Sr. QA Analyst I

Job Description:Alcon is the world's leading eye care company with sales of $5.6 billion. The company's nearly 13,000 employees worldwide, work in 75 facilities around the world to research, develop, manufacture and sell our products in more than 180 countries. Alcon is the largest specialty eye care company in the world and leads the growing $14.5 billion market for eye care products. For nearly 60 years, Alcon has delivered strong and stable growth, and it is positioned to build on this record in the years to come. For ten consecutive years, Fortune magazine has selected Alcon as "One of the 100 Best Companies to Work For". Alcon's U.S. General Office is based at its 300-acre campus located in Fort Worth, Texas.General Description: The incumbent will be responsible for performing, assessing and overseeing computer systems, automation and information systems validation projects with deliverables that include IOQs, PQs, functional requirements, requalification, change control, Part 11 assessments, risk assessments, investigations, SOPs supplier/software audits, and validation/project plans. Incumbent responsible for ensuring compliance to applicable federal, regulatory, industry, corporate, and plant software quality practices/standards; and coordinating with validation technicians, consultants, and applicable personnel during validation/project activities. Minimum Qualifications: Bachelor's degree in engineering sciences or information systems with five years of combined experience in software/computer systems/engineering quality testing and validation or equivalent in a pharmaceutical, manufacturing or regulated industry and project management two of which must be in pharmaceutical or manufacturing. Required skills include an in depth understanding of validation life cycle, software quality engineering, change control, FDA computer systems guidances/expectations and Part 11 requirements; hands-on experience on software testing, installation/operational qualification, performance qualification, requalification, and troubleshooting.Preferred Qualifications: Advanced degree in related discipline with three years experience in cGMP software and computer systems validation.Our generous benefits package includes the Alcon 401(k) Plan which matches employee contributions up to 5% of eligible pay at the rate of $1.00 for each dollar contributed, and the Alcon Retirement Plan (ARP), a qualified plan in which Alcon contributes 7% of eligible pay to the accounts of all eligible employees. By combining the Company's contributions to the 401(k) and ARP, employees can receive up to 12% of eligible pay from Alcon towards retirement. Alcon also offers medical, dental, vision, life and disability coverage, an on-site fitness center and much more. Consider having all this in a fast paced environment within a stable world-class organization.Alcon is an Equal Opportunity Employer committed to quality through diversity. M/F/D/V. Pre-employment drug testing.Click here to submit your resume via the Alcon Careers portal.Expected Travel Time: None