QC Manager - Job ID:4774

6 month + contract

 

Responsibilities:

·         QC Manager will perform initial evaluation of QC laboratory including operational execution and resources.

·         Identify, hire and manage QC staff.

·         Generate, review and revise QC GMP documentation (SOPs, protocols, technical reports, specifications, etc.).

·         Manage stability activities including maintenance of master stability protocols and individual study plans, set up of stability studies, and assist in writing of timely stability reports.

·         Investigate and resolve analytical test failures (OOS and atypical results).

·         Monitor contract lab activities to ensure compliance and timeliness of C of As and reports.

·         Summarize and report laboratory performance metrics.

·         Manage various projects at contract laboratories.

 

Qualifications:

·         BS or equivalent and 4+ year’s laboratory experience in the pharmaceutical industry in Quality Control as a manager.

·         Must have experience in the QC testing of pharmaceutical/biologic products in a GMP environment.

·         Strong technical knowledge of analytical methods for pharmaceutical products.

·         Solid understanding of Quality Control CMC requirements for NDA’s and other regulatory filings.

·         Strong working knowledge of GMP compliance.

·         Experience in managing contract testing laboratories.

 

Required Skills:  QC, management

 

Candidates must live local and be a US Citizen or Green Card Holder

Email resume to: jobs@cwsciences.com

Commonwealth Sciences is a professional recruiting firm specializing in Science, Engineering and Green Technologies. We unite industry professionals with exciting career opportunities by leveraging our technical expertise, advanced recruiting tools and years of staffing experience. CWS works with a variety of disciplines and levels from Research Associates to Scientists, Engineers, Managers and Directors. Our clients value the basic integrity, customer service and industry expertise that defines our organization.


Commonwealth Sciences, Inc.
http://www.cwsciences.com

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