Apex Systems Inc
Apex Life Sciences has an exciting opportunity for a Technical Writer
near Manchester, NH!
The successful candidate will play a significant role on cross-functional teams to deliver technical documentation (production batch records, protocols, and procedures). We are looking for individuals with prior technical writing experience
that are interested in working in a fast-paced, dynamic environment!
Conduct complex document generation and revision including batch production records and manufacturing procedures.
Technical writing of protocols, standard operating procedures and GMP batch records (new and revisions) based on project scope and client processes.
Perform review of manufacturing documentation generated by the receiving unit (manufacturing records, SOPs, etc.).
Support and develop consistent manufacturing standards for controlled documents used within cGMP manufacturing
Management of document review and approval processes
Learn client processes and act as a technical liaison with the client
Assist with supporting Engineers and Manufacturing Operation leads in generation of project documentation (i.e. material control procedures, training manuals).
Compose quality system reports ( unplanned deviation investigations, CAPA support
) as requested
Review batch records for compliance and improvement as required, focusing specifically on: processing parameters, materials, equipment use.
AS in a Life Science/Technical Field or BS/BA
Process development or production experience preferred with basic understanding of (Chemistry, Math and laboratory sciences)
Demonstrable knowledge of GLP/GMP
Minimum of 2 years’ experience with technical/scientific writing.
Experience in a GMP industry in a manufacturing documentation support area
For IMMEDIATE CONSIDERATION:
Please send your resume to [Click Here to Email Your Resumé]
Put 'Technical Writer- NH' in the subject line!
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Apex Systems Inc
Website : https://www.apexlifesciences.com/
Apex Life Sciences is a division of the 3rd largest clinical/scientific staffing and services firm in the U.S. We match top scientific, engineering, and clinical research professionals at all career levels for contract, contract-to-hire, and direct hire opportunities.