Associate I, Quality Operations

Alcon MX; Fort Worth (TX); On-site; USD 55,000 - 75,000; Full time

Job summary

Alcon is seeking a QA Analyst I to support the Fort Worth North Manufacturing team. You will perform in-process and final product quality analyses, ensuring compliance with cGMP standards and regulatory requirements.

Responsibilities include reviewing deviations, data interpretation, and supporting audits while maintaining up-to-date QA documentation and procedures for timely product release.

Responsibilities

• Ensure products comply with applicable standards.
• Review deviations across processes in operations (including compounding, filling, packaging, and product release).
• Assist in audits and aseptic audits; support investigations and logbook processing.
• Collect, calculate, and interpret test results; ensure QA documents and SOPs are current.
• Collaborate with Operations to release quality product and meet schedules.

Skills

QA Analyst

Tools

Maximo

Release systems

Laboratory management system

MES

Trackwise

Team Center

Change Control

Update Databases

Release of intermediates and finished goods

Job description

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 I supporting Fort Worth North Manufacturing team, you will be responsible for in-process and final product quality analyses/inspection in compliance with standards and regulatory requirements at Fort Worth North Manufacturing in Fort Worth, Texas.

In this role, a typical day will include:

• Ensure products comply with applicable standards.
• Ensure that products are manufactured to appropriate cGMP standards by reviewing all deviations related to all processes within operations, including compounding, filling, packaging and product release.
• Knowledge of Systems required to perform job function such as: Inventory systems, Maximo, release systems, Laboratory management system, MES, Trackwise, Team Center, Change Control, Update Databases, Release of intermediates and finished goods.
• Approve shipments under quarantine,
• Ownership of Documents related to job function,
• Support Audits and Aseptic Audits,
• Logbook processing.
• Perform routine analysis of raw materials, finished goods, products, packaging components, complaints, investigations per schedule and per standards/SOPs.
• Collect, calculate, and interpret test results.
• Take ownership and execute revisions for SOPs and related to testing programs, laboratory operations and/or equipment operation.
• Market/Production Support, Resolve Holds, Support MBR Review in MES, Issue MBRs and Support Investigations.
• Ensure precise planning related to production schedules, compliance and validations activities.
• Plan and schedule work activities based on production schedules, product release needs, media program, shutdown activities and changing priorities.
• Responsible for contributing to meet group deadlines.
• Assure training and qualifications are current.
• Provide guidance to production and maintenance groups on intervention recovery methods in the aseptic areas.
• Author, review and approve QA documents, procedures and Preventive Maintenance.
• Assist in smoke studies, media program and other validation/compliance activities in the aseptic areas.
• Review and approve sterility break request forms.
• Collaborate with Operations team to manufacture product that is high in quality and meets all regulatory and company requirements.
• Ensure supplies and equipment are available to meet schedules.
• Plan and schedule work activities based on production schedules and input from external functional groups.
• Take ownership and contribute to solving problems.
• Drive continuous improvement projects to completion ahead of deadlines.
• Proactively share critical expertise and help individuals understand their role in the group.
• Build relationships within QA and with cross functional departments to help achieve business goals.
• Demonstrate overtime flexibility for production needs.
• Exhibit company values and behaviors.
• Coordinate with and support other departments to ensure smooth execution of work.
• Work cohesively with Production and other departments to resolve issues in order to release quality product.
• Ensure work areas comply with applicable standards (HSE, GMP, etc.).
• Promote/reinforce company and department HSE standards, through regular communication, training, and reminders.
• Consistently exhibit safe behaviors and wear proper PPE.

ALCON IS AN EQUAL OPPORTUNITY EMPLOYER AND PARTICIPATES IN E-VERIFY Alcon takes pride in maintaining an inclusive environment that values different perspectives and our policies are non-discriminatory in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, 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 [e-mail] and let us know the nature of your request and your contact information.

At Alcon, we are committed to helping people see better. We believe patients should have access to quality eye care regardless of their economic circumstances; however, barriers to good eye health exist for patients in both developed and emerging markets. Alcon develops and manufactures innovative devices to serve the full life cycle of eye care needs. Its surgical group is one of the largest makers of equipment used for cataract removal and laser vision correction. Its consumer products include the well-known Opti-Free line of contact lens solutions and related products. Alcon, which was founded in 1945, sells its products in 180 countries worldwide.