the manufacturing and Quality processes. Ensures FDA cGMPs compliance. Position Scope:Responsible for the Quality Control Chemistry and Microbiological Testing Laboratories.Manages chemists, microbiologists, and group leaders in the Quality Department (8-10 direct reports, exempt)Position Responsibility: Manages all lab processes to ensure compliance with current FDA and cGMP requirements. Ensures timely testing and disposition of materials/products so that company deadlines are met. Oversees drafting, approval, and maintenance of all lab related documentation including Standard Operating Procedures, Deviations, Methods, Protocols, Investigations, Out of Specification Reports, etc. Develops, approves, and reviews stability testing protocols for finished goods. Coordinates product stability testing within Quality Assurance and Quality Control to support the final product expiration dating.Develops, adapts, and validates testing methods for use at Country Life. Internalizes tests as to limit and reduce amount/cost of third-party testing. Responsible for ensuring methods are current, tracked, and correctly followed.Oversees and manages testing associated with customer complaint investigations.Adheres to change control and deviation process related to lab functions. Assists with monitoring trends and making suggestions for change controls based on repeat deviations.Establishes and maintains raw material and finished product specifications in accordance with USP, FCC, and NSF guidelines.Performs out of specification investigations when testing results are outside of specifications. Works with QA Manager for investigations as needed.Oversees proposed new raw material and product approval process (testing/Quality aspects) to assist with product development.Oversees environmental testing program. Responsible for monitoring microbial air quality and water quality.Oversees and assists with (as needed) all day-to-day lab functions including but not limited to: keeping lab stocked and running efficiently, keeping lab clean, keeping lab equipment calibrated and in good working order.Monitors and maintains standard library to ensure compliance with FDA requirements.Provides leadership and training to the Quality Department staff as needed.Ensures the training of Chemists on the various lab instruments. Supports Director of Quality and QA Manager with compliance audits, those of Country Life and those of third parties used by Country Life. Assists with qualifying third-party suppliers and testing labs.Maintains contract lab questionnaires and testing agreements.Oversees the testing and release of Desert Essence product line. Assists with product development by having various tests/studies performed. Communicates status updates and planning goals with other departments to ensure Country Life functions efficiently as a team.Works with QA, R&D, Manufacturing, and Planning to identify and rectify material/product Quality issues.Contributes to overall achievement by accomplishing related tasks and demonstrating characteristics that exemplify team building and support.Monitors performance of all lab employees. Performs performance reviews, gives positive and negative feedback to employees as needed, issues disciplinary warnings and recommends promotions as needed. The above is not intended to be an all-inclusive list of responsibilities. Other activities may be assigned as required by management.QUALIFICATIONSExperience and Skills:10 years of analytical chemistry lab experience and 5 years of leadership experience working in FDA/EPA and OSHA regulated agenciesComputer Experience both PC- MS Office, word, excel, Outlook & Mainframe systems Excellent leadership and communication abilitiesAbility to work in a team environmentEducation:BS in science related field

Created: 2025-03-03