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