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Technical Writer

Company: Tech Observer
Location: New York
Posted on: February 25, 2021

Job Description:

Title : Technical Writer - GMP Type : Contract ( 3 - 6 Months +) Location: East Hanover NJ Duties: Coordinates and develops with Analytical & Process Science, Engineering and QA Teams qualification projects and plans and identifies the "critical to quality parameters impacting qualification activities. Supports preparing Qualification Master Plans, Risk and Impact Assessments, Protocols and Summary Reports and coordinates review and approvals of the documents Authors/reviews/updates/assists in developing departmental standard operating procedures (SOPs) and qualification documents/programs. Ensures that all activities are in compliance with cGMP, Health Authority regulations and the Client Policies. Qualification and Required skills: Knowledge of bio-pharmaceutical unit operations for production of cell therapies is preferred. 5+ years of Pharmaceutical industry experience and 5 + years of Facilities, Utilities, Equipment and Analytical Instruments. 3+ years of experience in a GMP environment or relevant GMP documentation experience. Education: BS degree in Scientific discipline

Keywords: Tech Observer, New York , Technical Writer, Engineering , New York, New York

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