Quality Management Systems Specialist

Essential Functions & Accountabilities

• 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 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 document 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.  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 & 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.
• Performs other assignments related to the department as directed by Leadership

• 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

Experience