QA Operations Specialist I Terrestrial Bio Woburn, MA Job Details Full-time $60,000 - $80,000 a year 7 hours ago Qualifications Data integrity assurance Biology Biotechnology Raw material quality management Biochemistry Quality records maintenance Defect resolution root cause analysis Laboratory equipment routine checks Monitoring compliance data Pharmaceutical laboratory environment Pharmaceutical regulatory compliance Labeling Production deviation management Good documentation practices (GDP) Corrective and preventive actions (CAPA) GMP Incident Escalation Internal investigations Laboratory equipment calibration Bachelor's degree in biology Manufacturing facility experience Collaboration with product development teams ICH guidelines Quality assurance in testing Laboratory quality control records management Bachelor's degree in engineering Maintenance records management Continuous improvement Pharmaceutical company experience Decision making

Full Job Description 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 www.terrestrialbio.com. Why this role 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. 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 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. How you'll impact 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 independently supporting routine Quality operations, completing accurate and timely record reviews, identifying and escalating issues appropriately, and becoming a trusted partner to the teams you support. You will contribute to GMP manufacturing campaigns, facility and equipment readiness, material and batch disposition, investigations, change controls, and continuous improvement activities supporting Terrestrial's clinical programs and planned site expansion. Your attention to detail, willingness to learn, sound judgment, and collaborative approach will strengthen day-to-day Quality operations and help Terrestrial build scalable, inspection-ready systems as the company grows. Who you are Strong attention to detail with the ability to review technical records and identify missing, inaccurate, or inconsistent information required. 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), is preferred. Experience in pharmaceutical, biotechnology, medical device, or combination product operations is preferred. Strong organizational, written communication, and cross-functional collaboration skills. Ability to manage multiple priorities, follow established procedures, apply scientific judgment, and escalate issues appropriately in a fast-paced environment.

Compensation:

The anticipated base salary range for this position is $60,000 - $80,000 . Actual compensation will be determined based on a variety of factors including experience, qualifications, and internal equity.

Onsite expectations:

The majority of our roles at Terrestrial are either onsite or hybrid, which allows us to meet both business and team needs. Candidates applying must be willing to be onsite 4-5 days per week.

Location:

Woburn, MA and our new, custom facility in Allston MA planned for Q4 of 2026. At Terrestrial, we're bringing together exceptional talent to drive our product development forward. We value collaboration, curiosity, and a dynamic 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.