Website Cooper Cos.
Cooper Cos.
Company : Cooper Cos.
Auditor
CooperVision, a division of CooperCompanies, is one of the world's leading manufacturers of soft contact lenses. The company produces a full array of daily disposable, two-week and monthly contact lenses, all featuring advanced materials and optics. CooperVision has a strong heritage of solving the toughest vision challenges such as astigmatism, presbyopia and childhood myopia; and offers the most complete collection of spherical, toric and multifocal products available. Through a combination of innovative products and focused practitioner support, the company brings a refreshing perspective to the marketplace, creating real advantages for customers and wearers.
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
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 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. CooperVision's management team is committed to the development of and implementation of the quality management system and maintaining its effectiveness by communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements
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 (quality assurance) procedures. Ability to operate pallet jack. Noisy conditions – 50-75% Hot or humid conditions – >75% Exposure to extreme seasonal temperatures – >75% Work near moving mechanical parts – >75% Standing – 25-50% Sitting – 50-75% Walking – 25-50% Bending – <25% Stooped – <25% Kneeling – <25% Crouching – <25% Twisting – <25% Hand/eye coordination – >75% Finger/wrist dexterity – >75% Grasping/Pinching – 75% Lifting (up to 25 lbs.) – <25% 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.