Senior Quality Control Specialist

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Production Wilmington, MA, US

Salary Range: $90,000.00 To $ Annually

Job Title:

Senior Quality Control Specialist (Lead)

Department:

Quality

Reports To:

Quality Control Manager

The Senior Quality Control (QC) Specialist performs analytical, microbiological, and release testing in accordance with approved procedures to support the timely, compliant release of radio chemical 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.

1. QC Testing & Product Release

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

• Perform QC release testing of radio chemical 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,…