Senior Quality Assurance Specialist

Greenfield Global Inc. • Brookfield, CT

10d • Onsite

About The Position

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.

Requirements

• High School Diploma or GED required
• 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
• Strong analytical, organizational, problem-solving, and communication skills, with the ability to work independently, manage competing priorities, and lead cross-functional activities.

Nice To Haves

• additional education or professional quality certification preferred
• chemical, pharmaceutical, or industrial manufacturing experience preferred

Responsibilities

• 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.
• 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.
• 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.
• 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.

Benefits

• 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
• Formal and informal training opportunities

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: High school or GED