Sr QA Analyst-Complaints FWN

4 weeks ago

Fort Worth, Texas, United States Alcon Full time

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 SR QA ANALYST-COMPLAINTS you will be responsible for the management of customer complaints including documentation, logging on through iTrack, investigation and root cause analysis, associated corrective actions and preventative actions (CAPA) activities, tracking, trending and reporting. Implementation of local quality systems that comply with standards and regulatory requirements. at our FORT WORTH NORTHMANUFACTURING FACILITY at FORT WORTH, TEXAS, (US).

In this role, a typical day will include:

  • Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established standards and agency guidelines.
  • A thorough understanding manufacturing facility, process, procedures, and equipment is required. May receive technical guidance on complex problems, but independently determines and develops approaches and solutions.
  • Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and agency guidelines to assure compliance.
  • Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet guidelines.
  • Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.
  • Co-ordinates legal requests in support of government investigations or litigations. Ensures the quality assurance programs and policies are maintained and modified regularly. Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally.
  • Ensure operational, review timelines, projects, and assigned tasks are completed on time and per procedural guidelines
  • Independently carry out work as required to meet defined deadlines and operational KPI goals.
  • Organize work and effectively execute time management.
  • Accurately scope length and difficulty of task and projects.
  • Perform activities that ensure required quality and safety standards are being met for our products.
  • Assure GMP requirements/compliance are adhered.
  • Escalate quality issues.
  • Technical involvement of projects.
  • Support regulatory actions as needed Interfaces - Coordinate/support other departments to ensure smooth execution of work.
  • Work with cross functional teams to analyze data and create solutions.
  • Communicate effectively with production, laboratories, maintenance, warehouse, and other functions as necessary
  • Communicate trends and potential issues to upper management and internal departments.
  • Effective presentation skills in one on one, groups, peers, and upper management settings.

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 hours: Monday through Friday - from 8:00am - 5:00pm
  • Travel Requirements: 0 to 10%
  • 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.

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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 and let us know the nature of your request and your contact information.

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