Technical Writer in Bedford, NH at Apex Life Sciences

Date Posted: 2/14/2018

Job Snapshot

Job Description


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!


Responsibilities:

  • 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. 


Qualifications: 

  • 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:

  1. Please send your resume to jpetillo@apexlifesciences.com
  2. Put 'Technical Writer- NH' in the subject line!