Quality Control Specialist

Proclinical is currently recruiting for a Quality Control Specialist with a biopharmaceutical company located in Raynham, MA. Successful candidate will be responsible for routine testing of incoming raw materials and product (e.g. in-process samples, release, etc.)

Job Responsibilities:

• Support operational systems (e.g. equipment maintenance, reagent preparation, forms control, etc.).
• Performance of QC raw material, in-process, and bulk drug product testing, as well as support of testing/review of data with/from contract testing laboratories (e.g. compendial methods, HPLC, fluorescence assays, particle sizing, bioburden, and endotoxin, etc).
• Participate in method transfer to/from contract laboratories.
• Participate in method and equipment qualification and validation at both Norton and Alewife sites.
• Support implementation of programs (e.g. evaluation/implementation of compendial testing).
• Author technical documentation (e.g. SOPs) with guidance, as needed.
• Train on all relevant procedures, as appropriate.
• Troubleshoot routine problems related to laboratory procedures, assay performance, instrumentation, and data with input from direct manager; provide recommendations to non-routine issues.
• Collaborate with other internal departments efficiently and effectively (e.g. Manufacturing, Warehousing, Supply Chain, Facilities, QA, etc.)
• Train on all relevant procedures, as appropriate.
• Attend group and department meetings.
• Contribute to Quality Control department goals and objectives.

Skills and Requirements:

• BS in applicable science field.
• 2-4 years of experience in a GMP laboratory setting.
• Experience with compendia (USP, Ph. EUR, and JP).
• Working knowledge of compendia testing (USP, Ph. EUR, JP, etc.) wet chemistry techniques and analytical analysis (HPLC,GC,FTIR, KF, etc.)
• Experience performing compendial assays, wet chemistry techniques, HPLC/UPLC, GC, Karl Fisher, UV-Vis and FTIR; microbiological methodology understanding is desirable.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Mary Jacobs at (+1) 312-291-4181 or upload your resume on our website - www.proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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