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QA Batch Record Auditor - United States  

Company managed [?] Still accepting applications

Posted on : 08 May 2017

Project Description

Job Description 
  • 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. 



Major Duties/Responsibilities:  
  • 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.   


Required Experience 
 
  • 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.  



Preferred Experience 
  • 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.