Quality Assurance Specialist
About the job
- A minimum Bachelor of Science degree in a technical discipline, such as Chemical or Biological Sciences.
- At least 3 years of experience in an auditor role in an ISO 17025-accredited, GLP- and/or GMP-regulated environment, with proficiency in quality assurance systems and documentation.
- Technical experience using and calibrating analytical instrumentation commonly found in a commercial laboratory.
- Proficiency in written and spoken English.
- Proficiency in Microsoft Office, including Excel, Outlook, and Word; computer literacy; and familiarity with IT systems, electronic submission systems, and data and document management systems.
- Design, develop, and implement internal auditing programs and procedures consistent with organizational requirements.
- Perform internal audits to ensure procedures are available and followed in accordance with requirements for maintaining ISO/IEC 17025:2017 accreditation and GLP recognition.
- Perform GLP inspections to ensure GLP studies meet OECD and/or FDA GLP requirements.
- Report audit findings to the Director of Quality Assurance or designate, and conduct post-audit meetings as necessary.
- Perform and review non-conformance investigations to ensure issues are addressed and fully and properly resolved in documentation.
- Issue corrective actions in response to quality systems activities, track progress, and verify implementation and effectiveness.
- Evaluate supplier quality.
- Arrange and prepare for external audits, assist with pre- and post-assessment activities, coordinate actions on audit findings and corrective/preventive actions, and respond to related external findings.
- Review and evaluate laboratory performance in proficiency testing and inter-laboratory studies.
- Coordinate and perform refresher training on ISO 17025 and GMP for laboratory staff.
- Report quality metrics regularly to top management.
- Take responsibility for assigned quality projects.
- Schedule and perform internal audits and participate in external audits.
- Review and investigate non-conformances and client complaints.
- Issue and monitor corrective actions.
- Review, approve, and maintain equipment qualification records.
- Perform administrative tasks.
- Implement the Laboratory Quality Policy and perform duties in accordance with applicable job-specific requirements and procedures.
- Comply with health and safety policies and procedures, and wear required personal protective equipment while in the laboratory.
- Perform other duties as assigned.
- Excellent attention to detail, organizational, prioritization, and problem-solving skills.
- Excellent communication and conflict-resolution skills.
About the company
Certified Group provides laboratory testing, regulatory consulting, and certification services for regulated industries in North America, supported by a network of more than 30 laboratories. Its services cover microbiology and chemistry testing, regulatory guidance for FDA/USDA compliance, and third‑party audits and certification, including GFSI standards and animal welfare programs, delivered through its brands such as FSNS, Certified Laboratories, EAS Consulting Group, and Labstat. The group combines testing capabilities with advisory and certification expertise, growing its footprint through strategic acquisitions to offer wide coverage across food safety, dietary supplements, cosmetics, OTC drugs, nicotine products, and cannabis. Its goal is to help clients ensure product safety and regulatory compliance while expanding its business, with revenue around $300 million and ongoing consolidation in the sector.
Company Size
1,001-5,000
Company Stage
N/A
Total Funding
N/A
Headquarters
Town of Huntington, New York
Founded
2019
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Simplify's Take
What believers are saying
- Mérieux signed August 18, 2026 to acquire Certified Group, validating strategic value.
- Peugeot Invest and Conti financed the transaction on September 21, 2026.
- FSNS won Sodexo supplier audit approval on June 17, 2026, expanding recurring audit revenue.
What critics are saying
- The Mérieux deal closes by Q4 2026, ending Certified Group as an independent employer.
- Integration into Mérieux flattens brands, duplicates roles, and shifts investment decisions to Lyon.
- Tobacco, cannabis, and import-testing revenues face FDA rule changes and product-cycle volatility.
What makes Certified Group unique
- Certified Group runs 31 North American labs across food, cosmetics, nicotine, cannabis.
- Labstat earned OECD GLP recognition on May 13, 2026, strengthening nicotine CRO credibility.
- FSNS Green Bay passed A2LA ISO/IEC 17025 audit on June 8, 2026, with zero deficiencies.
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Benefits
- Flexible Work Hours