Senior Quality Control Specialist

Eckert & Ziegler Radiopharma Inc; Wilmington (MA); Vor Ort; USD 90.000 - 110.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Real-time release

QC testing

ALCOA+ data integrity

HPLC

Endotoxin testing

Sterility testing

Radiation safety

Cross-functional collab

Documentation

LIMS proficiency

Ausbildung

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

Tools

LIMS

Excel

PowerPoint

Word

Dose calibrators

Jobbeschreibung

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Senior Quality Control Specialist

Production Wilmington, MA, US

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

Job Title:

Senior Quality Control Specialist (Lead)

Department:

Quality

Reports To:

Quality Control Manager

Position Summary

The Senior Quality Control (QC) Specialist performs analytical, microbiological, and release testing in accordance with approved procedures to support the timely, compliant release of radiochemical and radiopharmaceutical products manufactured at Eckert & Ziegler Radiopharma, Inc. (EZRI) in Wilmington, Massachusetts, across GMP and non-GMP operations and the site’s internal contract manufacturing (CMO) programs. Given the short radioactive half-lives of these products, the Specialist executes rapid, real-time release testing so that product disposition occurs within the usable shelf life. The Specialist ensures laboratory readiness through equipment qualification, calibration, and maintenance support, and maintains the accuracy, integrity, and contemporaneous documentation of QC data under a phase-appropriate framework. Working under the direction of the QC Manager, the Sr QC Specialist helps maintain a clear, defensible boundary between GMP drug-product testing and non-GMP isotope activities and supports Manufacturing, Quality Assurance, capital and expansion projects, and continuous improvement initiatives.

Key Responsibilities

1. QC Testing & Product Release

Scope: In-process, release, and stability-related testing of radiochemical and radiopharmaceutical products, including rapid and real-time release to accommodate short radioactive half-lives.

• 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.

Scope: Environmental monitoring of GMP areas and QC oversight of equipment qualification and calibration for laboratory and manufacturing equipment.

• 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.

3. Incoming Raw Materials & In-Process QC Support

Scope: Receipt, testing, release, and labeling of incoming raw materials, and routine QC support of GMP manufacturing.

• 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.

4. Internal CMO Operations, Technology Transfer, Method Qualification & Capital Projects

Scope: QC support of the site’s internal CMO manufacturing operations, technology and method transfer, analytical method qualification, stability programs, and capital and facility expansion projects.

• 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.

5. QC Compliance, Data Integrity & Investigations

Scope: GMP compliance, data integrity, investigation management, and clear separation between GMP drug product and non-GMP isotope activities.

• Support QC deviations, OOS/OOT investigations, CAPA, and change controls, including root cause analysis and timely, science-based resolution.
• Maintain complete, accurate, and contemporaneous records and apply ALCOA+ data-integrity principles across manual and instrument-generated QC data.
• Maintain clear 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 and perform other duties as assigned by the QC Manager.

Key Performance Expectations

• Release testing of radiochemical and radiopharmaceuticalproducts completed accurately and within half-life-constrained release windows.
• Routine QC support delivered to Manufacturing without disruption to production and shipment schedules.
• Internal CMO operations and technology transfers supported with accurate, inspection-ready, client-facing data.
• Capital and facility expansion projects supported with timely, inspection-ready QC qualification and method-readiness deliverables.
• Environmental monitoring, microbiological, and stability testing completed on schedule and laboratory readiness maintained.
• Deviations, OOS/OOT investigations, and CAPAs supported and documented on time with science-based rationale.
• Phase-appropriate GMP, data integrity, and the GMP/non-GMP isotope boundary maintained with minimal findings.

Supervisory Responsibilities

• No direct supervisory responsibilities. May provide training and mentoring to junior QC analysts and technicians. Supports adequate coverage for time-critical release testing driven by short radioactive half-lives, including evenings, weekends, and holidays as needed.

Required Skills & 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.

Work Schedule & Conditions

• On-site role based in Wilmington, Massachusetts.
• Requires flexibility beyond standard weekday hours - including early mornings, evenings, weekends, and holidays - to support time-critical release testing driven by short radioactive half-lives and by production and shipment schedules.
• Work in and around GMP manufacturing, laboratory, and radioactive-materials areas, including classified and aseptic environments.
• Requires handling of radioactive materials and use of appropriate personal protective equipment (PPE) and radiation dosimetry; must comply with radiation safety and ALARA requirements.
• Must be able to remain standing or seated for extended periods, climb stairs to access office areas and lift up to 25 lbs.