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GMP Technical Writer

Company: Eurofins USA
Location: Bothell
Posted on: May 6, 2021

Job Description:

Company Description Consider joining Eurofins Lancaster Laboratories where people are the most important element in our chemistry. Celebrating 55 years of service, Lancaster Laboratories is a leading contract lab providing testing and research services in the environmental, pharmaceutical, and biopharmaceutical sciences to clients worldwide. Eurofins Lancaster Laboratories, a nationally recognized laboratory, is searching for an experienced GMP Technical Writer to join our Professional Scientific Services group in Bothell, WA. Job Description GMP Technical Writer responsibilities include, but are not limited to, the following:

  • Lead investigations and bring them to a resolution with minimal direct supervision
  • Perform root cause analysis on deviations, serving as primary author of deviation reports, utilizing technical writing for the educated but uninformed reader, translating moderate to complex scientific events into a brief and cohesive report as a finished product and address comments from both internal and external stakeholders on the final report
  • Gather Data from various sources across the site, assess events for impact to product quality, perform Trending Analysis, and perform Risk Assessments
  • Work closely with Departments, Quality Assurance, and support groups to develop appropriate CAPAs
  • Initiate appropriate corrective action/preventative action (CAPA) to prevent deviation recurrence
  • Act as an area/department representative in deviation discussions, coordinating activity and proposals with functional area approvers for both deviations and CAPAs
  • Meeting Facilitation and participation, aligning internal review team and area subject matter experts on an agreed to investigational path forward
  • Utilize conflict resolution, problem solving in a cross-functional setting
  • Management of multiple projects and concurrent timelineswhileadhering to standard timelines, and escalating actions appropriately for resolution in a timely manner The ideal candidate would possess :
    • Proficiency with technical writing in cGMP or FDA regulated manufacturing environment
    • Ability to work in a fast paced environment and manage multiple projects and objectives for on-time event closure
    • Must work well on a team and be able to troubleshoot and problem solve in a cross-functional team setting
    • Must be proactive, action oriented, and adapt to change
    • Able to identify and flag risks in a timely manner to keep deliverables on track
    • Strong written and verbal communication skills
    • Ability to read and comprehend complex subjects
    • Strong typing and computer skills, including efficiency using Microsoft Office Suite (Word, Excel, PowerPoint), and familiarity with cGMP quality systems
    • Ability to understand and apply GMP regulations as they relate to pharmaceutical manufacturing Qualifications
      • BS in scientific discipline such as Biochemistry, Chemistry, Biology or related discipline
      • Minimum of 2+ years' experience conducting investigation and root cause analysis in a pharmaceutical or FDA/GMP environment required
      • Experience performing Root Cause Analysis using tools/methodologies such as 5 Why, 6M, Fishbone Diagrams, Cause Mapping, etc.
      • Experience with GMP compliance in clinical/commercial manufacturing environment is required
      • Experience with quality management software (Mastercontrol, Trackwise, etc.) is preferred
      • Experience with asset management software (Blue Mountain, Maximo, etc) is preferred
      • Authorization to work in the United States indefinitely without restriction or sponsorship Additional Information Position is full-time, working Monday through Friday, 8:00 a.m. - 5:30 p.m., with overtime as needed. Candidates currently living within a commutable distance of Bothell, WA are encouraged to apply. What we offer:
        • Comprehensive medical coverage, with dental and vision options
        • Life and disability insurance
        • 401(k) with company match
        • Paid holidays and vacationEurofins Lancaster Laboratories Professional Scientific Services--(PSS) is a global, award-winning insourcing solution that places our people at our clients' site dedicated to running and managing laboratory services while eliminating headcount, co-employment and project-management worries. We infuse our 55-year track record of scientific and laboratory operations expertise, as well as HR and great place to work best practices, to recruit, hire, train and manage highly qualified scientists to perform laboratory services using our client's quality systems and equipment. To learn more about Eurofins, please explore our website. Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.

Keywords: Eurofins USA, Seattle , GMP Technical Writer, IT / Software / Systems , Bothell, Washington

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