QA Change Control Specialist: Document & SOP Lead

CooperVision Limited; Town of Victor (NY); Presencial; USD 31 000 - 42 000; Tempo integral

Resumo da oferta

CooperVision, a division of CooperCompanies, is seeking a QA Change Analyst to support the Quality Management System. The role involves creating and revising SOPs and WI’s, processing documents through the eQMS, and reviewing change orders. Travel is occasional, with on-site work in Victor, NY.

The candidate will participate in change control, CAPA, NCR, and QFB processes, and ensure GMP/ISO compliance while collaborating with global process owners and subject matter experts.

Qualificações

• 3+ years of Quality Assurance or Document Control experience required, including ECOs, DCOs, NCRs, QFBs, SOPs, and change control processes.

Responsabilidades

• Act as change analyst for DCOs 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 generated by Customer Service.
• May assist management with review and approval of CAPA, NCR, and QFB.

Conhecimentos

Quality Assurance

Document Control

SOPs & GMP

eQMS

Data Analysis

Formação académica

Associates degree or equivalent combination of education and experience preferred

Ferramentas

Microsoft Office

Excel

Access

Agile

Descrição da oferta de emprego

CooperVision, a division of CooperCompanies, is seeking a QA Change Analyst to support the Quality Management System. The role involves creating and revising SOPs and WI’s, processing documents through the eQMS, and reviewing change orders. Travel is occasional, with on-site work in Victor, NY.

The candidate will participate in change control, CAPA, NCR, and QFB processes, and ensure GMP/ISO compliance while collaborating with global process owners and subject matter experts.