Remote Document Specialist/Technical Writing (Quality Systems/SOPs) – RTP Pharma/1 Year Contract

Job Type: 
Professional Services
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Our client, an RTP-based pharmaceutical company, is actively recruiting for a highly skilled writer, with substantial experience drafting SOPs, Design Control documents and other required documents for FDA-regulated companies, to join its Quality and Operations team.

This is a contract role expected to last 1 year, possibly longer.  Compensation will be generous

If you or someone you know would be interested, we would be eager to connect with you.

Key Things to Note:

  • The company develops products that were recently classified by the FDA as Drug-Led Combination Products.  It is putting in place a Quality System that is compliant with the regulations of Design Control for Combination Products, which will require writing, rewriting and/or editing numerous SOPs.  This Writer will be instrumental in this effort. 
  • The focus of the role will be to generate, compile, review, and maintain documents to comply with regulations for Combination Products.  It will also involve circulating documents for review and approval.  We seek a writer who is also a skilled project manager.
  • This is a highly interactive role.  Seek candidate who enjoys collaboration.
  • The company is FDA-regulated and requires candidates with experience in cGXP environments.  Familiarity with writing SOPs in a lab-based setting will be valuable.
  • This is a Home-Based / Remote position. 

Selected Responsibilities:

  • Contribute to the generation of design control documents, such as Reports, Protocols, Risk Assessments, and Specifications, under the guidance of the supervisor.
  • Contribute to the authoring of Standard Operation Procedures for Design Control, under the guidance of the supervisor.
  • Create templates for use by other personnel.
  • Format documents and upload them into the Document Control system in compliance with governing SOPs.  Coordinate the review and approval of documents as needed.
  • Collect and register technical design control documents (such as drawings, specifications, reports) from internal sources and external vendors to compile a product’s Design History File in SharePoint.
  • Attend Design Control meetings to compile meeting minutes and track action items.

Targeted candidate will offer a related degree and 3+ years of experience working in the biotech or pharmaceutical industry with GMP procedures, including substantial experience in Technical Writing and/or Document Control. Some experience with design control documents would be a plus.

Other priorities include:

  • Experience with compiling, reviewing and maintaining quality system documents
  • Excellent written communication to review internal and external documents, and write SOPs
  • Excellent organizational skills and attention to detail.
  • Strong interpersonal communication and time management skills.
  • Ability to work within tight timelines and to adapt to changing priorities.

Finally, we seek a team player who will work exceedingly well in this emerging business setting; someone who is resourceful, focused, disciplined, congenial and collaborative.

This is an immediate need.  Please forward resume/CV for prompt consideration.