Associate I, Quality Operations

Posted 16 Days Ago
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Sinking Spring, PA, USA
In-Office
Entry level
Healthtech • Biotech • Pharmaceutical
The Role
Supports quality operations for medical device or pharmaceutical manufacturing, including product and process validations, quality investigations, CAPA, supplier quality issues, product holds, quarantine, and quality data analysis. The role maintains documentation, develops validation protocols, coordinates manufacturing and testing activities, and supports continuous improvement and production-floor quality oversight in a regulated environment.
Summary Generated by Built In

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 Associate I, Quality Operations is primarily responsible for applying specialized knowledge to support project goals by monitoring product quality, resolving non-conformances, and maintaining documentation. You will use advanced quality management practices and conduct independent research.

In this role, a typical day will include:

  • Interact effectively with other facilities to support product tech transfer.
  • Support product validations through data collection.
  • Support/ execute validations, product, equipment, and manufacturing processes.
  • Ensure adequate product and process controls are in place for identified critical or major quality attributes/process parameters within assigned production areas.
  • Investigate and/or provide input on non-conformance events (NC), Corrective Actions, and Preventive Actions (CAPA) while providing guidance and approval.
  • Ensure supplier-related quality issues (i.e. customer complaints, non-conformances) with assigned commodities are corrected to prevent recurrence. Partner with the supplier on the use of root cause analysis tools paired with a formal corrective action process.
  • Ensures immediate action, including for cause visits, is taken with suppliers on issues deemed critical.
  • Track and trend NC and CAPA data with guidance using various statistical and non-statistical problem-solving tools as part of the analysis.
  • Lead product holds and quarantine when necessary.
  • Assist Manufacturing, Engineering, and other Quality functions to create a presence on the production floor to support the production process.
  • Support and promote improvement activities for production areas.
  • Uses various statistical and non-statistical problem-solving tools to analyze data, issues, or improvement opportunities.
  • Administer validation protocols associated with product/process changes including writing the initial protocol for qualification, scheduling the logistics of the protocol run with manufacturing, product testing, and evaluation writing a final technical summary to include conclusions drawn from the test data and subsequent recommendations.

WHAT YOU'LL BRING TO ALCON:

  • 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: Exempt
  • Work Location: Onsite
  • Travel Requirements: 5-10%
  • Relocation assistance: None
  • Sponsorship available: No

PREFERRED QUALIFICATIONS, SKILLS, & EXPERIENCE

  • Bachelor’s degree in Engineering (e.g., Mechanical, Industrial, Biomedical, or related field) preferred, recent graduates are encouraged to apply
  • Experience with medical devices or pharmaceuticals
  • Knowledge of Excel, Power Point and Minitab
  • Strong analytical, communication, and problem‑solving skills
  • Ability to work collaboratively in a fast‑paced, regulated environment
  • Interest in quality systems, manufacturing processes, and continuous improvement

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!

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 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 [email protected] and let us know the nature of your request and your contact information.

Skills Required

  • Bachelor's degree or equivalent directly related experience; alternatively, high school diploma plus 8 years of experience or associate degree plus 4 years of experience
  • Fluent ability to read, write, understand, and communicate in English
  • Ability to work onsite
  • Bachelor's degree in Engineering, such as Mechanical, Industrial, Biomedical, or a related field
  • Experience with medical devices or pharmaceuticals
  • Knowledge of Excel, PowerPoint, and Minitab
  • Strong analytical, communication, and problem-solving skills
  • Ability to work collaboratively in a fast-paced, regulated environment
  • Interest in quality systems, manufacturing processes, and continuous improvement

Alcon Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Alcon and has not been reviewed or approved by Alcon.

  • Retirement Support — Retirement benefits are framed as unusually strong, pairing a 401(k) match with an additional employer-funded retirement plan contribution. Stock purchase access and performance bonuses are also positioned as meaningful components of total rewards.
  • Healthcare Strength — Health coverage is described as comprehensive across medical, dental, vision, life, disability, and mental health support. Distinctive vision-related perks, including free contact lenses in some cases, reinforce the perceived strength of the health-and-wellness offering.
  • Leave & Time Off Breadth — Time-off offerings are characterized as robust, including paid holidays, PTO/vacation, paid sick time, and parental leave. Flexible time off for certain exempt roles and reported year-end shutdown periods further strengthen perceived coverage.

Alcon Insights

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The Company
HQ: Geneva
20,962 Employees
Year Founded: 1945

What We Do

Alcon helps people see brilliantly. As the global leader in eye care with a heritage spanning more than seven decades, we offer the broadest portfolio of products to enhance sight and improve people’s lives. Our Surgical and Vision Care products touch the lives of more than 260 million people in over 140 countries each year living with conditions like cataracts, glaucoma, retinal diseases and refractive errors. Our more than 20,000 associates are enhancing the quality of life through innovative products, partnerships with eye care professionals and programs that advance access to quality eye care.

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