Senior Radiopharma QC Lead - Real-Time Release & Compliance

Eckert & Ziegler Radiopharma Inc; Wilmington (MA); Sur place; USD 90 000 - 110 000; Plein temps

Résumé du poste

Eckert & Ziegler Radiopharma Inc in Wilmington, MA seeks a Senior Quality Control Specialist (Lead) to perform analytical, microbiological, and release testing for radiochemical products, ensuring rapid real-time release within short half-lives and GMP-compliant documentation.

The role collaborates with Manufacturing, QA, and capital projects, supports CMO operations, and requires a strong background in radiopharmaceutical QC, ALCOA+ data integrity, and on-site work in a regulated lab.

Qualifications

• Bachelor’s degree (Master’s preferred) in Chemistry, Radiochemistry, Biochemistry, Microbiology, Pharmaceutical Sciences, Nuclear Chemistry, or a related scientific field.
• 5-8 years of QC experience in a GMP pharmaceutical, radiopharmaceutical, or regulated manufacturing environment, including working knowledge of phase-appropriate GMP and analytical and microbiological QC.
• Hands-on experience with radiopharmaceutical QC methods, including radiochemical purity, radionuclidic identity and purity, HPLC, dose calibration, bacterial endotoxin (LAL), and sterility.
• Experience with short-half-life products and rapid or real-time release testing strongly preferred.
• Experience supporting CMO/contract manufacturing operations, technology transfer, and quality agreements.
• Experience supporting capital projects, commissioning and qualification (C&Q), and new equipment or facility start-up preferred.
• Working knowledge of deviations, OOS/OOT investigations, CAPA, change control, and data integrity (ALCOA+).
• Familiarity with handling radioactive materials and applicable radiation safety requirements (e.g., NRC or Agreement State licensing and ALARA).
• Proficiency with laboratory data systems (LIMS or electronic records) and Microsoft Excel, PowerPoint, and Word.
• Strong communication, organizational, and cross-functional collaboration skills.
• Ability to work on-site in Wilmington, Massachusetts, with flexibility for time-critical testing.

Responsabilités

• Perform QC release testing of radiochemical and radiopharmaceutical products.
• Execute rapid and real-time release testing so that release decisions are completed within the product’s usable shelf life given short half-lives.
• Follow established testing sequences, retain-sample handling, and decay-corrected reporting of analytical results.
• Review analytical data and Certificates of Analysis and support Quality Assurance in final product release.
• Coordinate testing schedules with Manufacturing to meet time-critical calibration, dispensing, and shipment windows.
• Perform environmental monitoring of GMP classified and aseptic areas, including viable and non-viable, personnel, and surface monitoring.
• Track and trend environmental monitoring data, and support investigation of excursions, adverse trends, and associated corrective actions.
• Perform and support equipment and instrument qualification (IQ/OQ/PQ) and requalification for QC and manufacturing equipment.
• Perform calibration and routine maintenance of analytical instruments (balances, pipettes, HPLC, GC, ICP, and dose calibrators), ensuring instruments and equipment remain within tolerance and on schedule.
• Track incoming raw materials and components from receipt through sampling, testing, and disposition.
• Perform identity and quality testing of incoming materials against approved specifications.
• Perform incoming materials receipt and testing, applying quarantine, released, or rejected status labeling and controls per procedures.
• Perform routine QC support to Manufacturing, including in-process testing, sampling, and bioburden, endotoxin, and sterility testing appropriate to short-half-life products.
• Partner with Manufacturing, Supply Chain, and QA on batch record review, in-process/release limits, and material investigations.
• Provide QC support to the site’s internal CMO manufacturing operations, including GMP testing performed at EZRI for client and sponsor programs.
• Support technology and method transfer of analytical methods, specifications, and processes into the site — including for new products and expanded manufacturing capacity — with associated qualification and comparability.
• Assist with phase-appropriate qualification and validation of radiopharmaceutical test methods.
• Support capital and facility expansion projects, including QC input to user requirements, commissioning and qualification (C&Q), and equipment and area qualification (FAT/SAT, IQ/OQ/PQ).
• Support stability programs, including sample management, testing, and trend review.
• Review Certificates of Analysis and QC data supporting client batch disposition and support quality agreements and client audits.

Connaissances

Real-time release

QC testing

ALCOA+ data integrity

HPLC

Endotoxin testing

Sterility testing

Radiation safety

Cross-functional collab

Documentation

LIMS proficiency

Formation

Bachelor’s degree (Master’s preferred) in Chemistry, Radiochemistry, Biochemistry, Microbiology, Pharmaceutical Sciences, Nuclear Chemistry, or a related scientific field

Outils

LIMS

Excel

PowerPoint

Word

Dose calibrators

Description du poste

Eckert & Ziegler Radiopharma Inc in Wilmington, MA seeks a Senior Quality Control Specialist (Lead) to perform analytical, microbiological, and release testing for radiochemical products, ensuring rapid real-time release within short half-lives and GMP-compliant documentation.

The role collaborates with Manufacturing, QA, and capital projects, supports CMO operations, and requires a strong background in radiopharmaceutical QC, ALCOA+ data integrity, and on-site work in a regulated lab.