QA Analyst II, Product Release

At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you'll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers.

We foster an inclusive culture and are looking for diverse, talented people to join Alcon. As a QA Analyst II, Product Release supporting our QC, Analysis and Test Service Team, you will be trusted to lead all aspects of the batch release process, ensuring that it is managed in compliance with corporate, regulatory, and industry standards, and maintaining product holds for potentially nonconforming product at Fort Worth, Texas in the US.

• Ensure release due report is accurate and updated.
• Monitor ECOs, NCIs and PPCs to ensure all PROs 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 so that COA is pulled and submitted accurately and efficiently.
• Ensure that products are manufactured to appropriate cGMP standards.
• Review M  checklist and non‑routine holds on product (PPCs, ECOs) 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 MBRs (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 countries.
• Verify and close out aggregated serialized lots in appropriate systems.
• Contribute to group operational effectiveness by performing and reviewing SOP/document changes, supporting QA operations projects, and supporting the implementation of corrective and preventative actions.
• Participate in deviation investigations and nonconformance review and approval.
• Coordinate with and work alongside QA operations technicians, production supervisors, procurement, and planning departments to 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 the team and demonstrate overtime flexibility for production needs.
• Act as a role model for company values and behaviors. Interface – coordinate with and support other departments to ensure smooth execution of work.

• Bachelor's Degree or Equivalent years of directly related experience (or high school +8 years; Associate +4 years)
• 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