Quality - Technical writer

MSAT Technical Writer, Cell Therapy Vector Engineering Support (CTES), Manufacturing Science and Technology (MSAT)

The focus of the MSAT Technical Writer is to investigate and write root cause analyses of in-process and end-of-process testing results outside of the specified range during and after drug product manufacturing. 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 preferred

Experience :

Required 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

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

Duties and 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 Kepner Tregoe Problem Solving to identify root cause

Writes technical and thorough investigation reports

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