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