JVT Advisors

QA Associate

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Location: Durham, North Carolina 02142
Employment Type: Contract

Job Description

Contract Length:  6 months

Job Summary:  The primary responsibilities of the QA Associate I in the Quality Systems team include, but are not limited to, performing review of documents for compliance to applicable regulatory and corporate guidance documents, and consistency with business source documentation. In addition, this person will be responsible for the timely and accurate issuance of documents and records (BPRs, SLRs, Labels, and Logbooks) required to support internal site operations for the Drug Substance and Drug Product sites.

Responsibilities:

  • Support the generation of metrics, revising/authoring GMP procedures, assist in the preparation and performance of regulatory inspections, develop and perform GxP Quality systems related training, review changes to existing Quality Systems and GMP processes, identify gaps in existing Quality systems and propose solutions to site management.
  • Contribute to oversight of quality systems, and maintain GMP activities.
  • Issue Batch Production Records, Solution Lot Records, Labels, and Logbooks.
  • Review and approve site-specific GMP documents and records which includes, document creation, revision, review, change control guidance/review/approval, document issuance oversight, and document maintenance.

Chintan “Calvin” Raval

Vendor Operations Manager/Senior Recruiter

As the vendor manager for the Contract Recruiting team, Chintan is responsible for contract negotiation, continuing to expand relationships with IT service providers, and functional reporting including metrics for billability, operational issues, and investigated root causes.

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