Job Title: Senior Quality Assurance Specialist
Department: Quality Assurance
Reporting to: Quality Assurance Manager
Location: Brookfield, Connecticut
Vacancy Status: This posting is for an existing vacancy.
The QA Senior Specialist provides experienced quality assurance and document management support in a GMP-regulated manufacturing environment. The role independently executes core QA activities, serves as a resource for batch records, labeling, document control, and quality systems, and leads investigations and continuous improvement efforts supporting compliance and product quality.
Who You Are:- High School Diploma or GED required; additional education or professional quality certification preferred.
- Minimum 3 years of progressive experience in Quality Assurance, document management, or manufacturing support within a regulated environment.
- Demonstrated experience with batch record review, material or product disposition, labeling control, document management, investigations, and audit support.
- Working knowledge of GMP and ISO-based quality systems; chemical, pharmaceutical, or industrial manufacturing experience preferred.
- Strong analytical, organizational, problem-solving, and communication skills, with the ability to work independently, manage competing priorities, and lead cross-functional activities.
Job Responsibilities: Document Management & Label Control- Issue and control labels, batch records, and other controlled documents supporting manufacturing and packaging operations.
- Create, revise, and maintain labeling masters, batch records, Work Instructions, procedures, inventories, and associated documentation.
- Lead labeling and document changes, including impact assessment, implementation, and cross-functional resolution of documentation issues.
Quality Assurance Operations- Review executed Batch Production Records for completeness, accuracy, compliance, and documentation of critical process steps and in-process checks.
- Perform final quality review and disposition of raw materials, intermediates, and finished products; review and approve Certificates of Analysis.
- Review inbound and outbound shipments and perform in-process evaluations to verify compliance with specifications and quality requirements.
- Provide quality guidance to operational departments and support coordination of daily QA activities.
Investigations, Audits & Compliance- Lead investigations of deviations, OOS results, complaints, and CAPAs, including root cause analysis and development of effective corrective and preventive actions.
- Conduct GMP audits of manufacturing, packaging, and warehouse operations and support regulatory, certification, and customer audits.
- Assess changes to processes, equipment, materials, and documentation to ensure appropriate risk assessment and validation requirements are addressed.
- Review quality and error data to identify recurring issues, systemic risks, and opportunities for improvement.
Continuous Improvement, Training & Metrics- Analyze quality trends and metrics, prepare reports, and lead or support site quality improvement initiatives.
- Maintain quality procedures for accuracy, compliance, and effectiveness and support GMP, SOP, quality system, and onboarding training.
- Serve as a technical and procedural mentor to junior QA personnel and lead cross-functional quality initiatives as assigned.
Total Compensation & Care: - Base salary dependent on experience and demonstrated performance
- Formal and informal training opportunities
- Comprehensive health and dental benefits
- Income protection: short- and long-term disability coverage, life insurance, paid personal sick time
- Vacation time exceeding industry standards
- Company funded retirement savings program with individual contribution opportunities
- Meaningful and challenging work
- Curated intentional culture focused on growth and development, engagement, and communication
