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Quality Control Specialist II

Company: Yoh, A Day & Zimmermann Company
Location: Cambridge
Posted on: August 4, 2022

Job Description:

Quality Control Specialist II

Cambridge, MA - Hybrid - 1 - 2 days onsite

6 month contract - perm potential


Currently seeking a Quality Control Specialist who is self-driven, can multi-task and is a strong team player. This successful candidate will manage and maintain the documents and quality records for late stage and commercial product specification of several therapeutic programs.

Experience needed for the role:

5+ years of experience in an industrial setting, preferably in a cGMP environment as it pertains to the biopharmaceutical industry
Contributes substantially to the interpretation of data and subsequent impact to methods/products.
Working knowledge of statistical analysis of data, lifecycle management of late-stage and commercial products, and commitment to data integrity. The successful candidate would have a good command of technical writing in English.
Prior experience with FDA, ICH, and JP guidelines as it pertains to drug substance and drug product specifications
Knowledge of regulatory processes in relation to filings
Strong collaborative, communication, and time management skills
Sound judgement and commitment to transparency and integrity

Responsibilities:

Responsible for lifecycle management of specifications and justification of specification reports.
Responsible for coordinating QC impact assessments as part of quality records (change controls, CAPAs, deviations, etc) for specifications.
Maintains ad hoc meetings with the Specification Review Board, a cross-functional team, to support the lifecycle of early (in partnership with Analytical Sciences), late, and commercial programs.

#IND-SPG
#MON-SPG
#CB-SPG

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Visit to contact us if you are an individual with a disability and require accommodation in the application process.

Keywords: Yoh, A Day & Zimmermann Company, Cambridge , Quality Control Specialist II, Other , Cambridge, Massachusetts

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