Technical Writer in Fremont, CA at Apex Life Sciences

Date Posted: 3/3/2018

Job Snapshot

Job Description

Apex Life Sciences is looking for a highly motivated Technical Writer to work with our client, a major biotech company in Fremont, CA.

Job Responsibilities:

  • Develop design control documentation, including Design and Development Plans, Development Reports, Test Method and Process Validation Protocols, FMEAs.
  • Develop and update Manufacturing procedures, QC procedures, and other documents from a Device Master Record (DMR)
  • Manage document change control
  • Regularly interact with subject matter experts and attend project team meetings
  • Manage documentation review and approval: Proactively solicit and rapidly incorporate feedback from other functions (QA, RA, R&D, MFG, etc).
  • Maintain integrity of documents to comply with and be incorporated into the company’s quality procedures. High quality, well formatted, clear documentation following GDP (good documentation practices) is mandatory.
  • Work with minimal supervision and manage time effectively
  • Deliver under tight deadlines
  • Identify and communicate risks to project deadlines in advance
  • Adapt to changes in project priorities
  • Any other duties as required for the role

Minimum Requirements/Qualifications:

  • M.S. degree in a life science (biomedical) or quality field.
  • A minimum of 3 years of experience supporting IVD products, including writing Design Control documentation and DMR documentation.
  • Experience in Molecular Diagnostics preferred
  • Advanced knowledge of Microsoft Office (Word, Excel, PowerPoint, Outlook, etc.).
  • Strong experience in Design Control, ISO 13485, and 21 CFR Part 820 Quality Systems Regulation.
  • Quick learner, thorough understanding of presented technical/scientific content.
  • Ability to write clearly, concisely, accurately, and quickly under tight deadlines.
  • Keen attention to detail and high regard for quality.
  • Experience working in a self-driven, performance/results oriented, fast paced matrixed environment.
  • Willingness to take on new challenges.
  • Able to adapt to changing needs caused by time, budget, or other constraints.
  • Excellent problem solving skills, including issue resolution.
  • Must be highly collaborative; Have the ability to work within a diverse team and contribute to a supportive, positive work environment both within the team and in the greater community