Technical Writer
2 weeks ago
Position Overview:
The focus is to investigate and write root cause analyses for non-conformance events during the manufacturing of cell therapy vector.. 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 reportsResponsibilities: 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
Required Qualifications: BS 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
Preferred Experience: 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
Pay Rate: $57.23/hr.
If hired, you will enjoy the following Eclaro Benefits: k Retirement Savings Plan administered by Merrill Lynch Commuter Check Pretax Commuter Benefits Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro
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