Quality Assurance Analyst

Quality Assurance Analyst – Ancera Job Description Employment Type: Full-time Work Location: On-site, Branford, CT (laboratory and office environment) About Ancera Ancera, based in Branford, Connecticut, builds supply-chain intelligence for the food industry, starting with microbial monitoring in poultry. Its PIPER platform combines molecular and classical microbiology with a time-to-result that fits plant and farm operations. Ancera captures microbial observation data, and integrates production trends and volumes of open-source intelligence. At the core of the platform, data science algorithms discover hidden patterns and provide simple, objective answers to food producers. Poultry integrators and retailers use the data to improve productivity, food safety and animal welfare. Position Overview The Quality Assurance (QA) Analyst is responsible for ensuring that Ancera’s laboratory consistently produces accurate, reliable, and defensible test results that meet regulatory requirements, accreditation standards, and customer expectations. Working closely with laboratory analysts, technical supervisors, client services, and food manufacturers, the QA Analyst maintains the laboratory quality management system, reviews testing data and records, investigates nonconformances, and verifies that corrective and preventative actions are effective. The QA Analyst serves as an advocate for quality and food safety, helping the laboratory protect public health, reduce risk, and maintain customer trust. Job Activity Description On a day-to-day basis, the QA Analyst reviews analytical and microbiological testing records, verifies that methods are performed according to approved standard operating procedures (SOPs), and confirms that results are accurately recorded and reported. The analyst monitors quality control (QC) data, proficiency testing, equipment calibration, and environmental monitoring records; investigates deviations, out-of-specification (OOS) results, and customer complaints; documents corrective and preventive actions (CAPA); and monitors CAPA implementation and determines effectiveness of corrective actions. The analyst also supports internal audits and external assessments by accreditation bodies, regulators, and customers. The role requires a balance of independent, detail-oriented review and active collaboration with laboratory staff and management, and contributes to continuous improvement by strengthening procedures, training, and data integrity practices. Key Responsibilities Quality System and Documentation Maintain and improve the laboratory quality management system in accordance with ISO/IEC 17025 and other applicable accreditation requirements. Write, review, and control SOPs, test methods, forms, and work instructions, ensuring they reflect current regulatory and method requirements. Manage document control, record retention, and version history for controlled documents and laboratory records. Maintain traceability among samples, methods, reagents, equipment, personnel training records, and reported results. Testing Oversight and Data Review Review raw data, worksheets, chain-of-custody records, and final reports for accuracy, completeness, and compliance with methods and SOPs. Verify results of microbiological, molecular, and biochemical assays before release to clients. Monitor QC samples, control charts, positive and negative controls, media and reagent performance, and trends in test data. Oversee proficiency testing programs and evaluate results and coordinate method validation and verification studies. Verify that technology transfer documentation meets production laboratory requirements and training records confirm proficiency of laboratory staff. Confirm that equipment calibration, maintenance, and temperature monitoring are performed and documented as required. Nonconformance, CAPA, and Reporting Investigate deviations, out-of-specification and unexpected results, retests, and customer complaints, documenting findings clearly and promptly. Lead root cause analysis and initiate, track, and verify the effectiveness of corrective and preventive actions (CAPA). Prepare and communicate quality metrics, trend reports, and audit results to laboratory leadership. Audits, Accreditation, and Regulatory Compliance Plan and conduct internal audits of laboratory processes, and host or support external audits by accreditation bodies, regulatory agencies, and customers. Ensure compliance with applicable requirements such as Good Laboratory Practices (GLP), FDA and USDA regulations, the Food Safety Modernization Act (FSMA), HACCP principles, and Global Food Safety Initiative (GFSI) schemes. Prepare audit responses and follow up on findings through closure. Maintain readiness for accreditation assessments, including management review inputs and risk and opportunity assessments. Training, Collaboration, and Continuous Improvement Develop and deliver training on quality procedures, good documentation practices, and data integrity, and verify staff competency and training records. Partner with laboratory analysts, supervisors, and client services to resolve quality questions and improve turnaround and reliability. Support the validation and maintenance of the laboratory information management system (LIMS) and electronic records, ensuring data integrity (ALCOA+ principles). Promote laboratory safety, biosafety, and sample-handling practices in coordination with safety personnel. Recommend and implement process improvements that increase quality, efficiency, and compliance. Education and Experience Education Bachelor's degree in Food Science, Microbiology, Biology, Chemistry, Biochemistry, or a related scientific field; or an equivalent combination of education and relevant work experience. Preferred: Certifications such as ASQ Certified Quality Auditor (CQA) or Certified Quality Manager, HACCP certification, Preventive Controls Qualified Individual (PCQI), or ISO/IEC 17025 internal auditor training. Experience 3-5years of experience in quality assurance, quality control, or regulatory compliance in food, beverage, dietary supplement, pharmaceutical, or related industry. Working knowledge of food safety and quality systems such as HACCP, GMP, FSMA, and GFSI schemes (e.g., SQF, BRCGS, FSSC 22000). Demonstrated experience writing and reviewing SOPs, conducting audits, and managing nonconformances and CAPA. Experience reviewing technical records and data, with a strong understanding of good documentation and data integrity practices. Experience using quality management software, document control systems, or a laboratory information management system (LIMS). Plus: Hands-on laboratory experience, such as food microbiology (e.g., pathogen detection, plate counts, PCR), analytical chemistry (e.g., HPLC, GC, ICP-MS), or sample preparation. Plus: Experience working in a laboratory accredited to ISO/IEC 17025. Skills and Competencies Technical Skills Strong knowledge of laboratory quality systems, including method validation and verification, measurement uncertainty, QC practices, and proficiency testing. Familiarity with food testing methods and laboratory techniques, such as microbiological culture methods, molecular testing, and chemical and allergen analysis. Understanding of statistical analysis, trending, and control charting for quality data. Knowledge of root cause analysis tools such as 5 Whys, fishbone diagrams, and failure mode analysis. Working knowledge of FDA, USDA, and other food safety regulations and laboratory accreditation requirements. Proficiency with Microsoft Office tools, especially Excel, Word, and Teams, and comfort learning LIMS and quality system software. Professional Skills Exceptional attention to detail and a methodical, analytical approach to problem solving. Clear written and verbal communication skills, with the ability to explain quality and compliance requirements to scientists, operators, and customers. Strong organizational and time-management skills, with the ability to manage multiple priorities and meet deadlines in a fast-paced laboratory. Integrity and sound judgment in handling sensitive data and making decisions that affect food safety. Collaborative, flexible, and able to work effectively both independently and as part of a team. Commitment to continuous learning, improvement, and a strong culture of quality and food safety. Working Conditions This position is based in a laboratory and office environment. The analyst divides time between reviewing records at a computer and observing laboratory operations, which may require wearing personal protective equipment (PPE) such as lab coats, gloves, and safety glasses, and following biosafety and chemical safety procedures. The role may involve exposure to food samples, chemicals, and biological materials, and may require standing or walking for extended periods and occasionally lifting up to 25 pounds. Occasional extended hours may be needed to support audits or time-sensitive testing, and limited travel may be required. #J-18808-Ljbffr BioCT