Quality Manager
Apply NowCompany: Katalyst HealthCares and Life Sciences
Location: Swiftwater, PA 18370
Description:
Roles & Responsibilities:
- Bachelor's Degree/Undergraduate Degree in engineering or technical discipline or Master's degree preferred.
- 10+ Years Experience in pharmaceutical/biopharmaceutical industry or related industry/manufacturing environment.
- Experience in Bulk Formulation and Aseptic Filling.
- Strong working knowledge of Quality System Regulations.
- Experience leading CAPA (Corrective and Preventive Action) activities.
- Quality review for documents associate with protocols, functional spec, detail design specs, site acceptance test, data packs.
- lso, investigate deviations and will be final approver on such documents.
- bility to work on strict deadlines.
- bility to interface with cross-functional teams.
- Detail oriented.
- bility to handle multiple projects concurrently.
- Well-developed communication skills, both verbal and written.