QA System Specialist - CONTRACT

CooperVision • Victor, NY

295d • $26 - $35

About The Position

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: Responsible for conducting required Quality Assurance activities with local (Rochester) and global departments. Act as the lead for the maintenance of Packaging and Labeling QMS data and ensuring CooperVision compliance to change control requirements for global processes. Oversight over cross-functional teams which provide input to the related processes. Responsible for working with key business stakeholders through the Product Launch Process and Packaging Configuration approval. Acts as site lead for a variety of problem reports (CAPA/NCR/etc.), ensuring timely movement through the process while safeguarding compliance. Involvement with internal auditing for local CooperVision sites. Will revise and at times create Standard Operating Procedures (SOP's), Work Instructions (WI's) and other controlled documents in collaboration with process owners and subject matter experts. Will utilize the electronic Quality Management System (eQMS) to process these documents and obtain approvals as well as review Change Orders and support training. Participation with establishing procedures for Global review of change packages as well as engineering changes, engineering studies, and validations when necessary.

Requirements

• Excellent written, oral, and interpersonal communication skills
• Highly self-motivated, self-directed and attentive to detail
• Well organized and detail oriented, strong data entry and analysis
• Highly adaptable, flexible and willing to accept new ideas, processes and procedures
• Excellent analytical and problem-solving skills, with strong attention to detail. Ability to drive to root cause
• Ability to effectively prioritize and execute tasks, and meet project deadlines in a fast-paced environment
• Working knowledge of Microsoft Office Suite. Experience with Agile preferred
• Possesses skills to utilize the concept of continuous improvement, change management and employee teams. Ability to work with a diverse workforce
• Knowledge of Quality Assurance regulations and methodologies, including Good Documentation Practices. Ability to enforce standards (QSR, CVI, etc.) and standardize global processes

Nice To Haves

• Lead auditor experience preferred
• Medical Device industry experience preferred

Responsibilities

• Acts as the Quality Assurance representative and participates with cross functional teams on significant Packaging and Labeling projects (example. mass change for regulation update).
• Acts as the QA approver and change analyst for Packaging and New Product Launch Change Orders (PCO and NPLCO).
• Provides guidance and is the QA lead on process requirements to ensure compliance with change control regulations and CooperVision policies and procedures.
• SME for Quality Assurance in both Global Processes.
• Acts as final QA review prior to execution of new product launch. Responsible for ensuring all requirements are met prior to final release.
• Lead in continuous improvement efforts to streamline the QA review in above mentioned processes.
• Acts as change analyst for Document Change Orders (DCO's) and any required Deviations for functional departments residing under the CooperVision QMS at the site.
• Manages Training positions and roles in Agile for functional departments residing under the CooperVision QMS at the site.
• Reviews and participates in implementation of global document changes document required for the site.
• Regularly provides status and updates to QA Management regarding state of Packaging and Labeling QMS data and continuous improvement projects.
• Communicates information effectively to and from other departments with the QA team.
• Investigation, lead, coordinate, reviews and approvals of corrective and preventative action (CAPA) and nonconformance's (NCR).
• Assists with internal and process audits to verify conformance with standard operating procedures. This will include revising and or creating SOPs as needed. Conducts internal audits in any of the Rochester facility as required.
• Data entry and analysis into computer-based collection systems as required (Access, Excel & Agile).
• Performs archiving (as necessary) as it applies to quality records for the site. May assist in all aspects of record retention and retrieval. May act as Administrator for record retention activities.
• Provides eQMS and required QSR training for employees at the site. Applies knowledge of Good Manufacturing Practices (GMP) regulations and industry standards as well as ISO general guidelines.
• Performs other assignments related to the department as directed by Leadership.

Benefits

• Starting base pay for this role is between $26.00 and $35.00 per hour
• May include cost of living adjustments
• Eligible for other types of compensation and benefits

What This Job Offers

• Job Type: Full-time
• Industry: Merchant Wholesalers, Durable Goods
• Education Level: Bachelor's degree