Thermo Fisher Scientific Scientist II (QC Technical Writer) in Saint Louis, Missouri
Job Title Scientist II (QC Technical Writer)
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
This position supports the QC Analytical team for our Biologics Division in St. Louis, MO.
How will you make an impact?
The Scientist II (QC Analytical Technical Writer) will be responsible for preparing new documents in the QC Analytical group as per ICH guidelines for Biopharmaceutical Drug Substance such as product specifications, Validation protocols/reports and Method transfer protocols/reports. The individual will also be responsible for creating/ revising standard operating procedures and test methods, as needed.
What will you do?
Work directly with QC Project lead, QC testing group and clients to address work and comments related to technical documents.
Authors and reviises analytical method validation and method transfer documents.
Authors and revises QC standard operating procedures and test methods, as needed.
Authors and revises QC data forms, specification documents, BOT, Certificate of Testing and all other pertinent technical documents for QC
Coordinate and communicate with QC project leads and/or management for status of project-related documents
Carries out duties in compliance with all local, state and federal regulations and guidelines including FDA, EPA and OSHA
Complies with all company and site policies and procedures. Reports any non-conformances. Initiates and/or leads resolution efforts for issues related to analytical documentation
Other job duties as assigned
How will you get here?
Bachelor's Degree in a Biological Science related field required and 5+ years related experience in biopharmaceutical or pharmaceutical industry.
At least two years as an analytical method technical writer, or a senior scientist (SME) in the lab performing analytical assays
Extensive knowledge of GMP regulations in cGMP manufacturing environment.
Working Knowledge of scientific principles for wide range of analytical techniques strongly preferred. HPLC and ELISA experience with large molecules is preferred.
Advanced knowledge of FDA guidance for industry for Analytical Procedures and Methods Validation for Drugs and Biologics
Knowledge, Skills, Abilities
Ability to understand customer requirements related to Quality control, including processes and equipment.
Outstanding technical writing skills.
Strong interpersonal skills including actively listening, conflict resolution and the ability to effectively influence diverse stakeholders for positive outcome.
Ability to build strong relationships with client while instilling trust and confidence
Highly organized with attention to detail
Knowledge of Qualification and Validation requirements for analytical methods
Working knowledge of cGMPs and Quality Control regulatory requirements
Experience with authoring documents for qualification/validation/transfer of QC assays/methodology.
Performs analytical and technical troubleshooting
Excellent communication skills
Ability to adapt to constantly evolving tasks and priorities
Routine use of MS Excel, MS PowerPoint, and MS Word is essential
At Thermo Fisher Scientific, each one of our 65,000 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.
Apply today! http://jobs.thermofisher.com
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.
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.