Summary : The Arden Hills Supplier Quality Engineering team is looking for high-energy, driven, passionate people! The Supplier QA Engineer will play a key part in leading performance improvement of suppliers and increasing the suppliers...
Summary: The Lead Validation Engineer will oversee and drive commissioning and qualification (C&Q) activities for automation and process systems at a regulated manufacturing site. This leadership role is responsible for ensuring validation...
Responsibilities: Participate in the development of the CMC regulatory strategy for small molecules. These submissions include health authority briefing packages, IND/CTA, NDA, and MAA regulatory filings. Prepare and review CMC submissio...
Roles & Responsibilities: Bachelor's degree in engineering, Computer Science, Life Sciences, or related field. 2-10+years of experience in computerized systems validation within pharmaceutical, biotechnology, or life sciences indus...
The Regulatory Affairs Associate will be responsible for managing, authoring, and compiling Chemistry, Manufacturing, and Control (CMC) sections of regulatory submissions for marketed product variations, including Class III implantable medi...
Summary: Responsible for preparing and executing test documentation for GMP computerized systems as well as providing support in the troubleshooting of issues during test execution. You should have excellent understanding of 21 CFR Part ...
Responsibilities: Generate, execute, review, finalize, and approve validation/qualification protocols and reports. Manage and update project validation plans for specific projects. Assist and deliver amendments to the qualification(s) t...
Responsibilities: With direct supervision, candidate is responsible for support and execution of QC laboratory equipment qualification activities while in full compliance with current cGMP regulations and Roche/Genentech corporate princip...
Summary: Analyze document current and future business process models, high-level requirements (scope), and detailed functional specifications or agile user stories with acceptance criteria. Guide and support other Business Analysts and Pro...
Summary: With direct supervision, candidate is responsible for support and execution of QC laboratory equipment qualification activities while in full compliance with current cGMP regulations and Roche/Genentech corporate principals, qual...