GMP QA Operations Specialist

Terrestrial; Woburn (MA); On-site; USD 60,000 - 80,000; Full time

Job summary

Terrestrial Bio, Inc. is seeking a Quality Operations Specialist I to provide hands-on QA support across GMP manufacturing, packaging, QC testing, materials, and facilities.

You will review records, resolve GMP issues in real time, and maintain inspection readiness while collaborating with Manufacturing, R&D, and Facilities. The role emphasizes attention to detail, documentation integrity, and cross-functional teamwork in a fast-paced, combination product environment.

Qualifications

• Bachelor’s degree in biology, chemistry, biochemistry, engineering, pharmaceutical sciences, or a related scientific or technical discipline.
• Strong attention to detail and ability to review complex records for accuracy.

Responsibilities

• Provide day-to-day QA oversight of GMP manufacturing, packaging, QC testing, material handling, equipment, and facility activities.
• Perform on-the-floor QA support, including line clearance, material and label verification, documentation review, and real-time GMP issue resolution.
• Review batch records, analytical test records, equipment logbooks, environmental monitoring records, protocols, and reports for accuracy and GMP compliance.
• Review QC analytical data and test results to ensure sound, properly documented results.
• Support change controls and investigations, CAPA follow-up, and environmental monitoring deviations.
• Collaborate with cross-functional teams to resolve quality issues and maintain inspection readiness.

Skills

Attention to detail

Cross-functional collaboration

Written communication

Prioritization

Education

Bachelor’s degree in biology or related field

Job description

Terrestrial Bio, Inc. is seeking a Quality Operations Specialist I to provide hands-on QA support across GMP manufacturing, packaging, QC testing, materials, and facilities.

You will review records, resolve GMP issues in real time, and maintain inspection readiness while collaborating with Manufacturing, R&D, and Facilities. The role emphasizes attention to detail, documentation integrity, and cross-functional teamwork in a fast-paced, combination product environment.