GMP QA Operations Associate I

Terrestrial Bio; Walnut Hill (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 for day-to-day GMP operations across manufacturing, packaging, QC testing, materials, equipment, and facilities at our Allston and Woburn sites.

You will review records, support investigations, ensure data integrity, and help maintain inspection readiness as Terrestrial advances through development, reporting to the Quality Assurance Manager and collaborating with cross-functional teams.

Qualifications

• Bachelor’s degree in biology, chemistry, biochemistry, engineering, pharmaceutical sciences, or a related scientific or technical discipline preferred.
• 0-2+ years of experience in Quality Assurance, Quality Control, manufacturing, laboratory operations, engineering, or another regulated environment.
• Basic knowledge of current Good Manufacturing Practices, Good Documentation Practices, data integrity principles, and applicable requirements under 21 CFR Parts 4, 210, 211, and 820.
• Familiarity with analytical testing, laboratory documentation, specifications, analytical data review, and test method qualification or validation principles, including ICH Q2(R2).
• Experience in pharmaceutical, biotechnology, medical device, or combination product operations is preferred.

Responsibilities

• Provide day-to-day QA oversight of GMP manufacturing, packaging, QC testing, material handling, equipment, and facility activities.
• Perform on-the-floor Quality support, including line clearance, material and label verification, documentation review, and resolution of real-time GMP issues.
• Review batch records, analytical test records, equipment logbooks, environmental monitoring records, protocols, and reports for accuracy, completeness, data integrity, and GMP compliance.
• Review QC analytical data and test results, including calculations, instrument outputs, specifications, and supporting documentation, to ensure results are scientifically sound and properly documented.
• Review and support analytical test method qualification, validation, verification, and transfer protocols and reports in accordance with approved procedures and applicable guidance, including ICH Q2(R2).
• Support incoming material inspection, batch disposition, label issuance and reconciliation, and controlled document activities.
• Support deviations, nonconformances, OOS/OOT results, complaints, and environmental monitoring excursions, including investigations, impact assessments, root cause analysis, and CAPA follow-up.
• Review and support change controls involving manufacturing processes, analytical methods, specifications, materials, equipment, facilities, suppliers, and combination product operations.
• Support equipment lifecycle and facility activities, including calibration, maintenance, qualification, logbook control, environmental monitoring, and equipment status.
• Collaborate with Manufacturing, Quality Control, R&D, Facilities, Materials Management, and external partners to resolve Quality issues and maintain inspection readiness.

Skills

Attention to detail

Written communication

Cross-functional collaboration

Education

B.S. in biology

Job description

Terrestrial Bio, Inc. is seeking a Quality Operations Specialist I to provide hands-on QA support for day-to-day GMP operations across manufacturing, packaging, QC testing, materials, equipment, and facilities at our Allston and Woburn sites.

You will review records, support investigations, ensure data integrity, and help maintain inspection readiness as Terrestrial advances through development, reporting to the Quality Assurance Manager and collaborating with cross-functional teams.