Technical Writer II, Technical Operations Team 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.
Location/Division Specific Information St. Louis, MO
How you will make an impact! This position requires the coordination and writing of cGMP documents for clients. In addition, addressing client comments and revisions to the documents, supported by subject matter authorities. Additional responsibilities will include Standard Operating Procedure (SOP) updates to ensure agreement with the manufacturing batch records. The Technical Writer is encouraged to possess a scientific background, preferably in biologics, solid organizational skills, and attention to detail. We work as a team and support each other in everything we do.
A Day in the Life. Own Corrective And Preventive Action's (CAPA) and work with your team and manager to ensure closure by specified due dates. Complete Action Items (AI) associated with Change Controls (CC), working with team members when required. Assist in closing process deviations by required due date. Assist in populating and maintaining CAPA document tracker and updating Smartsheet dashboard when needed. Review completed documents and log comments in to document tracker. Work with Process Engineering to ensure logged comments are addressed during revision cycle. Review process documentation (i.e. Master Batch Records (MBR's) for grammatical errors, technical style, and general readability. Also be trained on technical review of process documents. Ensure reviews are completed before needed on the manufacturing floor. Basic knowledge of processing equipment and operations. Assist in completing document (SOPs, Job Aid's and Form's) improvement opportunities identified from the "Document Improvement Tracker" and 1:1 discussions with cross functional team members. Work with SMEs to deliver accurate documents that ensures successful execution and respond to internal comments during document review process. Assist in FDA remediation activities when required. Assist in maintaining department Key Process Indicators and metrics. Present metrics as needed. Work with manager to identify and develop countermeasures as needed. Assist in error proofing activities. Attend and participate in Team Huddle. Attend monthly safety meeting on rotating schedule with other team members. Attend Practical Process Improvement (PPI) Power User training and receive certification. PPI Skills are a plus. Ability to stand for long periods of time and gown into manufacturing areas to observe manufacturing process. Live the Thermo Fisher Scientific 4Is values every day. Be proactive. How will you get here? Education Bachelor's degree in STEM from a four-year college or university Equivalent combinations of education, training, and meaningful work experience may be considered. Experience 2+ years of experience, preferably in a cGMP environment Knowledge, Skills, Abilities Excellent understanding of cGMP and other regulatory requirements in the operation of cleanrooms Experience in quality systems (e.g. eDMS and Trackwise). 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. Good oral and written communication (verbal and written in English), as well as interpersonal skills. Computer literate with Microsoft Office tools, including report writing and graphing. Knowledge of Smartsheet is a plus. Quality and/or Financial software (SAP, Documentum, SuccessFactors, etc). Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
At Thermo Fisher Scientific, each one of our 100,000+ 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.
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