Document Control Specialist

Job Summary

Responsible for executing required QA review activities for change control elements associated with local and global departments in support of the Quality Management System. Will revise and 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 Agile electronic Quality Management System (eQMS) to process these documents and obtain approvals as well as review Change Orders and support training.

Responsibilities

• Act as change analyst for Document Change Orders (DCO’s) and Deviations for all controlled documents within assigned departments.
• Manages Training positions and roles in Agile for assigned local and Global departments.
• Provides QA oversight to Service Non-Conformances (SNC’s) generated by Customer Service.
• May assist management with review and approval of corrective and preventative action (CAPA), Nonconformance Reports (NCR), and Quality Feedbacks (QFB).
• May assist with process audits to verify conformance with standard operating procedures.
• This will include revising and or creating SOP as directed.
• Regularly provides status and updates to QA Management.
• Generate or contribute to monthly reports provided to various departments and quality leadership as requested.
• Communicates information effectively from other departments to the QA team.
• Applies knowledge of Good Manufacturing Practices (GMP) regulations and industry standards as well as ISO general guidelines.
• Data entry and analysis into computer-based collection systems (Access, Excel & Agile).
• Ensures that all necessary reports are completed in a timely manner.
• Performs archiving as necessary as it applies to quality records.
• May assist in all aspects of record retention and retrieval.
• Performs or facilitates annual Quality Systems Regulation (QSR) retraining as required by the quality management system.
• Support Global Packaging and Global Supply Chain from QA review perspective for Packaging and New Product Launch Change Orders (PCO and NPLCO) and provide guidance on requirements to ensure compliance with change control regulations and CooperVision policies and procedures.

Qualifications

• Working of knowledge of Microsoft Office Suite.
• Experience with Agile preferred.
• Should possess 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.
• Work experience in Medical Device industry preferred; other regulated industry experience considered.
• Education: HS diploma required; Associates degree or equivalent combination of education and experience preferred.