Quality Control Analyst

Proclinical is currently recruiting for a Quality Control Analyst with a biopharmaceutical company located in Cambridge, MA. Successful candidate will be responsible for routine testing of incoming raw materials and product (e.g. in-process samples, release, etc.) in support of GMP manufacturing. Demonstrated technical ability in QC analytical, ability to interpret compendia (USP, Ph. EUR, JP, etc.), and troubleshooting experience are required; microbiological methodology understanding

Job Responsibilities:

• Demonstrated technical ability in QC analytical, ability to interpret compendia (USP, Ph. EUR, JP, etc.).
• This position requires flexibility with changing priorities.
• Domestic travel between sites is required.
• 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 sites.
• Support operational systems (e.g. equipment maintenance, reagent preparation, forms control, etc.).
• 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.
• Contributes to Quality Control department goals and objectives.

Skills and Requirements:

• BS in applicable science field.
• 0 - 2 years of experience in a GMP laboratory setting.
• Experience with compendia (USP, Ph. EUR, and JP).
• Familiarity with compendial assays, wet chemistry techniques, HPLC/UPLC, GC, Karl Fisher, UV-Vis and FTIR; microbiological methodology understanding is desirable.
• Experience with aseptic techniques and gowning is desirable.
• Data Trending and control chart interpretation is desirable.
• Ensure compliant laboratory function and continuous state of inspection readiness
• Ensure continuous supply of raw materials for use in manufacturing.
• Ensure production support within cycle times to meet on-time delivery of OnPattro to patients.

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 Zachary Hines at (+1) 215-531-6914 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.

#LI-ZH1
#Compliance/Quality