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Thermo Fisher Scientific Technical Writer II in Saint Louis, Missouri

How will you make an impact?

The Technical Writer position requires the coordination and writing of cGMP manufacturing batch records for clients. In addition, the responsibilities will include addressing client comments and revisions to the documents, supported by subject matter experts. Additional responsibilities will include Standard Operating Procedure (SOP) updates to ensure agreement with the manufacturing batch records. The Technical Writer is expected to possess a scientific background, preferably in biologics, solid organizational skills, and attention to detail.

What will you do?

  • Responsible for the translation of processes from the Process Engineering and Process Development groups into batch production records to support cGMP manufacturing.

  • Respond to internal and client comments and proactively work with SMEs to ensure comments are incorporated.

  • Continually review existing templates of batch production records to generate products of consistent quality.

  • Work with Quality Assurance, Operations teams, and Process Engineers to optimize templates as required.

  • Revise SOPs as needed to optimize processing and ensure alignment with current practices and processes.

  • Collaborate cross-functionally to ensure the success of the processes and programs as needed

  • Partner with other areas to ensure good quality and cGMP practices with process changes

  • Live the Thermo Fisher Scientific 4Is values every day. Be proactive.

How will you get here?

Education

Bachelor's degree in STEM discipline required

Experience

  • 2-5 years of industry experience, preferably in a cGMP environment, experience writing SOP and/or pharmaceutical batch record documents is preferred.

  • Proven success working in cross functional teams, ability to work collaboratively, and provide pro-active communication is required.

  • Quality and/or Financial software (SAP, Documentum, SuccessFactors, etc) skills preferred

Knowledge, Skills, Abilities

  • Excellent understanding of cGMP and other regulatory requirements in the operation of cleanrooms

  • Understanding of cGMP quality systems (e.g. change management and driving GDP within all documentation and records).

  • Ability to work both independently and in a team environment.

  • Ability to self-motivate, prioritize work and time.

  • Organized, efficient, and results oriented

  • Ability to follow-up on commitments and detail oriented.

  • Expert in oral and written communication (verbal and written in English), as well as social skills.

  • Computer literate with Microsoft Office tools, including report writing and graphing.

Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.

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