CooperVision a division of CooperCompanies (NASDAQ:COO) is one of the worlds 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. For more information visit .
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 CooperVisions rigorous quality standards. Immediately reports any and all nonconformance to established SOPs (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
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 CooperVisions 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. CooperVisions 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
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 between $18.12 and $20.61 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.
Required Experience:
IC
Live Brightly. Our daily and monthly soft contact lenses are designed with your health and comfort in mind. For every eye, every person, and every day.