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CooperCompanies · 17 hours ago

Quality Assurance Auditor (12hr Nights)

180 Thruway Park Drive, West Henrietta, NY, 14586, US

Full-time

Onsite

Entry Level

$18.12/hr - $20.61/hr

1+ years exp

CooperVision, a division of CooperCompanies, is one of the world’s leading manufacturers of soft contact lenses. The role involves auditing packaging and distribution materials within an FDA regulated environment to ensure compliance with quality standards and reporting any nonconformance to established procedures.

Medical Device

Responsibilities

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

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

Qualification

Quality AssuranceFDA RegulationsMicrosoft Office SuiteAttention to DetailMathematicsPallet Jack OperationCommunication SkillsTeamwork

Required

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

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

High school diploma or GED required

Preferred

Experience in an FDA regulated setting a plus

Company

CooperCompanies

CooperCompanies (Nasdaq: COO) is a leading global medical device company focused on helping people experience life’s beautiful moments through its two business units, CooperVision and CooperSurgical.

Founded in 1958

San Ramon, California, US

10001+ employees