Nuclear Pharmacist I — Radiopharmaceutical QA & Compliance

SOFIE; Haverhill (MA); On-site; USD 130,000 - 140,000; Full time

Job summary

SOFIE is seeking a Nuclear Pharmacist I to compound and dispense radiopharmaceuticals in a cleanroom environment, with exposure to radiation. The role supports the Quality Assurance Program and collaborates with QA at the site level, ensuring compliance with USP and FDA regulations and maintaining cGMP standards.

The position involves data entry, dose management, and coordination with QA for investigations, CAPAs, deviations, and batch release.

Qualifications

• Requires degree and pharmacy license; nuclear certification preferred.
• State license required (to be obtained post-hire if applicable).
• Background in nuclear pharmacy, PET, radiation safety, and/or familiarity with cyclotron processes preferred.
• Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations required.
• Ability to write reports, business correspondence, and procedure manuals required.
• Ability to effectively present information and respond to questions or complaints from groups of managers, clients, customers, the public or regulatory agencies required.
• Ability to define problems, collect data, establish facts, and draw valid conclusions required.
• Strong management and interpersonal skills required.
• Proficient in MS Office; Pinestar or other pharmacy applications preferred.
• Detail-oriented, dependable, patient, organized, and team-oriented.
• Ability to work various shifts and weekends; up to 10% travel.

Responsibilities

• Perform compounding, dispensing, and distribution of radiopharmaceuticals, including data entry with Pinestar for reports.
• Synthesize, quality control, and quality assurance of FDG and NaF, including reagent preparation.
• Ensure compliance with USP regulations and 21 CFR Parts 211 and 212; maintain cGMP in the site QA program.
• Adhere to SOPs and regulations; maintain radiation and laboratory safety at the site.
• Monitor metrology program; ensure equipment is maintained, calibrated, and validated.
• Review and release batch records with QA; open change controls and maintain procedures.
• Oversee radiopharmaceutical manufacturing QC activities and resolve quality issues on the floor.
• Provide quality customer service to physicians, healthcare workers, and customers as needed.
• Train and supervise nuclear pharmacy technicians; maintain training records.
• Attend corporate and site meetings; perform other duties as assigned.

Skills

Nuclear pharmacy knowledge

Quality Assurance

cGMP compliance

Regulatory understanding

Attention to detail

Communication skills

Teamwork

Leadership

Documentation

Problem solving

Education

Bachelor of Science or Pharm.D.

Nuclear certification (preferred)

Tools

Pinestar

MS Office

Job description

SOFIE is seeking a Nuclear Pharmacist I to compound and dispense radiopharmaceuticals in a cleanroom environment, with exposure to radiation. The role supports the Quality Assurance Program and collaborates with QA at the site level, ensuring compliance with USP and FDA regulations and maintaining cGMP standards.

The position involves data entry, dose management, and coordination with QA for investigations, CAPAs, deviations, and batch release.