QA Operations Specialist

About Terrestrial Bio, Inc.

Terrestrial is transforming the delivery of next-generation therapies, starting with GLP-1.

Location:

Allston, MA and Woburn, MA

Terrestrial is transforming the delivery of next-generation therapies, starting with GLP-1.

Terrestrial's proprietary Tacterra™ microarray patch (MAP) and applicator platform consists of a patch resembling an adhesive bandage, which is applied with a preloaded applicator and removed after a few minutes. Once applied, each patch delivers bioactive tips into the skin, which dissolve quickly into the body, rapidly releasing their therapeutic payload. Designed for self-administration, the temperature-stable Tacterra™ platform enables precise, controlled delivery of a wide range of therapeutics without medical sharps or refrigeration.

Terrestrial has generated strong clinical and in-vivo proof of concept across multiple molecules. For more information, visit

The Quality Operations Specialist I will provide hands-on QA support for day-to-day GMP operations across manufacturing, packaging, QC testing, materials, equipment, and facilities. This role offers the opportunity to build broad Quality experience in a fast-paced combination product environment while helping ensure activities are performed accurately, compliantly, and with patient safety in mind. Reporting to the Quality Assurance Manager, this role works closely with Manufacturing, Quality Control, R&D, Facilities, and Materials Management to review records, provide real-time Quality support, resolve issues, and maintain inspection readiness as Terrestrial’s programs advance through clinical development.

• 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, 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.

You will be a visible, hands-on Quality partner who helps teams execute GMP activities correctly and resolve issues in real time. The role provides exposure to a broad range of Quality operations and opportunities to grow your technical knowledge and decision-making skills.

• Within the first 6–12 months, success will mean…