Key Responsibilities:

• Ensure release due report is accurate and updated.
• Monitor ECO’s, NCI’s and PPC’s to ensure all PRO’s are aware of holding release dates.
• Ensure communication with production daily so that corrections are resolved in a timely manner.
• Manage communication with affiliate QA in order for COA to be pulled and submitted accurately and efficiently.
• Ensure that products are manufactured to appropriate cGMP standards.
• Review MBR checklist and nonroutine holds on product (PPC’s, ECO’s) to verify all release criteria are met.
• Review media protocols to ensure all validation criteria are met.
• Review autoclave charts for verification of critical parameters and correct load configurations.
• Verify entries in inventory/release systems in relation to expiration dating and completed quantities.
• Verify test results in Laboratory Information Management System (LIMS).
• Approve release of intermediate product for further processing either in house or at 3rd party facilities.
• Coordinate the release of MBR’s (Master Batch Records) to ensure that all applicable standards and product specifications are met.
• Coordinate and process Certificate of Analysis, Certificate of Packaging, and Certificate of Conformance for specific country.
• Verify and close out aggregated serialized lots in appropriate systems Additionally.
• Contributes to group operational effectiveness by performing and reviewing SOP/document changes, supporting QA Operations projects, and supporting the implementation of corrective and preventative actions.
• Participating in deviation investigations and nonconformance review and approval.
• Coordinates with and works alongside QA operations technicians, production supervisors, procurement, and planning departments ensure timely release of product, control of nonconforming products, release of batches meeting all manufacturing and regulatory requirements, and resolve quality issues in order to release products.
• Work cohesively with team and demonstrate overtime flexibility for production needs.
• Act as a role model for company Values and Behaviors Interfaces – Coordinate with and support other departments to ensure smooth execution of work.

Minimum Requirements:

• Bachelor’s Degree or Equivalent years of directly related experience (or high school 8 yrs; Assoc. 4 yrs)
• The ability to fluently read, write, understand and communicate in English
• Work hours: Monday through Friday: 7:30am – 4:00pm
• Travel Requirements: 0 to 10%
• Relocation assistance: No
• Sponsorship available: No