Upvote
Downvote
Sr. Specialist, Quality Assurance
Share Job
- Suggest Revision
- Demonstrates ability to review and disposition documentation in a timely manner, such as: manufacturing batch records, EM records, validation documentation, change controls, process qualifications, on-site material preparations, equipment qualifications and/or planned maintenance, material acceptance, cleaning documents, etc.
- Demonstrates ability to analyze and interpret results from chromatograms by HPLC, Gas Chromatography, and E-Z Scan radiometric TLC scanner.
- Demonstrates an understanding of quality concepts such as: cost of quality, analytical metrics and / or statistics, trending, quality planning, validation, CAPA and problem solving.
- Responsibilities Handles CGMP documentation review related to product release, facilities and equipment, material controls, laboratory controls, packaging and labeling, and production & process controls.
- Handles and ensures quality of documentation (control, retention, and archival) to support CGMP activities.
Active Job
Updated TodaySimilar Job
Relevance
Active