QA Batch Record Auditor - United States
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- Our company is a leading global healthcare supplier that develops, manufactures and distributes over-the-counter (OTC) and prescription (Rx) pharmaceuticals, nutritional products, and active pharmaceutical ingredients (API).
- The company is the world's largest manufacturer of OTC pharmaceutical products for the store brand market and an industry leader in pharmaceutical technologies.
- Our company is looking for a Batch Record Auditor to their Quality Assurance team.
- The Batch Record Auditor will be responsible for reviewing batch records and resolving non-routine exceptions and accompanying paperwork to assure that batches were produced in compliance with cGMP’s and to assure that the product meets current acceptable specifications.
- Review batch records to ensure that batches are manufactured and/or packaged according to approved SOP’s.
- Assure that specified sampling and testing is complete, acceptable, and accounted for prior to batch disposition, and that cGMP errors are resolved and quality incident investigations closed out.
- Verify SAP batch information is accurate, and correct if needed.
- Verify accuracy of SAP inventory, and perform split batch transactions when required.
- Perform batch releases in SAP and file batch records.
- Work closely with internal, as well as sub-contract manufacturing Production, Packaging, QC and QA personnel to address production and testing concerns.
- Follow cGMP’s, SOP’s and Work Instructions.
- Performing quality incident investigations.
- Other duties as assigned.
A successful candidate will have:
- Ability to work independently and/or with minimum supervision against multiple deadlines.
- Excellent oral and written communication skills, and strong interpersonal skills.
- Strong attention to detail.
- Strong analytical skills.
- Excellent multi-tasking skills and flexibility to handle changing priorities.
- High school diploma or GED, advanced education preferred.
- Consideration may be given to those who hold 6 years of progressively responsible and relevant work experience.
- Minimum of 1 year experience in Quality and Operations.
- Minimum of 3 years experience working in FDA regulated industry.
- Possess an understanding of and ability to apply cGMP’s. Must be able to recognize variances from cGMP’s.
- Thorough knowledge of SOPs and be able to provide clear direction and interpretation to staff in multiple areas.
- Thoroughly understand equipment operation and manufacturing/packaging processes.
- Demonstrates a thorough working understanding of the interactions of complex business and compliance practices and requirements.