Senior Quality Assurance Specialist

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Senior Quality Assurance Specialist

Production Wilmington, MA, US

2 days ago Requisition ID: 1032

Salary Range: $90,000.00 To $110,000.00 Annually

Job Title:

Senior Quality Assurance Specialist

Department:

Quality Assurance

Reports To:

Quality Director

Position Summary

This position supports the Quality Assurance system of Eckert & Ziegler Radiopharma, Inc. (EZRI) in Wilmington, Massachusetts, covering GMP manufacturing of radiolabeled 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.

Key Responsibilities

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 radiolabeled 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, systems, and training.
• Maintain clear procedural separation between GMP drug-product and non-GMP isotope activities, records, and materials.
• Support deviations, CAPA, change control, product quality complaint handling, and recall readiness; participate in the self-inspection (internal audit) program and support regulatory and client audits.
• Perform other duties as assigned by management.

Key Performance Expectations

• Maintain documentation accuracy and good documentation practices across all GMP records and batch records.
• Certificate of Analysis review and product disposition completed accurately and within half-life-constrained release windows.
• Equipment qualification and calibration maintained on schedule and within tolerance.
• GMP training delivered and kept current.
• Phase-appropriate GMP, data integrity, and the GMP/non-GMP isotope boundary maintained with minimal audit and inspection findings.

Supervisory Responsibilities

• No supervisory responsibilities

Required Skills & Qualifications

• Bachelor’s degree in Chemistry, Radiochemistry, Pharmaceutical Sciences, Biology, or a related scientific field.
• 5+ years of Quality Assurance experience in a GMP pharmaceutical or radiopharmaceutical environment, covering GMP radiolabeling of early clinical phase drug products and GMP/non-GMP radionuclide manufacturing.
• Working knowledge of phase-appropriate GMP, good documentation practices, ALCOA+ data integrity, and current and emerging cGMP regulations, guidelines, and best practices.
• Experience with document control, batch record review, CoA review and product disposition/release, and QA oversight of equipment qualification (IQ/OQ/PQ) and calibration.
• Familiarity with short-half-life radiopharmaceutical products and rapid or real-time release preferred.
• Comfortable working in, and gowning to enter, controlled areas where radioactive materials are present, with awareness of applicable radiation safety requirements (e.g., ALARA); direct handling of radioactive materials is not required.
• Proficiency with paper and electronic QMS systems and Microsoft Office.
• Strong communication, organizational, and cross-functional collaboration skills, with excellent attention to detail.

Work Schedule & Conditions

• On-site role based in Wilmington, Massachusetts; full time, Monday-Friday.
• Requires flexibility beyond standard weekday hours - including early mornings, evenings, weekends, and holidays - to support business critical activities.
• Work in and around GMP manufacturing, laboratory, and radioactive-materials areas.
• Does not directly handle radioactive materials, but must be comfortable gowning into required personal protective equipment (PPE) to enter controlled manufacturing and laboratory areas where radioactive materials are present; must wear radiation dosimetry as assigned and comply with radiation safety and ALARA requirements.
• Must be able to stand for extended periods and lift up to 25 lbs. and walk up and down stairs to access office areas.

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