Quality Control Scientist

Proclinical is currently recruiting for a Quality Control Scientist with a pharmaceutical company located in Boston, MA.

Job Description:

• Represent Quality Control in a highly matrixed, cross functional environment
• Support establishment of Quality Control systems to support commercialization activities
• Support the stability program through tracking of stability pulls, internal data summaries, and preparing data for statistical and preparing data for statistical analysis.
• Support activities to streamline data review, stability data reporting, stability protocols and reports across external labs.
• Review / approve method validation protocols, reports, as applicable for INT, DS and DP
• Data review for CTM batch release (including API, drug product data review).
• Work with internal stakeholders, including QA and Technical Operations, to ensure timely sharing of information and seek out input from these stakeholders as required.
• Provide support for OOS/OOT investigations, as required.
• Reviewing and writing CMC sections to support regulatory submissions.

Skills and Requirements:

• A BS Degree in Chemistry, Biochemistry, Biology or a related discipline with 7+ years of relevant industry experience
• Experience in a GMP laboratory including QC drug substance and drug product stability, preferably small molecule experience
• Experience in OOS/OOT resolution, root cause analysis tools, and monitoring effectiveness of CAPAs Good working knowledge of ICH stability guidelines
• Experience with analytical testing techniques including HPLC, GC, KF, dissolution

If you are having difficulty in applying or if you have any questions, please contact Bri Copeland at 267-297-3280.

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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