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Technical Writer

Posted 9 days ago

  • Expiry Date: 18 December 2021

​​Job Description:

  • Local Candidates Strongly Preferred

  • Has potential to be remote, but need local candidates

  • MSAT Technical Writer I, Cell Therapy 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:

  • 1+ years relevant experience in drug product biopharmaceutical or equivalent industry

  • cGMP/cGDP

  • Ability to prioritize multiple investigations in order to meet deadlines

  • Strong scientific and technical acumen including technical writing skills

Preferred experience:

  • Deviation writing

  • 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

About ASK:ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities

ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.