GMP Radiopharma QA Specialist – Floor Compliance & CAPA

Real; Springfield (NJ); On-site; USD 70,000 - 95,000; Full time

Benefits offered by this job

Health insurance

Retirement plan

Paid leave

Job summary

Real is seeking a Quality Assurance Specialist to provide on-the-floor QA oversight for radiopharmaceutical manufacturing, testing, and material handling in a GMP-regulated environment on-site in New Jersey.

The role involves reviewing batch records, releasing GMP materials (including radioactive materials), and collaborating with Manufacturing, QC, and Quality Management to resolve issues and drive continuous improvement.

Qualifications

• Bachelor's degree in a STEM field.
• 2+ years in a GMP-regulated pharmaceutical, biotech, or radiopharmaceutical environment.
• Knowledge of pharmaceutical manufacturing, analytical laboratory operations, aseptic processing, and FDA regulations.
• Strong skills in documentation review, investigations, compliance management, and cross-functional problem resolution.
• Excellent communication skills with the ability to elevate quality issues and work independently in a fast-paced manufacturing environment.

Responsibilities

• On-the-floor QA oversight of radiopharmaceutical manufacturing.
• Review batch records and release GMP materials (including radioactive materials).
• Support release of radiopharmaceutical products.
• Collaborate with Manufacturing, Quality Control, and Quality Management to identify, investigate, and resolve compliance issues.
• Conduct GMP walkthroughs, support investigations and CAPAs, observe aseptic processes, and ensure safe handling of radioactive materials per ALARA.

Skills

GMP compliance

Documentation review

Investigations

CAPA

Cross-functional collaboration

Communication skills

Education

Bachelor's degree in a STEM field

Job description

Real is seeking a Quality Assurance Specialist to provide on-the-floor QA oversight for radiopharmaceutical manufacturing, testing, and material handling in a GMP-regulated environment on-site in New Jersey.

The role involves reviewing batch records, releasing GMP materials (including radioactive materials), and collaborating with Manufacturing, QC, and Quality Management to resolve issues and drive continuous improvement.