Quality Assurance Auditor at LJ Gonzer Associates

L.J Gonzer Associates is looking for individuals to join our pool of qualified candidates for potential assignment as a Quality Assurance Auditor based in West Nyack, NY with our client, an expanding cosmetics manufacturer. In this long-term contract role, you'll be responsible for the quality, regulatory compliance, and continuous improvement through assisting with the implementation and maintenance of robust quality systems and processes.

Job Duties:

• Keep user database current (CAPAs, Change Control, Deviations, Customer Complaints)
• Manage DMR database and processes to closure
• Change quality status in ERP (SAP) as needed
• Maintain applicable SOPs and processes
• Review change requests and documentation for compliance
• Process change requests and documentations for review, approval, and issuance
• Ensure revision control of all controlled documents
• Assist internal customers with technical support and status inquiries
• Create weekly trending reports and metrics for complaints, nonconformances/DMRs, and others as appropriate
• Participate in the organization and execution of audits and inspections, including personnel, requests, documentation, and process flow

Qualifications:

• Associate's Degree preferred. Experience in a GMP environment may be considered in lieu of degree
• SAP working knowledge 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
• Ability to prioritize daily workload, multitask, and shift scope to meet business needs
• Ability to work independently, cross-functionally, and within a team environment
• Possess a strong attention to detail and the ability to troubleshoot documentation issues with minimal guidance
• Ability to participate effectively in audits and inspections

L.J. Gonzer Associates is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.