Job Description :
Pay Range $56hr - $59hr
Responsibilities :
- 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 fishbone, 6Ms, Five Whys, to identify root cause.
- Writes technical and thorough investigation reports.
Must Have :
- 3+ years of experience with the following.
- Relevant experience in drug product biopharmaceutical or equivalent industry.
- Investigation.
- Deviation writing.
- cGMP / cGDP.
- Strong scientific and technical acumen including technical writing skills.
- BS in Bio / Chem Science / Engineering or related field. Immunology education preferred.
- MSAT Technical Writer, Cell Therapy Vector Support ,Support, Manufacturing Science and Technology (MSAT).
- The focus of the MSAT Technical Writer is to investigate and write root cause analyses for non-conformance events during the manufacturing of cell therapy vector..
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.
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