Intertwined

QA Batch Record Review Specialist

Full Time
Baltimore, MD, USA
Description

The Denzel Group, an award-winning search firm, has been chosen to work with an industry leader in Baltimore on their quest for a talented QA Batch Record Review Specialist. In this role you will manage records relevant to the review and release of Batch Records for the cGMP operations, as well as assist with process improvements.


Responsibilities

  • Coordinate batch record review and approval process.

  • Review GMP documents such as:Executed batch records.
    Analytical Testing Data.
    Microbial and Environmental Monitoring Data.
    WFI testing data.
    Equipment Data.
    Logbooks.

  • Execute SAP Transactions.

  • Review/revise SOPs.

  • Initiate non-conformance investigations.

  • Compile and report performance metrics for Batch Review and Release, and support continuous improvement.

Requirements
  • BS degree in Chemistry/Biology or related discipline.

  • 6+ years’ related GMP experience involving batch record and documentation review, investigations, and writing/revising SOPs.


To apply please email your application to mschroeder@thedenzelgroup.com


Batch Record review, release, QA, quality assurance, QC, quality control, investigation, deviation, GMP.


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