Purpose of Position:
The position involves the performing of routine and non-routine analyses of raw materials, in-process materials and finished products in accordance with cGMP guidelines. The appropriately trained individual may provide training and guidance to other QC Analysts. The individual troubleshoots problems associated with methods and instruments resolving them where possible or seeking guidance/authorization where required.
Key Responsibilities:
Understands the importance and priority of EHS and takes personal responsibility for their own safety; looks out for the safety of colleagues and avoidance of all incidents; willingly engages in and embraces activities to improve EHS performance in the working environment.
Test and analyze samples in a timely manner in support of project plans in accordance to cGMP guidelines
Review analytical data for compliance with specifications and cGMP guidelines
Assist in development of experimental procedures and protocols
Develop/revise documentation such as SOP, testing procedures and material specifications
Provide training and guidance to other analysts
Job Knowledge Required:
BS/MS in chemistry, biology or related discipline
4-10+ years experience as a QC analyst/chemist in a GMP environment
HPLC experience is required
Experience and familiarity with analytical testing equipment and methodology including Karl Fischer, Spectrophotometry (UV/VIS, IR, NMR), and possibly LCMS.
Equal Opportunity Employer: