Eckert & Ziegler Radiopharma Inc
Senior Quality Control Specialist (Lead)
Eckert & Ziegler Radiopharma Inc, Wilmington, Massachusetts, United States, 01887
Job Description
Job Description
???? Now Hiring: Senior Quality Control Specialist (Lead)???? ???? Wilmington, MA | ????
Radiopharmaceutical
Manufacturing | ???? Full-Time, Onsite About Us ???????? Eckert & Ziegler Radiopharma, Inc. (EZRI) is a
U.S.-based, wholly owned subsidiary of Eckert & Ziegler AG , operating a
clinical-stage
radiopharmaceutical
contract manufacturing facility
in Wilmington, Massachusetts. With fewer than 50 employees, we are a
small, agile U.S. entity
with global backing, dedicated to advancing nuclear medicine. Our focus is on
Yttrium-90 (Y-90) production, Lutetium-177 (Lu-177) expansion, and contract manufacturing services (CMO/CDMO)
for radiolabeling pharmaceuticals. As part of a global leader in isotope technology, EZRI combines
world-class standards
with the agility of a
tight-knit U.S. team . ✨ Position Summary The
Senior QC Specialist
plays a critical role in ensuring the timely release of
high-quality
radiopharmaceutical
products . This position performs
analytical and microbiological testing , maintains laboratory readiness, supports equipment qualification, and ensures compliance with our
Quality Management System (QMS)
and all
GMP regulations . ???? Key Responsibilities
???? Perform QC testing and inspection of finished products.
???? Inspect incoming materials and qualify through approved procedures.
⚙️ Operate, calibrate, and maintain analytical instruments (HPLC, GC, ICP, etc.).
???? Execute microbiology testing: Environmental monitoring of cleanrooms, biosafety cabinets, isolators, and hot cells.
Viable & non-viable airborne particle monitoring.
Bioburden, endotoxin, and sterility testing.
???? Author and revise SOPs, protocols, and test methods.
????️ Support investigations, CAPAs, deviations, and non-conformance reporting.
???? Maintain GMP-compliant, data integrity–aligned records (ALCOA+).
???? Assist in analytical method development, transfer, and validation.
???? Identify and recommend process improvements.
???? Supervisory Responsibilities
No direct supervisory responsibilities.
May provide
training and mentorship
to junior QC staff.
???? Required Skills & Qualifications
???? B.S. (M.S. preferred) in Chemistry, Biochemistry, Microbiology, Pharmacy, Nuclear Chemistry, or related field.
???? 5–8 years QC experience in pharmaceutical manufacturing (radiopharma experience
highly preferred ).
???? Strong expertise with analytical instrumentation (HPLC, GC, ICP).
???? Knowledge of microbiology methods & equipment (particle counters, endotoxin systems, sterility systems).
???? Experience in cleanrooms, isolators, and aseptic GMP environments.
???? Familiarity with data trending and statistical QC analysis.
???? Experience with electronic QMS/documentation systems (preferred).
????️ Proficiency in Microsoft Office Suite.
✍️ Excellent organizational, written, and verbal communication skills.
☢️ Ability to work safely with low-level radioactive materials (training provided).
???? Highly collaborative and team-oriented.
???? Work Schedule & Conditions
???? Onsite during regular business hours.
⏰ Occasional weekends, holidays, or off-hours to support manufacturing.
???? Ability to stand for extended periods and lift up to 25 lbs.
???? Must gown and work in aseptic cleanroom environments.
Why Join Us? ???? At EZRI, you’ll have the opportunity to: Be part of a
small but impactful U.S. team
shaping the future of radiopharma.
Gain hands-on exposure to both
analytical and microbiological QC
in a GMP-regulated environment.
Contribute to the
advancement of nuclear medicine
that improves patients’ lives worldwide.
???? Ready to advance your career in radiopharma QC? Apply today and grow with us at EZRI!
Job Description
???? Now Hiring: Senior Quality Control Specialist (Lead)???? ???? Wilmington, MA | ????
Radiopharmaceutical
Manufacturing | ???? Full-Time, Onsite About Us ???????? Eckert & Ziegler Radiopharma, Inc. (EZRI) is a
U.S.-based, wholly owned subsidiary of Eckert & Ziegler AG , operating a
clinical-stage
radiopharmaceutical
contract manufacturing facility
in Wilmington, Massachusetts. With fewer than 50 employees, we are a
small, agile U.S. entity
with global backing, dedicated to advancing nuclear medicine. Our focus is on
Yttrium-90 (Y-90) production, Lutetium-177 (Lu-177) expansion, and contract manufacturing services (CMO/CDMO)
for radiolabeling pharmaceuticals. As part of a global leader in isotope technology, EZRI combines
world-class standards
with the agility of a
tight-knit U.S. team . ✨ Position Summary The
Senior QC Specialist
plays a critical role in ensuring the timely release of
high-quality
radiopharmaceutical
products . This position performs
analytical and microbiological testing , maintains laboratory readiness, supports equipment qualification, and ensures compliance with our
Quality Management System (QMS)
and all
GMP regulations . ???? Key Responsibilities
???? Perform QC testing and inspection of finished products.
???? Inspect incoming materials and qualify through approved procedures.
⚙️ Operate, calibrate, and maintain analytical instruments (HPLC, GC, ICP, etc.).
???? Execute microbiology testing: Environmental monitoring of cleanrooms, biosafety cabinets, isolators, and hot cells.
Viable & non-viable airborne particle monitoring.
Bioburden, endotoxin, and sterility testing.
???? Author and revise SOPs, protocols, and test methods.
????️ Support investigations, CAPAs, deviations, and non-conformance reporting.
???? Maintain GMP-compliant, data integrity–aligned records (ALCOA+).
???? Assist in analytical method development, transfer, and validation.
???? Identify and recommend process improvements.
???? Supervisory Responsibilities
No direct supervisory responsibilities.
May provide
training and mentorship
to junior QC staff.
???? Required Skills & Qualifications
???? B.S. (M.S. preferred) in Chemistry, Biochemistry, Microbiology, Pharmacy, Nuclear Chemistry, or related field.
???? 5–8 years QC experience in pharmaceutical manufacturing (radiopharma experience
highly preferred ).
???? Strong expertise with analytical instrumentation (HPLC, GC, ICP).
???? Knowledge of microbiology methods & equipment (particle counters, endotoxin systems, sterility systems).
???? Experience in cleanrooms, isolators, and aseptic GMP environments.
???? Familiarity with data trending and statistical QC analysis.
???? Experience with electronic QMS/documentation systems (preferred).
????️ Proficiency in Microsoft Office Suite.
✍️ Excellent organizational, written, and verbal communication skills.
☢️ Ability to work safely with low-level radioactive materials (training provided).
???? Highly collaborative and team-oriented.
???? Work Schedule & Conditions
???? Onsite during regular business hours.
⏰ Occasional weekends, holidays, or off-hours to support manufacturing.
???? Ability to stand for extended periods and lift up to 25 lbs.
???? Must gown and work in aseptic cleanroom environments.
Why Join Us? ???? At EZRI, you’ll have the opportunity to: Be part of a
small but impactful U.S. team
shaping the future of radiopharma.
Gain hands-on exposure to both
analytical and microbiological QC
in a GMP-regulated environment.
Contribute to the
advancement of nuclear medicine
that improves patients’ lives worldwide.
???? Ready to advance your career in radiopharma QC? Apply today and grow with us at EZRI!