Technical Writer I

at  Thermo Fisher Scientific

Fremont, California, USA - 94536

Start DateExpiry DateSalaryPosted OnExperienceSkillsTelecommuteSponsor Visa
Immediate16 Oct, 2021Not Specified16 Jun, 20211 year(s) or aboveManufacturing Processes,Numbers,Figures,Electronics,Excel,Access,Chemistry,Biology,Powerpoint,Biochemistry,Management System,Gmp,Communication Skills,Customer ServiceNoNo
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Description:

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.

EDUCATION

  • Associates degree in electronics or equivalent required.
  • BS degree in Chemistry, Biochemistry, Biology, or equivalent preferred.
  • Effective communication skills and the ability to collaborate with cross functional teams

Experience

  • 1+ years medical device or pharmaceutical experience ISO 13485, FDA QSRs, GMP or IVDs
  • Experience in using an electronic Document Management System as a Technical Writer.
  • Knowledge of PC based software such as Office 2010 Professional (Word, Excel, Access, and PowerPoint).
  • Proofreading and editing skills, and an aptitude for numbers and detail-oriented work requiring a high degree of accuracy.

Knowledge, Skills, Abilities

  • Excellent organization and detail oriented
  • Ability to prioritize own and other’s work and meet business productivity metrics.
  • Excellent customer service and listening skills.
  • Basic arithmetic skills including the ability to calculate figures and amounts and to interpret the data.
  • Ability to work independently with minimal guidance and as part of a team; establish priorities, manage multiple activities, and adjust to changing priorities in a dynamic, FDA regulated environment.
  • Strong attention to detail, and a thorough understanding of technical terminology and complex manufacturing processes.

At Thermo Fisher Scientific, each one of our 80,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer

Responsibilities:

  • Work cross-functionally with other teams to create or revise manufacturing procedures via change control procedure.
  • Work with department subject matter experts to improve documented processes
  • Help correct and document nonconformities when necessary
  • Develop, improve, implement, and validate manufacturing process within Filling, Packaging, and Labeling departments
  • Work closely with Process Validation and Quality Assurance teams to develop processes, procedures, and specifications.
  • Responsible for reviewing quality requirements and documentation related to manufacturing processes to ensure quality products are delivered.
  • Maintain strict compliance with ISO13485, cGMP, QSR and other applicable Quality Management System standards
  • Proof-read and provide feedback on documentation prepared by other departments
  • Assist with completion of CAPA investigations write-ups and action items
  • Additional tasks as assigned
  • Review and recommends revisions or changes in scope, format, and content to existing documentation. Maintain records and files of work and revisions
  • Create part numbers and Bill of Materials into the Material Resource Planning (MRP) software as required.
  • Organize large amounts of technical information utilizing Advanced MS Word and Excel functions as well as manage a large number of technical documents simultaneously.
  • Technically strong to work independently and collaborate with cross functional teams to identify appropriate content updates as required.
  • Participate in cross functional documentation projects as required.
  • Standardize and streamlines documents and documentation system in coordination with technical personnel and managers.
  • Keep department lead or manager updated on all issues.


REQUIREMENT SUMMARY

Min:1.0Max:6.0 year(s)

Pharmaceuticals

Pharma / Biotech / Healthcare / Medical / R&D

Content, Journalism, Clinical Pharmacy

BSc

Biology, Chemistry

Proficient

1

Fremont, CA, USA