QA Operations Specialist

Terrestrial is building a team of exceptional people to rapidly advance products to patients. We work closely as a team and thrive in a dynamic, exciting, and engaging work environment. We aim to recruit, employ, train, compensate and promote regardless of race, religion, color, national origin, sex, gender identity or expression, sexual orientation, disability, age, or veteran status.

Please note:

We have been made aware that individuals unaffiliated with Terrestrial have posed as hiring managers to solicit personal information. Terrestrial does not conduct any recruiting through online chat services or message boards. Terrestrial does not request any personal financial information before an on-site interview. Please use care and discretion when receiving any solicitations that do not originate from the  domain.

Woburn, MA

30 Cummings Park Dr, Woburn, MA, 01801

Full time

On-site

Quality

Terrestrial Bio

Location:

Allston, MA and Woburn, MA

About Terrestrial Bio, Inc.

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  .

Why this role

The Quality Operations Specialist 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.

What you'll do

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…