Quality Assurance Auditor (12hr Nights)
CooperSurgical
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 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 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 including incoming raw materials (packaging consumable materials)
- DHR (device history record) review, product label and package review, including responsibility for product release
- Process audits to verify conformance within established quality standards, including advising and working with leadership on possible improvements
- Reports deviations from established procedures or product standards to management
- 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
- Works extended hours to complete daily department goals or tasks to include mandatory overtime as business needs dictate
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
- 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
- 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 verbal and written communication skills and English comprehension
- Ability to work independently and 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 (preferred)
- Authorized to work in the United States without sponsorship
- Full-time onsite work in West Henrietta, NY
Company overview
CooperSurgical is a leading global medical device company specializing in women's health and fertility solutions. As a subsidiary of The Cooper Companies, the organization focuses on developing and manufacturing innovative products for reproductive medicine, fertility treatment, and women's healthcare. The company's comprehensive portfolio includes products for assisted reproductive technology (ART), embryo transfer systems, cryopreservation solutions, and diagnostic instruments used in fertility clinics worldwide. CooperSurgical plays a critical role in advancing reproductive medicine through its commitment to research, development, and clinical education. The company collaborates closely with fertility specialists and healthcare providers to address the complex needs of patients undergoing fertility treatments. With a strong presence in both domestic and international markets, CooperSurgical continues to expand its offerings through strategic acquisitions and organic growth, maintaining its position as a trusted partner in the fertility and women's health sectors.