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 and we are looking for a QA Analyst in Puerto Rico. As QA Analyst, you will support quality compliance with local and Alcon Corporate requirements, support and maintain the processes and procedures needed for an effective Quality Management System, covering all necessary GxP, Quality regulations and standards. You will also provide support for all incoming products that are received, inspected, stored, handled, released, distributed, transported and destroyed according to labelled, regulatory and GxP requirements working out of the Cataño, PR facility.

In this role, a typical day will include:

• With supervision, support quality compliance with local and Alcon Corporate requirements.
• Support and maintain the processes and procedures needed for an effective Quality Management System, covering all necessary GxP, Quality regulations and standards, including but not limited to, return product inspections, self-inspections, supplier qualifications, DCT/NCI/CAPA process and SOP revision and compliance.
• Support for all incoming and returned products that are received, inspected, stored, handled, released, distributed, transported and destroyed according to labelled, regulatory and GxP requirements.
• Support the implementation of Alcon Quality System Procedures (QSPs, MSPs, FSPs) at local level and ensure local SOPs and/or work instructions are in place if needed, including revision and managing adequate and timely training assignments.
• Ensure document management system is followed by providing support during retention and document destruction.
• Support the continuous improvement by management of local deviations through the identification, investigation, root cause determination, documentation, follow up and closure of Corrective Actions. Support Escalations as required.
• Responsible of ensuring GxP suppliers are properly qualified by maintaining local documentation up to date including certifications, permits, QAA, contracts. Responsible for the suppliers monitoring completion per frequency established in local procedure and Alcon Quality requirements (e.g. warehouse, distribution)
• Support the audit self-inspection program and external audits of GxP suppliers by planning, conducting and generating reports when required.
• Support the preparation of external Quality System audits by Notified bodies and Health Authorities as needed. Provide support to additional regulatory tasks when needed.
• Generate and review adequate Change Controls.
• Support the management of complaints, recalls, counterfeits and product tampering according to the Alcon Corporate Quality Manual and escalations, if required.
• Support BCP activities (SOP revision and testing completion)
• Manage the destruction program, calibration program and preventive maintenance program of Alcon PR in alignment with Warehouse area
• Provide support to Validation and Revalidation activities
• Support QA/RA projects when needed

• With supervision, support quality compliance with local and Alcon Corporate requirements.
• Support and maintain the processes and procedures needed for an effective Quality Management System, covering all necessary GxP, Quality regulations and standards, including but not limited to, return product inspections, self-inspections, supplier qualifications, DCT/NCI/CAPA process and SOP revision and compliance.
• Support for all incoming and returned products that are received, inspected, stored, handled, released, distributed, transported and destroyed according to labelled, regulatory and GxP requirements.
• Support the implementation of Alcon Quality System Procedures (QSPs, MSPs, FSPs) at local level and ensure local SOPs and/or work instructions are in place if needed, including revision and managing adequate and timely training assignments.
• Ensure document management system is followed by providing support during retention and document destruction.
• Support the continuous improvement by management of local deviations through the identification, investigation, root cause determination, documentation, follow up and closure of Corrective Actions. Support Escalations as required.
• Responsible of ensuring GxP suppliers are properly qualified by maintaining local documentation up to date including certifications, permits, QAA, contracts. Responsible for the suppliers monitoring completion per frequency established in local procedure and Alcon Quality requirements (e.g. warehouse, distribution)
• Support the audit self-inspection program and external audits of GxP suppliers by planning, conducting and generating reports when required.
• Support the preparation of external Quality System audits by Notified bodies and Health Authorities as needed. Provide support to additional regulatory tasks when needed.
• Generate and review adequate Change Controls.
• Support the management of complaints, recalls, counterfeits and product tampering according to the Alcon Corporate Quality Manual and escalations, if required.
• Support BCP activities (SOP revision and testing completion)
• Manage the destruction program, calibration program and preventive maintenance program of Alcon PR in alignment with Warehouse area
• Provide support to Validation and Revalidation activities
• Support QA/RA projects when neede