Senior QA Specialist, Radiopharma & Real-Time Release

Eckert & Ziegler Radiopharma Inc; Wilmington (MA); On-site; USD 90,000 - 110,000; Full time

Job summary

Eckert & Ziegler Radiopharma Inc in Wilmington, MA is seeking a Senior Quality Assurance Specialist to own the QA documentation system, ensure GDP/ALCOA+ data integrity, and support rapid real-time release of radiopharmaceuticals for early clinical programs.

This on-site role collaborates with QA, Manufacturing, QC and regulatory teams, performing COA reviews, batch-record oversight, supplier qualification, training, and audits while maintaining ALARA safety standards.

Qualifications

• Bachelor's degree in a relevant scientific field required.
• 5+ years of QA experience in GMP radiopharmaceuticals or related field.
• Strong knowledge of GDP, ALCOA+ data integrity, and cGMP regulations.
• Experience with document control, batch record review, and QA oversight.
• Familiarity with short half-life radiopharmaceutical products and real-time release.

Responsibilities

• Own the QA documentation system: SOPs, batch records, forms, and specifications.
• Enforce GDP and ALCOA+ data integrity across GMP records.
• Review batch records and COA for disposition under approved specs.
• Oversee equipment qualification (IQ/OQ/PQ) and calibration programs.
• Support inventory/Material control and supplier qualification.
• Coordinate release testing and quick disposition within half-life constraints.
• Deliver GMP training and maintain training records; aid internal audits.

Skills

GMP QA oversight

ALCOA+ data integrity

Documentation management

CoA review

IQ/OQ/PQ equipment qualification

Regulatory/compliance knowledge

Education

Bachelor’s degree in Chemistry/Radiochemistry/Pharmaceutical Sciences

Tools

QMS systems

Microsoft Office

Job description

Eckert & Ziegler Radiopharma Inc in Wilmington, MA is seeking a Senior Quality Assurance Specialist to own the QA documentation system, ensure GDP/ALCOA+ data integrity, and support rapid real-time release of radiopharmaceuticals for early clinical programs.

This on-site role collaborates with QA, Manufacturing, QC and regulatory teams, performing COA reviews, batch-record oversight, supplier qualification, training, and audits while maintaining ALARA safety standards.