Technical writerTechDigital Group • Libertyville, IL, US
Technical writer
TechDigital Group • Libertyville, IL, US
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job_description.job_card.job_descriptionBS in Bio / Chem Science / Engineering or related field Immunology education preferred 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 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
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 :
Experience :
Required experience :
Preferred experience :
Duties and Responsibilities :
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Technical Writer • Libertyville, IL, US
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