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Quality Batch Release Specialist


Phillips-Medisize, a Molex Company, is seeking a Quality Batch Release Specialist to support our St. Croix Meadows facility in Hudson, WI. This role will be responsible for batch record review and disposition of medical device and/or pharmaceutical finished products and all associated component materials; and assuring that all associated deviations, Investigations and CAPA’s have been completed. The successful candidate will be a detail-oriented, critical thinker that has the ability to prioritize and make decisions; have strong written, verbal and interpersonal communication skills; be a leader that maintains confidentiality; has the ability to work with all levels of the organizations; customer focus; and the ability to work independently and as a part of a team.

What You Will Do In Your Role

  • Perform final batch record review and disposition of finished medical device and pharmaceutical products
  • Assure deviations are appropriately investigated, documented, and completed within required timelines
  • Execute final review and release activities to meet internal and external customer needs
  • Resolve batch concerns and questions directly with customers
  • Complete the date collection for annual product reviews
  • Lead and participate in quality improvement team activities
  • Prepare and provide information for inclusion in monthly quality metric reports
  • Provide guidance to functional groups in best practices for completion and review of GMP documentation
  • Appropriately catalog and store all finished product records
  • Manage records and retains area for compliance
  • Participate in audits (as needed) as well as other duties as assigned

The Experience You Will Bring


  • High School Diploma or GED
  • 2+ years of experience within manufacturing
  • Experience working in Microsoft Outlook (creating email correspondence), Word (document creation & editing), and Excel (formatting cells)

What Will Put You Ahead

  • Experience with GMPs Regulations (820, 210/211, EU)
  • Experience with quality tools, such as root cause analysis
  • Experience with SAP

Salary and Benefits Commensurate with Experience.
Equal Opportunity Employer.
Except where prohibited by state law, all offers of employment are conditioned upon successfully passing a drug test.

This employer uses E-Verify. Please visit the following website for additional information:www.kochcareers.com/doc/Everify.pdf

This role is not eligible for VISA sponsorship

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