QA Operations Specialist I

Terrestrial Bio • Woburn, MA

2d • $60,000 - $80,000 • Onsite

About The Position

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.

Requirements

• Strong attention to detail with the ability to review technical records and identify missing, inaccurate, or inconsistent information required.
• 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.
• 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 preferred
• 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.

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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level