Quality Control Scientist job in Boston, USA

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First Name*

Last Name*

Email*

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First Name*

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Phone Number*

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Are you an employer or a jobseeker?*

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Job type: Permanent

Discipline: Analytical Chemistry, Biochemistry, Pharmacology

Location: United States

This vacancy has now expired. Please see similar roles below...

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.

#LI-BC1

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