Tunnell Consulting

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QA Auditor ( Batch Record Review)

at Tunnell Consulting

Posted: 10/9/2019
Job Reference #: 9160
Keywords: compliance

Job Description

The QA Batch Review Auditor is primarily responsible for the review and/or second verification of manufactured drug products for commercial distribution.  This position will be independent of the manufacturing review and must have an understanding of the implications of the work and knowledge of the context in which the work is being performed.  The QA Batch Review Auditor is responsible for conducting technical quality and compliance reviews in accordance with current Good Manufacturing Practices (CGMPs), FDA regulations and Standard Operating Procedures (SOPs).  The QA Batch Release Auditor makes sound decisions to ensure quality compliance and all procedural requirements are met for the approval/rejection of each lot.  This individual performs a variety of job functions in the Batch Release department, which includes auditing and/or second verification of manufactured drug products for commercial distribution.  This position may also help with the printing and issuance of batch records to production. 

 

• Experience in quality reviews of manufacturing and packaging batch records for bulk and finished packaged product for final disposition of lots
• Ability to review approved manufacturing and packaging investigations/deviations to determine final QA disposiiton
• Attentive to detail, able to recognize critical attributes, steps and functions relating to manufacturing processes and/or laboratory activities
• Knowledgeable of cGMPs and application of good documentation practices within pharmaceutical industry