Quality Assurance Coordinator (C-12hr Nights)

CooperVision, a division of CooperCompanies (NASDAQ:COO), 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. For more information, visit www.coopervision.com

Job Summary

With general guidance, coordinates the day-to-day activities of the Quality Assurance department, including: audits of 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. Trains or assists in training of new employees, while auditing trainees and engaging in dialogue with leadership in regards to progress. Works under minimal supervision.

Essential Functions & Accountabilities 

• Coordinates the daily activities within the Quality Assurance (QA) department with respect to prioritizing and organizing the daily work flow for the auditors. 
• Monitors and enforces compliance to Quality System Regulations (QSR). 
• Reports [to management] deviations from established procedures or product standards. 
• Serves as a resource to the QA Auditors when interpreting quality standards. 
• Trouble shoots and problem solves as needed. 
• Conducts document review of specifications to ensure procedures and product quality have been maintained. 
• Assists in process development, performing approved protocols, validations and qualifications through direction from leadership. 
• Updates SOP’s (standard operating procedures) and creates deviations. 
• Creates NCR’s (non-conformance reports); audits re-worked non-conformances. 
• Capable of performing verification audits to packaging lines and reporting the information accurately on required forms per SOP (standard operating procedure) guidelines includes responsibility for product release 
• Assists in internal audits including audits of: department’s procedures, processes and training records, to support approved protocols, validations and qualifications. 
• Assists leadership in establishment of product defect criteria.
• Trains or assists in training of new employees; performs audits on trainees to provide feedback to leadership on training progress. 
• Fills in, as needed, on day-to-day audit activities. 
• Continuously challenges the process as part of CooperVision’s Continuous Improvement culture.
• Serve as support to supervisor/management as necessary regarding performance and processes throughout the department while present, and a backup in the absence of supervisor/management. 
• 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.

This position is responsible for ensuring product is handled within the department per documented processes and that business and customer needs are met.

Qualifications

Knowledge, Skills and Abilities:

• Adheres to Standard Operating Procedures and Regulatory requirements. 
• Exhibits good communication skills – verbal, written, and comprehension of the English language. 
• Encourages and perpetuates open communication, as well as a team atmosphere, throughout the department. 
• Ability to work independently as well as in a team environment, while exhibiting effective leadership skills. 
• Must possess high level of attention to detail and accuracy. 
• Basic coursework in mathematics. 
• PC literate, including Microsoft Office Suite. 
• Knowledge of SPC (statistical process control). 
• Ability to utilize Agile (product lifestyle management tool) and ERP (enterprise resource planning tool). 
• Ability to operate pallet jack

Work Environment:

Normal Warehouse Cond