Provides general supervisory support to the Quality Assurance and Quality Control Inspection departments in a cGMP manufacturing environment. Possesses and applies a broad knowledge of Quality principles, practices, and procedures. Assists in the maintenance of company quality policies and procedures to ensure compliance with regulatory requirements. Manages and supports the Material and Finished Goods Release process, Document Control process, Change Control process, Corrective and Preventive Action (CAPA) system, deviation process, nonconforming material process, calibration, and supplier qualification process. Must be able to lead and work with cross-functional teams and track projects to completion. Requires experience in GMP manufacturing environment plus demonstrated familiarity with standard quality concepts, practices, and procedures.
- Provide project direction, coaching and mentoring for company personnel. Proactively initiate the development of streamlined systems to effectively identify and resolve quality problems process improvement opportunities.
- Write and revise SOPs and controlled forms and related documents to ensure best practices and current operations.
- Review cGMP related documentation for compliance such as batch records and associated data related to product manufacturing, testing and release, stability studies, validation protocols and reports, deviation and investigation reports, labels, product specifications, monographs and other documentation.
- Manage material, component, and finished product release.
- Provide and support training of personnel. Ensure that GMP training is completed annually. Provide ongoing support to all employees on quality system requirements and problem solving.
- Participate in internal audits of various departments/processes including planning of audits, execution, preparation and communication of audit reports, and follow-up on findings.
- Lead the Corrective and Preventive Action (CAPA) team. Work with CAPA team members to determine root cause and develop action plan. Follow up on action plan implementation to ensure effectivity and timely closure.
- Participate in process improvement teams to provide quality input and direction. Ensure that documentation of improvements are completed and approved as needed.
Supervisory experience and experience in manual and electronic quality systems a plus. Quality Engineering experience a plus. 4-year college degree with four to eight years related experience; or equivalent combination of education and experience required.
Wage: DOE, with full benefits after 60-90 days.
To apply, please send resume along with cover letter stating wage history/wage required, as well as a completed Thorne employment application to:
Thorne Research, Inc.
P.O. Box 25
Dover, Idaho 83825
Thorne Research is an Equal Opportunity and Drug-Free Employer