Details: L.J Gonzer Associates is looking for individuals to join our pool of qualified candidates for potential assignment as a Quality Assurance Coordinator with our client based in West Nyack, NY. This position will perpetuate Enterprise-wide Quality and Regulatory compliance and continuous improvement through assisting with the implementation and maintenance of robust quality systems and processes. This position will report to the Senior Manager of Quality Assurance. System Management:
- Keep user database current (CAPAs, Change Control, Deviations, Customer Complaints)
- Manage DMR database and processes to closure
- Issue SCARs (Supplier Corrective Actions Investigations) to suppliers, follow through to completion
- Change quality status in ERP (SAP) as needed
- Issue nonconformances, CAPAs, Deviations, Conditional Releases as needed in support of the Quality System
- Maintain applicable SOPs and processes
- Participate in and provide necessary data/metrics required for Quality meetings
- Assist in investigations by review of batch records retain analysis, and Gemba walks
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
- Purge obsolete documents per procedure
Customer Service:
- Assist internal customers with technical support and status inquires
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
Job RequirementsDetails:
- Associate's Degree preferred. Relative work experience in a GMP environment may be considered in lieu of degree
- 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