Thermo Fisher Scientific QC Data Reviewer in Bedford, Massachusetts
When you are 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.
The BioProduction Division is one of the fastest growing businesses in the company, supporting developers and manufacturers of biological-based therapeutics and vaccines. With our portfolio of best-in-class products that span the bioprocessing workflow from discovery through large-scale commercial production, our business is driving performance in bioprocessing through collaboration with our customers .
How will you make an impact?
This newly created position will collaborate with the QC team to review data and provide recommendations. You'll also work on continuous improvement initiatives within the growing Quality organization of the Bedford, MA facility.
What at will you do?
Supporting the Quality Organization, the QC Data Reviewer will:
Solely responsible for Data Review of In-Process samples, Release samples, and Raw Materials for data generated on HPLC, RI, FTIR, Porosimeter, and Particle size analysis run on the Coulter.
Create Deviations and OOS Reports, support root cause analysis, and CAPA as requested.
Assist in writing and reviewing new and existing SOP's.
Participate in and support Continuous Improvement projects.
How will you get here?
Education and Experience
- Minimum of B.S. Degree in scientific discipline with 3+ years of experience in biotech, clinical, or equivalent QC laboratory environment.
Knowledge, Skills, Abilities
Working knowledge of AKTA/Unicorn HPLC system and/or experience with various HPLC techniques such as SEC, Ion Exchange, and Reverse Phase.
Ability to work independently or as part of a team.
Be able to interact with other analysts when corrections are identified as part of the data review process.
Excellent inter-personal, communication and organizational skills with good attention to detail.
Working knowledge of immunoassays including experience with plate readers strongly preferred.
Must be able to work safely with chemicals, biologics, and hazardous materials.
At Thermo Fisher Scientific, each one of our 75,000 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.
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.
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