QA Operations Specialist I

Terrestrial Bio•Woburn, MA

7h•$60,000 - $80,000•Onsite

About The Position

The QA Operations Specialist I provides hands-on Quality Assurance support for day-to-day GMP operations across manufacturing, packaging, QC testing, materials, equipment, and facilities. The role supports accurate, compliant execution with patient safety in mind in a fast-paced combination product environment. Reporting to the Quality Assurance Manager, the specialist works closely with Manufacturing, Quality Control, R&D, Facilities, Materials Management, and external partners to review records, provide real-time Quality support, resolve issues, and maintain inspection readiness as Terrestrial's programs advance through clinical development. The position offers broad exposure to Quality operations and opportunities to develop technical knowledge and decision-making skills. Within the first 6–12 months, success means independently supporting routine Quality operations, completing accurate and timely record reviews, identifying and escalating issues appropriately, and becoming a trusted partner to supported teams. The specialist contributes to GMP manufacturing campaigns, facility and equipment readiness, material and batch disposition, investigations, change controls, and continuous improvement activities supporting clinical programs and planned site expansion. The role is based in Woburn, MA and at Terrestrial's new custom facility in Allston, MA, planned for Q4 2026. Candidates must be willing to work onsite 4–5 days per week.

Requirements

Strong attention to detail and ability to review technical records and identify missing, inaccurate, or inconsistent information.
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.
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.

Nice To Haves

Bachelor's degree in biology, chemistry, biochemistry, engineering, pharmaceutical sciences, or a related scientific or technical discipline.
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.

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.