Senior Quality Control Specialist

Eckert & Ziegler Radiopharma Inc•Wilmington, MA

4d•$90,000 - $110,000•Onsite

About The Position

The Senior Quality Control Specialist performs analytical, microbiological, and release testing under approved procedures to support timely, compliant release of radiochemical and radiopharmaceutical products across GMP and non-GMP operations and internal contract manufacturing programs. Because products have short radioactive half-lives, the role conducts rapid, real-time release testing so product disposition occurs within usable shelf life. The Specialist supports laboratory readiness through equipment qualification, calibration, and maintenance, and maintains accurate, complete, contemporaneous QC records under a phase-appropriate framework. Under the direction of the Quality Control Manager, the role helps preserve a clear boundary between GMP drug-product testing and non-GMP isotope activities and supports Manufacturing, Quality Assurance, internal CMO programs, capital and expansion projects, and continuous improvement initiatives. This is an on-site role in Wilmington, Massachusetts. It requires schedule flexibility beyond standard weekday hours, including early mornings, evenings, weekends, and holidays, to support time-critical testing and production and shipment schedules. Work takes place in and around GMP manufacturing, laboratory, radioactive-materials, classified, and aseptic areas. The role requires handling radioactive materials, appropriate PPE and radiation dosimetry, and compliance with radiation-safety and ALARA requirements. Physical demands include remaining seated or standing for extended periods, climbing stairs, and lifting up to 25 pounds. There are no direct supervisory responsibilities, though the Specialist may train and mentor junior analysts and technicians.

Requirements

Bachelor’s degree 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 supporting CMO or contract manufacturing operations, technology transfer, and quality agreements.
Working knowledge of deviations, OOS/OOT investigations, CAPA, change control, and ALCOA+ data integrity.
Familiarity with radioactive-material handling and applicable radiation-safety requirements, such as 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.
Ability to remain seated or standing for extended periods, climb stairs, and lift up to 25 pounds.
Must use appropriate PPE and radiation dosimetry and comply with radiation-safety and ALARA requirements.

Nice To Haves

Master’s degree in a listed or related scientific field is preferred.
Experience with short-half-life products and rapid or real-time release testing is strongly preferred.
Experience supporting capital projects, commissioning and qualification (C&Q), and new equipment or facility start-up is preferred.

Responsibilities

Perform QC release testing of radiochemical and radiopharmaceutical products, including rapid and real-time testing within half-life-constrained release windows.
Follow testing sequences, retain-sample handling procedures, and decay-corrected reporting requirements; review analytical data and Certificates of Analysis and support QA in final product release.
Coordinate testing schedules with Manufacturing to meet time-critical calibration, dispensing, production, and shipment windows.
Perform environmental monitoring of GMP classified and aseptic areas, including viable and non-viable, personnel, and surface monitoring; track and trend results and support excursion investigations and corrective actions.
Perform and support IQ/OQ/PQ and requalification of QC and manufacturing equipment, and calibrate and maintain analytical instruments including balances, pipettes, HPLC, GC, ICP, and dose calibrators.
Track incoming raw materials and components through receipt, sampling, testing, and disposition; perform identity and quality testing and apply quarantine, released, or rejected status controls and labeling.
Provide routine QC support to Manufacturing, including in-process testing, sampling, bioburden, endotoxin, and sterility testing as appropriate for short-half-life products.
Partner with Manufacturing, Supply Chain, and QA on batch record review, in-process and release limits, and material investigations.
Support internal CMO manufacturing operations and GMP testing for client and sponsor programs.
Support technology and method transfer, including transfer of analytical methods, specifications, and processes, as well as associated qualification and comparability.
Assist with phase-appropriate qualification and validation of radiopharmaceutical test methods and support stability sample management, testing, and trend review.
Support capital and facility expansion projects, including QC input to user requirements, commissioning and qualification, and equipment and area qualification such as FAT/SAT and IQ/OQ/PQ.
Review Certificates of Analysis and QC data for client batch disposition and support quality agreements and client audits.
Support QC deviations, OOS/OOT investigations, CAPA, and change controls, including root-cause analysis and timely, science-based resolution.
Maintain complete, accurate, contemporaneous records and apply ALCOA+ data-integrity principles to manual and instrument-generated QC data.
Maintain procedural and physical segregation between GMP and non-GMP isotope testing, materials, and records.
Author and revise QC SOPs, specifications, and test methods appropriate to clinical phase, and maintain good documentation practices.
Support regulatory inspections and client and internal audits with QC documentation and subject-matter expertise; perform other duties as assigned by the QC Manager.
May train and mentor junior QC analysts and technicians and support coverage for time-critical release testing, including evenings, weekends, and holidays.