Catalent Biologics
Biologics
Scientist-QualityControl,DataReview
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Scientist - Quality Control, Data Review at Catalent Biologics. Skills: Quality Control, Data Review, cGMP. Review analytical testing. Review microbiological testing”
What You'll Achieve.
Assure quality of laboratory data; Assure quality of reports; Assure compliance with analytical methods; Assure compliance with GLP; Assure compliance with GMP; Assure compliance with client criteria
Industry & Context.
What They're Looking For.
Must Have
M. S. /M. A. in Biotechnology or related field, B. S. /B. A. in Biotechnology or related field with 3 years experience, Associates Degree/Certificate/Diploma in laboratory science with 4 years experience, Knowledge of chromatography, Knowledge of Standard Operating Procedures, Knowledge of FDA regulations, Familiar with cGMP documentation practices
Nice to Have
> 3 years of QC lab experience, HPLC experience, SDS-PAGE experience, Western Blot experience, cIEF experience, ELISA experience, Microbiology testing experience
What You'll Do.
Review analytical testing
Review microbiological testing
Verify analytical data
Verify microbiological data
Provide feedback for corrections
How You'll Work.
Team & Collaboration
Team meetings
Communication Scope
Provide feedback
Full Job Description
**Scientist I - Quality Control, Data Review** **Position Summary:** * **Work Schedule:** M-F 8am-5pm * 100% on-site Catalent Biologics is a fast growing business within Catalent Pharma Solutions focused on providing innovative technologies and solutions to help more and better biologic treatments get to patients. The business includes our proprietary GPEx cell line engineering platform, our new state-of-the-art biomanufacturing facility in Madison, WI, and our market leading biologics analytical services in Kansas City, MO and Research Triangle Park, NC, as well as SMARTag Antibody Drug Conjugate technology in Emeryville, CA. Leveraging our growing differentiated technology portfolio, world class manufacturing capability, and other integrated services across the Catalent network, Catalent Biologics is positioned to drive significant growth for Catalent. **Catalent Pharma Solutions in Madison, WI is hiring a Scientist I - Quality Control, Data Review.** This position requires a variety of skills necessary for biotech company operations. The basic purpose of the QC Reviewer is to assure the quality of laboratory data and reports. This is accomplished by reviewing chromatographic data and related notebooks as specified by Standard Operating Procedures. The objective of the QC review process is to evaluate chromatographic data to assure compliance with analytical methods, FDA's Good Laboratory Practices and/or Good Manufacturing Practices and client criteria. **The Role:** * Accurately review analytical and/or microbiological testing following SOPs. * Reviews and verifies analytical and/or microbiological data and reports, ensuring accuracy and consistency. * Provide clear feedback for corrections needed. * Actively participates in team meetings. * Other duties as assigned. * All other duties as assigned. **The Candidate:** * M.S./M.A. in Biotechnology, or related field, with no prior experience; or * B.S./B.A. in Biotechnology, or related field, with minimum of 3 year
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