Vacancy caducado!
Our client, a leading pharmaceutical company, is hiring a Project Manager, on a contract basis.
Work Location: Bothell, WA Summary: The MSAT Tech Writer:- Compiles and interprets manufacturing process data to identify possible failure modes.
- Learns complex cell biology concepts & applies them to root cause investigations.
- Works independently and with Process Engineer(s) to understand different failure modes.
- Works with GMP Quality Systems to deliver completed Root Cause Analysis investigation reports.
- BS in Bio/Chem Science/Engineering or related field.
- Immunology education preferred.
- 1 year relevant experience in drug product biopharmaceutical or equivalent industry
- cGMP/cGDP.
- Ability to prioritize multiple investigations to meet deadlines.
- Strong scientific and technical acumen including technical writing skills.
- Deviation writing
- Quality management system
- Complex problem-solving skills, including root cause investigation
- Cross-functional collaboration with engineering and quality partners
- Biologics or cell therapy manufacturing
- Trained in Kepner Tregoe Problem Solving
- Facilitates deviation closure through working with quality partners and site quality systems.
- Analyzes and summarizes manufacturing data to support root cause investigations.
- Analyzes and summarizes characterization data to write root cause investigations.
- Utilizes root cause analysis tools such as Kepner Tregoe Problem Solving to identify root cause.
- Writes technical and thorough investigation reports.
Vacancy caducado!