Quality Management Systems Specialist

About the role

At CooperVision, a business unit of CooperCompanies (Nasdaq: COO), we’re driven by a unified purpose of helping people experience life’s beautiful moments. We are connected through our shared values - dedicated, innovative, friendly, partners, and do the right thing. As a leading global manufacturer of contact lenses, we are committed to helping improve the way people see each day. Through our diverse lens portfolio, we tackle the toughest vision challenges – including astigmatism, presbyopia, and childhood myopia. We offer the most complete collection of spherical, toric, and multifocal products available, enabling us to fit 99% of all contact wearers. Learn more at www.coopervision.com. This role is not eligible for employer-sponsored work authorization now or in the future. Applicants must be authorized to work in the United States on a permanent and ongoing basis without the need for future sponsorship (e.g., H1B, STEM OPT extensions, TN). This position is based in Victor, NY.

Responsibilities

• Responsible for conducting required Quality Assurance activities with local (Rochester) and global departments.
• Act as the lead Quality Analyst for quality records, problem reports, change orders and other quality processes.
• Support Document Control Specialists in the maintenance of Packaging and Labeling QMS data and ensuring CooperVision compliance to change control requirements for global processes.
• Oversight of cross-functional teams that provide input to the related processes.
• Work with key business stakeholders through change order and problem report processes.
• Act 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.
• Acts as the Quality Assurance representative and participates with cross functional teams on significant Packaging and Labeling projects (e.g., mass change for regulation update).
• Acts as the QA approver and change analyst for a variety of change orders (ECO, DCO, NPLCO, DRCO, and PCO).
• 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 associated Global Processes.
• Acts as final QA review prior to execution of changes where required.
• 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 required for the site and globally.
• Regularly provides status and updates to QA Management regarding state of 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.
• Conducts internal audits in any of the Rochester facility as required.
• Data entry and analysis into computer-based collection systems as required (Access, Excel & eQMS).
• 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.
• Per