Catalent, Inc.
pharmaceutical
QCChemistI
“QC Chemist I at Catalent, Inc.. Skills: analytical techniques, cGMP, ICH guidance, FDA guidance. performing various analytical techniques. common standard lab practices”
Industry & Context.
Out of Specification investigations
100% on-site (San Diego), Individual needs to be accessible to lab and office staff and able to use required office equipment, Specific vision requirements include reading of written documents and use of computer monitor screen frequently
What They're Looking For.
Must Have
Bachelors of Science in a scientific discipline (Chemistry or biochemistry preferred), Applicable laboratory experience, some GMP exposure preferred
Nice to Have
PXRD, DSC, FT-IR, TGA, SEM
What You'll Do.
performing various analytical techniques
common standard lab practices
assess the quality of pharmaceutical products
Independent execution of various standard laboratory techniques
Execution of more advanced analytical techniques with assistance
Independent preparation of samples
instrument set-up and breakdown
Independent preparation of data packets and creation of stability data sheets and Certificates of Analysis
Assisted participation in Out of Specification investigations and the documentation of analytical deviations
Understand and apply ICH and FDA guidance
Communicate with clients and intra-company personnel
notification of OOS/OOT
How You'll Work.
Team & Collaboration
Communicate with clients and intra-company personnel; Assisted participation in Out of Specification investigations and the documentation of analytical deviations along with Qualified Investigators and management
Communication Scope
Communicate with clients and intra-company personnel; delivery of data; notification of OOS/OOT
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