Sr. Associate, ESO Quality Assurance Compliance

Alcon MX; Fort Worth (TX); On-site; USD 85,000 - 130,000; Full time

Benefits offered by this job

Health benefits

Life insurance

Retirement plan

Flexible time off

Job summary

Alcon is seeking a Sr. Associate, Quality Assurance Compliance (Professional Path) for the Fort Worth ASPEX Manufacturing Facility.

You will independently coordinate site gap assessments and apply advanced knowledge to support regulatory compliance of Alcon products produced by contract manufacturers. Responsibilities include managing QMS processes to ensure cGMP and ISO compliance, implementing the Quality Strategy, and supporting training and documentation in a regulated environment.

Qualifications

• Bachelor’s Degree or Equivalent years of directly related experience (or high school +10 yrs; Assoc.+6 yrs; M.S.+0 yrs)
• The ability to fluently read, write, understand, and communicate in English.
• 2 Years of Relevant Experience
• Work Location: Onsite
• Travel Requirements: None
• Relocation assistance: No
• Sponsorship available: No

Responsibilities

• Provide tactical site support to ensure compliance with site, Alcon, and international regulations.
• Coordinate site gap assessments and apply advanced knowledge to achieve objectives.
• Support Quality Management System harmonization and standardization.
• Manage Quality Systems Management processes to ensure cGMP and ISO compliance.
• Assist with Quality Strategy implementation and governance processes.

Skills

English fluency

Experience with audits

2 years of relevant experience

Education

Bachelor’s degree or equivalent

Job description

At Alcon, we're passionate about enhancing sight and helping people see brilliantly. With more than 25,000 associates, we innovate fearlessly, champion progress, and act swiftly to impact global eye health. We foster an inclusive culture, recognizing your contributions and offering opportunities to grow your career like never before. Together, we make a difference in the lives of our patients and customers. Are you ready to join us? This role is part of Alcon's Quality & Regulatory Affairs function, a team that ensures our products are in compliance with global, local, and internal regulations and meet the strictest standards of quality as we help people see brilliantly. The Sr. Associate, Quality Assurance Compliance (Professional Path) is primarily responsible for providing tactical site support to ensure compliance with site, Alcon, and international regulations at the Fort Worth ASPEX Manufacturing Facility. You will independently coordinate site gap assessments and apply advanced knowledge and skills to achieve objectives through self-directed work. This role is to support the external supply organization (ESO) for Alcon products produced by contract manufacturers. In this role, a typical day will include: Perform specialized tasks and conduct independent research to support the harmonization and standardization of the Quality Management System at Alcon, ensuring compliance with regulatory requirements. Manage Quality Systems Management processes to ensure compliance with current Good Manufacturing Practices (cGMP), Health Authority, and Alcon Quality Manual requirements, as well as International Organization for Standardization (ISO) standards. Facilitate the implementation of the Quality Strategy and support governance processes, identifying opportunities for improved process efficiencies and implementing changes. Manage Quality Information Systems and Training programs to support a robust and sustainable quality management system. Make significant decisions within the scope of assigned tasks, requiring advanced knowledge, analytical skills, and self-direction. Adhere to Good Practice (GxP) regulations by strictly following Standard Operating Procedures (SOPs), maintaining accurate and complete documentation, ensuring rigorous quality control, and completing all required training. Meet individual job requirements and contribute to the overall compliance of the organization, committing to continuous improvement and compliance with regulatory requirements. This role is part of Alcon's Quality Compliance Systems team for ASPEX which will primarily support CPDS and Product Change Control programs. This is not limited to these systems, however, will support all quality systems for the ASPEX manufacturing site.

WHAT YOU'LL BRING TO ALCON:

• Bachelor’s Degree or Equivalent years of directly related experience (or high school +10 yrs; Assoc.+6 yrs; M.S.+0 yrs)
• The ability to fluently read, write, understand, and communicate in English.
• 2 Years of Relevant Experience
• Work Location: Onsite
• Travel Requirements: None
• Relocation assistance: No
• Sponsorship available: No

PREFERRED EXPERIENCE:

• Demonstrated experience conducting and/or supporting audit activities.
• Experience with nonconformance investigations, CAPAs, and change requests.
• Strong technical writing and documentation skills.
• Proven ability to work effectively in cross-functional teams within a regulated environment

HOW YOU CAN THRIVE AT ALCON:

Join Alcon’s mission to provide outstanding, innovative products and solutions to improve sight, improve lives, and grow your career! Collaborate with teammates to share standard processes and findings as work evolves! See your career like never before with focused growth and development opportunities! Alcon provides a robust benefits package including health, life, retirement, flexible time off for exempt associates, PTO for hourly associates, and much more!

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.