Senior Quality Assurance Specialist

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Production Wilmington, MA, US

Salary Range: $90,000.00 To $ Annually

Job Title:

Senior Quality Assurance Specialist

Department:

Quality Assurance

Reports To:

Quality Director

This position supports the Quality Assurance system of Eckert & Ziegler Radiopharma, Inc. (EZRI) in Wilmington, Massachusetts, covering GMP manufacturing of radio labeled drug products for early clinical phase programs and GMP and non-GMP radionuclide manufacturing. Working under the Quality Director and in coordination with Eckert & Ziegler Radiopharma GmbH (Germany), the QA Specialist owns documentation and good documentation practices, provides QA oversight of equipment qualification and calibration, supports inventory and material control, and supports testing, Certificate of Analysis (CoA) review, and product disposition and release under delegated authority.

Given the short radioactive half-lives of these products, the role supports rapid and real-time release so that disposition occurs within the usable shelf life, and maintains a clear, defensible boundary between GMP drug-product activities and non-GMP isotope activities. The QA Specialist verifies that current procedures are followed, delivers GMP training, and keeps leadership informed on the status of QA activities.

1. Documentation & Good Documentation Practices

• Own the QA documentation system — controlled SOPs, batch records, logbooks, forms, and specifications — including issuance, review, revision, and archival.
• Establish and enforce good documentation practices (GDP) and ALCOA+ data integrity across manual and instrument-generated GMP records.
• Perform batch record and executed-document review for completeness, accuracy, and compliance prior to disposition.
• Maintain document control, change control, and record-retention systems appropriate to clinical phase.
• Maintain files on current suppliers, training programs, and audit/inspection results.

2. Equipment Qualification & Calibration Oversight

• Provide QA oversight of equipment and instrument qualification (IQ/OQ/PQ), requalification, and the calibration program, ensuring equipment remains qualified, within tolerance, and on schedule.
• Review and approve qualification and calibration protocols, results, and associated deviations.

3. Inventory & Material Control

• Support inventory and material control for incoming raw materials and components.
• Ensure proper labeling and control of material.
• Ensure labeling and traceability across GMP and non-GMP materials.
• Support supplier and vendor qualification and monitoring, including approved-supplier records and incoming-material specifications.

4. Testing, Release & Product Disposition

• Support release testing of radio labeled drug products and radionuclides, coordinating rapid and real-time release within half-life-constrained windows.
• Review Certificates of Analysis and analytical data supporting product disposition.
• Perform or support product disposition and release/reject decisions in accordance with approved specifications, procedures, and delegated release authority.
• Coordinate testing and release schedules with Manufacturing and QC to meet time-critical dispensing and shipment windows.

5. GMP Training, Compliance & Quality Systems

• Develop and deliver GMP and good documentation practice training and maintain training records and qualification.
• Assure compliance with company Quality Assurance standards and phase-appropriate GMP.
• Monitor current and emerging cGMP regulations, guidelines, and industry best practices, and drive their adoption into procedures,…