QA Change Control & Document Specialist

CooperVision; Town of Victor (NY); On-site; USD 31,000 - 42,000; Full time

Job summary

CooperVision, a leading global contact lens manufacturer, is seeking a QA Document Control Analyst in Victor, NY to manage change orders, SOPs, and controlled documents within the eQMS. You will collaborate with process owners and QA professionals to ensure compliance and accuracy.

The role requires 3 years of document control experience in regulated environments, a HS diploma, and strong proficiency in Microsoft Office and data tracking.

Qualifications

• 3 years of experience with document control (ECO, DCO, NCR, QFB, and SOP or equivalent).
• Medical Device industry experience preferred.
• HS diploma required; associates degree preferred.

Responsibilities

• Act as change analyst for Document Change Orders (DCOs) and Deviations for all controlled documents within assigned departments.
• Manages Training positions and roles in Agile for local and Global departments.
• Provides QA oversight to Service Non-Conformances (SNCs) generated by Customer Service.
• Assist with review/approval of CAPA, NCR, and QFB; participate in process audits.

Skills

Microsoft Office Suite

Agile knowledge

Continuous improvement

Education

HS diploma

Associates degree or equivalent preferred

Tools

Access

Excel

Job description

CooperVision, a leading global contact lens manufacturer, is seeking a QA Document Control Analyst in Victor, NY to manage change orders, SOPs, and controlled documents within the eQMS. You will collaborate with process owners and QA professionals to ensure compliance and accuracy.

The role requires 3 years of document control experience in regulated environments, a HS diploma, and strong proficiency in Microsoft Office and data tracking.