Document Control Specialist

CooperCompanies • Victor, NY

6d • $23 - $30 • Onsite

About The Position

At CooperVision, a division of CooperCompanies, the Document Control Specialist supports the Quality Management System by executing Quality Assurance reviews for change control elements across local and global departments. The role revises and creates Standard Operating Procedures, Work Instructions, and other controlled documents with process owners and subject matter experts, using the Agile electronic Quality Management System to process documents and obtain approvals. It also reviews Change Orders and supports training.

The position may help establish local and global review procedures for change packages, engineering changes, engineering studies, and validations. It may also assist with investigations of Quality Feedback, Non-Conformance Reports, and other quality data, and participate in packaging verifications and validations. The role is full-time and requires onsite work five days per week in Victor, New York. Occasional domestic and international travel of less than 5% is required. The position is not eligible for relocation assistance or employer-sponsored work authorization.

Requirements

• At least 3 years of Quality Assurance or Document Control experience, including experience with ECOs, DCOs, NCRs, QFBs, SOPs, and change control processes in a regulated environment.
• High school diploma.
• Working knowledge of Microsoft Office Suite.
• Skills in applying continuous improvement, change management, and employee-team concepts.
• Ability to work with a diverse workforce.
• Knowledge of Quality Assurance regulations and methodologies, including Good Documentation Practices.
• Ability to perform light to medium physical work and stand for long periods when required by the task.
• Must be authorized to work in the United States permanently and on an ongoing basis without current or future employer-sponsored work authorization.

Nice To Haves

• Medical Device industry experience; experience in another regulated industry is also considered.
• Associate degree or equivalent combination of education and experience.
• Experience with Agile.

Responsibilities

• Act as change analyst for Document Change Orders and Deviations for controlled documents within assigned departments.
• Manage Training positions and roles in Agile for assigned local and global departments.
• Provide QA oversight to Service Non-Conformances generated by Customer Service.
• May assist management with review and approval of corrective and preventative actions, Nonconformance Reports, and Quality Feedbacks.
• May assist with process audits to verify conformance with standard operating procedures, including revising or creating SOPs as directed.
• Regularly provide status and updates to QA Management.
• Generate or contribute to monthly reports for departments and quality leadership as requested.
• Communicate information effectively from other departments to the QA team.
• Apply knowledge of Good Manufacturing Practices regulations, industry standards, and ISO general guidelines.
• Enter and analyze data in computer-based collection systems, including Access, Excel, and Agile.
• Ensure necessary reports are completed in a timely manner.
• Perform archiving as needed for quality records and may assist with record retention and retrieval or administer record retention activities.
• Perform or facilitate annual Quality Systems Regulation retraining as required by the quality management system.
• Work extended hours, including mandatory overtime, as business needs dictate to complete department goals or tasks.
• Perform other department-related assignments as directed by Leadership.
• Support Global Packaging and Global Supply Chain from a QA review perspective for Packaging and New Product Launch Change Orders, and provide guidance on compliance with change control regulations and company policies and procedures.
• May participate in establishing procedures for local and global review of change packages, engineering changes, engineering studies, and validations.
• May assist with investigations of Quality Feedback, Non-Conformance Reports, or other quality data, and participate in packaging verifications and validations.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED