Quality Specialist

• Serve as a technical resource and Subject Matter Expert for QC Microbiology laboratory operations, microbiological methods, and testing programs
• Evaluate, implement, and support new or revised microbiological methods, laboratory procedures, equipment, software applications, and reporting tools
• Lead and support laboratory studies, protocols, troubleshooting efforts, and technical assessments
• Represent QC Microbiology on cross-functional teams and project initiatives
• Lead and support complex laboratory investigations, deviations, non-conformances, and root cause analyses
• Perform data gathering, trend analysis, and technical assessments to support investigations and business decisions
• Initiate, execute, and close quality system records including Change Controls, CAPAs, deviations, and document revisions
• Ensure investigations and quality system activities comply with cGMP requirements, company procedures, and regulatory expectations
• Author, revise, and review SOPs, technical reports, protocols, risk assessments, and other controlled documents
• Facilitate inspection readiness activities and participate in internal audits, regulatory inspections, and client audits
• Monitor regulatory and technical updates and incorporate applicable changes into laboratory procedures and practices
• Ensure laboratory activities, documentation, and data integrity practices remain compliant with regulations and industry standards
• Monitor and analyze laboratory performance metrics and KPIs
• Identify and implement process improvements to enhance efficiency, compliance, data quality, and laboratory performance
• Support strategic initiatives improving microbiology testing, sampling programs, and laboratory operations
• Collaborate with internal stakeholders and external partners to resolve technical and operational challenges

Quality Specialist jobs in New York

Quality Control Microbiology Specialist