What are the responsibilities and job description for the QA Analyst II, Product Release position at Alcon?
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 the batch release process is managed in compliance with corporate, regulatory, and industry standards, and maintains product holds for potentially noncomforming product at Fort Worth, Texas in US.
Alcon is an Equal Opportunity Employer and participates in E-Verify. Alcon takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to alcon.recruitment@alcon.com and let us know the nature of your request and your contact information. Equal Employment Opportunity Posters: If you’d like to view a copy of the Alcon’s affirmative action plan or policy statement, please email alcon.er@alcon.com.
EEO Statement: Alcon is an Equal Opportunity Employer and takes pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or any other legally protected status.
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 the batch release process is managed in compliance with corporate, regulatory, and industry standards, and maintains product holds for potentially noncomforming product at Fort Worth, Texas in US.
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
Alcon is an Equal Opportunity Employer and participates in E-Verify. Alcon takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to alcon.recruitment@alcon.com and let us know the nature of your request and your contact information. Equal Employment Opportunity Posters: If you’d like to view a copy of the Alcon’s affirmative action plan or policy statement, please email alcon.er@alcon.com.
EEO Statement: Alcon is an Equal Opportunity Employer and takes pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or any other legally protected status.