What are the responsibilities and job description for the QA Analyst I position at Alcon?
Job Title: QA Analyst I
Location: Fort Worth, TX (North Mfg)
At Alcon, we help our customers see brilliantly. As the world’s leading contact lens and eye care manufacturer, Alcon is looking to hire a to hire a Quality Analyst I to join our Fort Worth North Manufacturing Team in Fort Worth, TX. Working for a large global organization, you will have an opportunity to grow and build a great, dynamic, and rewarding career.
- 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, release systems, Laboratory management system, Change Control, Update Databases, Release of intermediates and finished goods.
- Approve shipments under quarantine, Ownership of Documents related to job function, Support 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 ATP's related to testing programs, laboratory operations and/or equipment operation.
- Market/Production Support, Resolve Holds, Support MBR Review, Issue MBRs and Support Investigations.
- Ensure precise planning related to production schedules and compliance 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 and procedures.
- 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 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.
- Ensure work areas are clean and safe, and audit ready at all times.
- Continuously monitor work areas; identify, resolve, and report safety hazards.
- Ensure materials are handled and disposed of properly, per HSE standards.
Key Requirements/Minimum Qualifications:
- Bachelor’s Degree or equivalent years of directly related experience (or high school 8 yrs; Assoc. 4 yrs)
- The ability to fluently read, write, understand and communicate in English.
- Work hours: 2nd shift (2pm-11pm)
- Travel Requirements: 0%
- Relocation assistance: No
- Sponsorship assistance: No
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.
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