Principal Analyst, ESO Supply Quality

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 PRINCIPAL ANALYST, ESO SUPPLY QUALITY, supporting our QUALITY ASSURANCE TEAM, you will be trusted with managing quality aspects at external suppliers for Biopharmaceuticals / Pharmaceutical / Devices and to ensure that the operational business is in compliance with cGMP, the Quality Assurance Agreement, regulatory requirements and the Quality Manual and is conducted according to the relevant SOPs.at the ASPEX FORT WORTH MANUFACTURING FACILITY in FORT WORTH, TEXAS, US.

In this role, a typical day will include:

• Act as Single Point of Contact / Major Accountabilities for all quality related activities at the External Supplier to ensure that all aspects of the handling, manufacturing and distribution of pharmaceutical and medical device products are in compliance with the Quality Manual, the effective Quality Agreement meets relevant cGMP regulatory requirements and are conducted according to local SOPs.

• Lead External Suppliers Qualification process.

• Responsible for driving / initiating External Supplier Quality Risk assessments to be carried out for all External Suppliers.

• Provide the quality presence and input to Technical meetings with the External suppliers and establish good working relationships with clear communication and defined actions and goals.

• Ensure that a valid QA agreement defined in line with the requirements of the Global template is in place which clearly defines cGMP roles and responsibilities between Alcon and the External Supplier, as well as Product details and requirements.

• Manage the quality aspects of the relationship in accordance with the effective Quality Agreement.

• Responsible for coordinating and ensuring that Quality auditing of External suppliers is carried out according to the Alcon Quality Manual maintain an annual auditing program, participate in and/or lead audits, manage action plans and follow up on agreed upon CAPAs.

• Manage critical quality issues (deviations, complaints, recalls, counterfeits and product tampering, stability failures, etc) according to the Quality Agreement and the Alcon Quality Manual.

• Ensure investigations are correctly executed.

• Act as control checkpoint for final and/or in-process release authorization.

WHAT YOU'LL BRING TO ALCON:

• Bachelor's Degree or Equivalent years of directly related experience (or high school +13 yrs; Assoc.+ 9 yrs; M.S.+ 2 yrs; PhD+0 yrs)

• The ability to fluently read, write, understand, and communicate in English

• 5 Years of Relevant Experience

• Work hours: Day Shift - Monday through Friday

• Travel Requirements: 0 to 25%

• Relocation assistance: No

• Sponsorship available: No

HOW YOU CAN THRIVE AT ALCON:

• Collaborate with teammates to share standard processes and learnings as work evolve

• See your career like never before with focused growth and development opportunities

• Join Alcon's mission to provide outstanding, innovative products and solutions to improve sight, improve lives, and grow your career!

• Alcon provides robust benefits package including health, life, retirement, flexible time off for exempt associates; PTO for hourly associates, and much more!

ATTENTION: Current Alcon Employee/Contingent Worker

If you are currently an active employee/contingent worker at Alcon, please click the appropriate link below to apply on the Internal Career site.

Find Jobs for Employees

Find Jobs for Contingent Worker

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.