CooperVision · 2 days ago
Document Control Specialist
Victor, NY
Full-time
Onsite
Mid Level
$35/hr - $50/hr
3+ years expCooperVision is one of the world’s leading manufacturers of soft contact lenses, committed to solving vision challenges. The Document Control Specialist will execute QA review activities, revise and create Standard Operating Procedures, and support the Quality Management System.
Health CareManufacturingMedical Device
Hiring Manager
Arifa I Kazmi, PHR
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. May act as Administrator for record retention activities
Perform or facilitate annual Quality Systems Regulation (QSR) retraining as required by the quality management system
As business needs dictate, works extended hours to complete daily department goals or tasks, to include mandatory overtime
Performs other assignments related to the department as directed by Leadership
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
Administers lot blocking process
Qualification
Required
3 years of experience with document control (ECO, DCO, NCR, QFB, and SOP or equivalent) required
HS diploma required
Working of knowledge of Microsoft Office Suite
Knowledge of Quality Assurance regulations and methodologies, including Good Documentation Practices
Preferred
Experience with Agile preferred
Medical Device industry experience preferred; other regulated industry experience considered
Associates degree or equivalent combination of education and experience preferred
Company
CooperVision
CooperVision is one of the world’s leading manufacturers of soft contact lenses and related products and services. It is a sub-organization of The Cooper Companies.
5001-10000 employees
H1B Sponsorship
CooperVision has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (9)
2024 (12)
2023 (14)
2022 (7)
2021 (13)
2020 (11)
Funding
Current Stage
Late StageLeadership Team
Michael Good
Divisional Chief Financial Officer
Recent News
2026-01-06
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2025-09-28
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