Quality Assurance Auditor (12hr Nights)
CooperVision
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 SOPs; 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.
Job description
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 SOPs; 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.
Responsibilities
- Performs audits as directed by management that include, but are not limited to: Incoming raw materials (packaging consumable materials)
- DHR (device history record) review, product label and package review, includes responsibility for product release
- Process audits to verify conformance within established quality standards, including advising, and working with, leadership on possible improvements
- Reports [to management] deviations from established procedures or product standards
- Participates in problem solving with management, and through direct interaction with Packaging and Distribution staff
- Assists in process development, performing approved protocols, validations and qualifications through direction from leadership
- Continuously challenges the process as part of CooperVision's Continuous Improvement culture
- Performs other duties as assigned
- As business needs dictate, works extended hours to complete daily department goals or tasks to include mandatory overtime
Qualifications
- 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 procedures
- Ability to operate pallet jack
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.
Requirements
- Minimum of 1 year experience in a Packaging or Distribution warehouse environment
- Minimum of 1 year experience in a Quality Control or Quality Assurance environment
- High school diploma or GED
- Adheres to Standard Operating Procedures and Regulatory requirements
- Good communication skills – verbal, written, and comprehension of the English language
- Ability to work independently as well as in a team environment
- High level of attention to detail and accuracy
- Basic coursework in mathematics
- PC literate, including Microsoft Office Suite
- Ability to operate pallet jack
- Experience in an FDA regulated setting a plus
Company overview
CooperVision is a global leader in contact lens manufacturing and a business unit of The Cooper Companies, Inc. Founded in 1980 and headquartered in San Ramon, California, the company has established itself as one of the world's largest manufacturers of soft contact lenses. CooperVision operates through a comprehensive portfolio that includes daily disposable, two-week, and monthly soft contact lenses featuring advanced materials and optical technologies. The company specializes in addressing complex vision challenges such as astigmatism, presbyopia, childhood myopia, and irregular corneas through its extensive range of spherical, toric, and multifocal products. With manufacturing facilities across multiple countries including the United States, Puerto Rico, Costa Rica, Hungary, and England, CooperVision serves customers in over 100 countries worldwide. The company maintains a strong commitment to scientific innovation, operational excellence, and close collaboration with eye care professionals to develop solutions that meet diverse vision correction needs. CooperVision's product lines include popular brands like Biofinity, MyDay, clariti, and MiSight, with the latter being specifically designed for myopia control in children. As a subsidiary of the publicly traded CooperCompanies (NYSE: COO), CooperVision employs approximately 5,000-10,000 people globally and generates annual revenues estimated between $1-5 billion.