Quality Assurance Auditor

At CooperVision, a business unit of CooperCompanies (Nasdaq: COO), we’re driven by a unified purpose of helping people experience life’s beautiful moments. We are connected through our shared values - dedicated, innovative, friendly, partners, and do the right thing. As a leading global manufacturer of contact lenses, we are committed to helping improve the way people see each day. Through our diverse lens portfolio, we tackle the toughest vision challenges – including astigmatism, presbyopia, and childhood myopia. We offer the most complete collection of spherical, toric, and multifocal products available, enabling us to fit 99% of all contact wearers. Learn more at www.coopervision.com

• This role is not eligible for employer-sponsored work authorization now or in the future. Applicants must be authorized to work in the United States on a permanent and ongoing basis without the need for future sponsorship (i.e., H1B, STEM OPT extensions, TN, etc.)
• This position requires full-time onsite work (5 days per week) in West Henrietta, NY and is not eligible for relocation assistance.

Job Summary

Audits Packaging and Distribution materials and goods, as well as activities, within an FDA regulated environment to ensure conformance to external regulations, as well as CooperVision’s rigorous quality standards. Immediately reports any and all nonconformance to established SOP’s (standard operating procedure); Utilizes process control tools [sampling/testing guidelines] to evaluate conformance to these standards, while actively engaging Packaging and Distribution personnel. Employee works under minimal supervision

Knowledge, Skills and Abilities: 

Adheres to Standard Operating Procedures and Regulatory requirements.

 • Exhibits good communication skills – verbal, written, and comprehension of the English language. 

• Ability to work independently as well as in a team environment.

 • Must possess high level of attention to detail and accuracy.

 • Basic coursework in mathematics. 

• PC literate, including Microsoft Office Suite.

 • Maintains an ongoing understanding of current QA (quality assurance) procedures.

 • Ability to operate pallet jack. 

Work Environment:

Normal Warehouse Conditions:

Noisy conditions - 50-75%

 Hot or humid conditions - >75% 

Exposure to extreme seasonal temperatures - >75% 

Work near moving mechanical parts - >75% 

Physical Demands: 

Standing - 25-50% Sitting - 50-75% 

Walking - 25-50% 

Bending - <25% 

Stooping - <25% 

Kneeling - <25% 

Crouching - <25% 

Twisting - <25% 

Pushing - <25% Hand/eye coordination - >75% 

Finger/wrist dexterity - >75% 

Grasping/Pinching - 75% 

Lifting (up to 25 lbs.) - <25%

Experience:

Minimum of 1 year experience in a Packaging or Distribution [warehouse] environment required. 

• Minimum of 1 year experience in a Quality Control or Quality Assurance environment required. • Experience in an FDA regulated setting a plus.

Education:

High school diploma or GED required.

For U.S. locations that require disclosure of compensation, the starting base pay for this role is $20.00 per hour and may include cost of living adjustments.  The actual base pay includes many factors and is subject to change and modification in the future. This position may also be eligible for other types of compensation and benefits.

We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace.

1.Performs audits as directed by management that include, but are not limited to:

 a. Incoming raw materials (packaging consumable materials) 

b. DHR (device history record) review, product label and package review, includes responsibility for product release 

c. Process audits to verify conformance within established quality standards, including advising, and working with, leadership on possible improvements.

 2. Reports [to management] deviations from established procedures or product standards. 

3. Participates in problem solving with management, and through direct interaction with Packaging and Distribution staff. 

4. Assists in process development, performing approved protocols, validations and qualifications through direction from leadership.

 5. Continuously challenges the process as part of CooperVision’s Continuous Improvement culture. 

6. Performs other duties as assigned. 

7. As business needs dictate, works extended hours to complete daily department goals or tasks to include mandatory overtime.