Technical writer

MSAT Technical WriterThe 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 modesLearns complex cell biology concepts & applies them to root cause investigationsWorks independently and with Process Engineer(s) to understand different failure modesWorks with GMP Quality Systems to deliver completed Root Cause Analysis investigation reportsEducation:BS in Bio/Chem Science/Engineering or related fieldImmunology education preferredExperience:Required experience: 3+ years relevant experience in drug product biopharmaceutical or equivalent industryDeviation writingcGMP/cGDPAbility to prioritize multiple investigations in order to meet deadlinesStrong scientific and technical acumen including technical writing skillsPreferred experience:Quality management systemComplex problem-solving skills, including root cause investigationCross-functional collaboration with engineering and quality partnersBiologics or cell therapy manufacturingTrained in Kepner Tregoe Problem SolvingDuties and Responsibilities:Facilitates deviation closure through working with quality partners and site quality systemsAnalyzes and summarizes manufacturing data to support root cause investigationsAnalyzes and summarizes characterization data to write root cause investigationsUtilizes root cause analysis tools such as fishbone, 6Ms, Five Whys, to identify root causeWrites technical and thorough investigation reports