Senior Quality Control Specialist (Lead)
About The Position
Eckert & Ziegler Radiopharma, Inc. (EZRI) is expanding its U.S. radiopharmaceutical manufacturing and CMO operations in Wilmington, MA, including the build-out and qualification of new Lu-177 production capabilities supporting targeted cancer therapies. We are seeking a highly capable, hands-on Senior QC Specialist to support analytical testing, microbiology, method transfer, and laboratory qualification activities within a regulated cGMP environment. This is not a routine bench role. It is an opportunity to strengthen and build QC systems during a critical growth phase in one of the most dynamic sectors of modern medicine. The Senior QC Specialist reports into site Quality leadership and works closely with QA, Manufacturing, the Radiation Safety Officer, and Site Operations. This is a hands-on laboratory role with real ownership. A strong physical presence in the QC lab and engagement with manufacturing operations is expected. The position plays a key role in ensuring laboratory readiness, sterility assurance, data integrity, and timely product release. A major near-term priority is supporting Lu-177 expansion activities from a laboratory standpoint, including method transfer and qualification, equipment IQ/OQ/PQ support, environmental monitoring program strengthening, and laboratory inspection readiness. This role is ideal for a technical professional who thrives in growth environments and wants to help build and elevate QC operations — not simply execute static testing.
Requirements
- Bachelor’s degree in Chemistry, Biochemistry, Microbiology, Pharmaceutical Sciences, Nuclear Chemistry, or related scientific discipline (advanced degree preferred)
- 5–8+ years of QC experience in pharmaceutical or biotech manufacturing
- Strong hands-on analytical instrumentation experience (HPLC required)
- Experience performing microbiological testing (EM, sterility, endotoxin) in sterile environments
- Experience supporting method transfer and validation activities
- Familiarity with equipment qualification (IQ/OQ/PQ) in a cGMP setting
- Experience in cleanroom and aseptic manufacturing environments
- Working knowledge of FDA cGMP regulations (21 CFR Parts 210/211)
- Ability to work safely with low-level radioactive materials (training provided)
Nice To Haves
- Radiopharmaceutical experience preferred
Responsibilities
- Perform release and in-process analytical testing of radiopharmaceutical products (HPLC required; GC, ICP, or related systems preferred)
- Execute compendial and in-house methods in accordance with GMP standards
- Review, trend, and evaluate analytical data in alignment with ALCOA+ principles
- Support OOS, OOT, deviation investigations, and CAPA activities
- Contribute to batch record review and product disposition support
- Lead or support analytical method transfers into the QC laboratory
- Assist with method qualification, validation, and verification protocols
- Author and revise SOPs, test methods, and validation documentation
- Ensure laboratory methods meet regulatory expectations and inspection readiness standards
- Support IQ/OQ/PQ activities for QC instrumentation and laboratory equipment
- Coordinate calibration and preventive maintenance programs
- Maintain laboratory systems in an audit-ready state
- Partner cross-functionally during equipment installation and commissioning
- Execute environmental monitoring of cleanrooms, isolators, biosafety cabinets, and hot cells
- Perform viable and non-viable airborne particle monitoring
- Conduct bioburden, endotoxin, and sterility testing
- Trend environmental data and support contamination control strategy
- Support aseptic process oversight from a QC perspective
- Maintain GMP-compliant documentation and data integrity standards
- Support regulatory inspections and customer audits
- Identify and implement continuous improvement opportunities within QC operations
- Contribute to strengthening laboratory infrastructure as site operations expand
- Play a direct role in releasing life-improving radiopharmaceutical products.
Benefits
- Competitive compensation
- annual bonus eligibility
- comprehensive benefits
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What This Job Offers
Job Type
Full-time
Career Level
Senior
