High School Diploma or GED required; additional education or certification preferred.
3+ years' experience in Quality Assurance, document management, or manufacturing in a regulated environment.
Experience with batch record review, document control, and quality system operations.
Knowledge of GMP and ISO quality systems; experience in chemical, pharmaceutical, or industrial manufacturing preferred.
Strong analytical, organizational, and communication skills, with ability to manage competing priorities.
Responsibilities
Issue and control labeling and batch records for manufacturing and packaging operations.
Create and maintain documentation like labeling masters, batch records, and procedures.
Lead changes in labeling and documentation, assessing impacts and resolving issues.
Review Batch Production Records for accuracy and compliance with critical processes.
Perform final quality reviews and dispositions of materials and products.
Conduct investigations of deviations and develop root cause analyses and corrective actions.
Lead GMP audits and support regulatory and customer audits.
Benefits
Formal and informal training opportunities.
Comprehensive health and dental benefits.
Short- and long-term disability coverage and life insurance.
Paid personal sick time and extensive vacation time.
Company-funded retirement savings program with contribution options.
Work in a culture focused on growth, engagement, and communication.
Full Job Description
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
