San Francisco, CA
Technical Writer
Job Details
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.
Education:
BS in Bio/Chem Science/Engineering or related field.
Immunology education is preferred.
Experience :
3+ years relevant experience in drug product biopharmaceutical or equivalent industry.
Deviation writing.
cGMP/cGDP.
Ability to prioritize multiple investigations in order to meet deadlines.
Strong scientific and technical acumen including technical writing skills.
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.
Cynet Systems
05/11/2024
Libertyville,IL