Senior QA Specialist: GMP Compliance & Investigations

Greenfield Global Inc.; Stony Hill (CT); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Health insurance

Dental benefits

Retirement plan

Paid time off

Job summary

Greenfield Global Inc. is seeking a Senior Quality Assurance Specialist to join a GMP-regulated manufacturing team in Brookfield, CT.

The role involves independent QA activities, batch record support, labeling control, document management, and driving investigations & continuous improvement to ensure product quality. Candidates should have 3+ years in QA, with strong analytical and cross-functional collaboration skills.

Qualifications

• Experience in a GMP-regulated manufacturing environment.
• Batch record review, labeling control and document management.
• Investigations, audits, and CAPA experience.

Responsibilities

• Issue and control labels, batch records and controlled documents.
• Review Batch Production Records for completeness and compliance.
• Disposition of materials and finished products; Certificates of Analysis review.
• Lead investigations of deviations, OOS results, and CAPAs.

Skills

Quality Assurance

Document management

Batch records

Label control

Investigations

Audits

GMP

ISO quality systems

Cross-functional leadership

Education

High School Diploma or GED

Quality certification (preferred)

Job description

Greenfield Global Inc. is seeking a Senior Quality Assurance Specialist to join a GMP-regulated manufacturing team in Brookfield, CT.

The role involves independent QA activities, batch record support, labeling control, document management, and driving investigations & continuous improvement to ensure product quality. Candidates should have 3+ years in QA, with strong analytical and cross-functional collaboration skills.