Senior Quality Assurance Specialist

Eckert & Ziegler Radiopharma Inc • Wilmington, MA

4d • $90,000 - $110,000 • Onsite

About The Position

The Senior Quality Assurance Specialist supports the Quality Assurance system at Eckert & Ziegler Radiopharma, Inc. in Wilmington, Massachusetts, covering GMP manufacturing of radiolabeled drug products for early clinical phase programs and GMP and non-GMP radionuclide manufacturing. The position works under the Quality Director and coordinates with Eckert & Ziegler Radiopharma GmbH in Germany.

The specialist owns QA documentation and good documentation practices; provides QA oversight of equipment qualification and calibration; supports inventory and material control; and supports testing, Certificate of Analysis review, and product disposition and release under delegated authority. Because the products have short radioactive half-lives, the role supports rapid, real-time release within their usable shelf life. It also maintains a clear, defensible separation between GMP drug-product activities and non-GMP isotope activities. The specialist verifies that current procedures are followed, delivers GMP training, and keeps leadership informed about QA activities.

This is a full-time, on-site role in Wilmington, Massachusetts, with a Monday–Friday schedule and flexibility beyond standard weekday hours, including early mornings, evenings, weekends, and holidays, to support business-critical activities. The work takes place in and around GMP manufacturing, laboratory, and radioactive-materials areas. Direct handling of radioactive materials is not required, but the employee must be comfortable gowning in required PPE, wearing assigned radiation dosimetry, and complying with radiation safety and ALARA requirements. The position requires standing for extended periods, lifting up to 25 pounds, and walking up and down stairs.

Requirements

• Bachelor’s degree in Chemistry, Radiochemistry, Pharmaceutical Sciences, Biology, or a related scientific field.
• At least 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.
• Proficiency with paper and electronic QMS systems and Microsoft Office.
• Strong communication, organizational, and cross-functional collaboration skills, with excellent attention to detail.
• Comfort working in and gowning to enter controlled areas where radioactive materials are present, with awareness of applicable radiation safety requirements such as ALARA; direct handling of radioactive materials is not required.
• Ability to work beyond standard weekday hours, including early mornings, evenings, weekends, and holidays, as needed for business-critical activities.
• Ability to stand for extended periods, lift up to 25 pounds, and walk up and down stairs.
• Must wear radiation dosimetry as assigned and comply with radiation safety and ALARA requirements.

Nice To Haves

• Familiarity with short-half-life radiopharmaceutical products and rapid or real-time release.

Responsibilities

• Own the QA documentation system, including controlled SOPs, batch records, logbooks, forms, and specifications, and manage issuance, review, revision, and archival.
• Establish and enforce good documentation practices and ALCOA+ data integrity across manual and instrument-generated GMP records.
• Review batch records and executed documents for completeness, accuracy, and compliance before disposition.
• Maintain document control, change control, and record-retention systems appropriate to clinical phase.
• Maintain files on current suppliers, training programs, and audit and inspection results.
• Provide QA oversight of equipment and instrument qualification (IQ/OQ/PQ), requalification, and calibration programs; ensure equipment remains qualified, within tolerance, and on schedule.
• Review and approve qualification and calibration protocols, results, and associated deviations.
• Support inventory and material control for incoming raw materials and components; ensure proper labeling and control of materials and traceability across GMP and non-GMP materials.
• Support supplier and vendor qualification and monitoring, including approved-supplier records and incoming-material specifications.
• 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 or 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.
• Develop and deliver GMP and good documentation practice training; maintain training records and qualification.
• Assure compliance with company QA 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 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 program and support regulatory and client audits.
• Perform other duties as assigned by management.

What This Job Offers

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