Quality Assurance Specialist

4 weeks ago

Nyack, United States gonzer Full time
Quality Assurance Specialist

Key Responsibilities:
Assist in the implementation and maintenance of robust quality systems and processes
Manage user database, DMR database, and processes to closure
Issue SCARs to suppliers, follow through to completion
Change quality status in ERP as needed
Issue nonconformances, CAPAs, Deviations, Conditional Releases as needed
Maintain applicable SOPs and processes

Document Processing:
Review change requests and documentation for compliance
Process change requests and documents for review, approval, and issuance
Ensure revision control of all controlled documents

Customer Service:
Assist internal customers with technical support and status inquiries

Filing:
File controlled documents as needed per procedure

Reporting & Analysis:
Create weekly trending reports and metrics for complaints, nonconformances/DMRs, and others as appropriate
Deliver departmental metrics as requested
Analyze and plan upgrade strategies to ensure compliance

Audits, Inspections, and Commitments:
Participate in the organization and execution of audits and inspections, including personnel, requests, documentation, and process flow
Maintain documentation and records in accordance with regulations and internal policies

Requirements:
Associate's Degree preferred
At least 3 years in a Quality role in a GMP environment
Proficient in Microsoft Office Suite, Internet Browsers, and Adobe PDF applications
Document control System, CAPA/Compliant Investigation, SAP working knowledge preferred
Ability to prioritize daily workload, multitask, and shift scope to meet business needs
Ability to work independently, cross-functionality, and within a team environment
Possesses a strong attention to detail and the ability to troubleshoot documentation issues with minimal guidance
Ability to participate effectively in audits and inspections

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