Title: Quality Auditor - Scientific – III
Location: West Point, PA
Schedule: 8am to 5pm Mon – Fri.
Start date: ASAP
- Under the direction of supervision, the scientist manages change control for Analytical documents (including drafting of testing methods and specifications)
- Reviews methods and specifications to ensure alignment with Good Manufacturing Practices (GMPs) and other applicable worldwide regulations.
- Review and approve production and analytical documentation accompanying the release of API, Safety Assessment or clinical supply lots (bulk and packaged) to ensure conformance to appropriate regulatory requirements.
- In addition, the Scientist communicates and resolves comments with client areas.
- B.S. and/or M.S. in an appropriate Science or Engineering discipline.
- Minimum of 5 years of laboratory experience required.
- Experience should be in the pharmaceutical/chemical industry or government drug-regulatory agency with a working knowledge of cGMP regulations.
- Working experience should include experience performing laboratory methods, assay development, and document review.
- Effective communications (oral/written) and interpersonal skills are necessary along with technical writing skills.
Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.
Total Quality Management
Provide Technical Guidance