Shop Floor QA Specialist - GMP Compliance & CAPA

Real Staffing Group; United States; On-site; USD 70,000 - 100,000; Full time

Job summary

Real Staffing Group is seeking a Quality Assurance Specialist to provide on-the-floor oversight for radiopharmaceutical manufacturing, testing, and material handling. You will review batch records, release GMP materials (including radioactive materials), and support product release while ensuring compliance with GMP, FDA regulations, and Health Authority requirements.

The ideal candidate has a STEM degree and 2+ years in a GMP-regulated environment, with strong documentation, investigations, and

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 documentation review, investigations, compliance management, and cross-functional problem resolution.
• Excellent communication skills with the ability to escalate quality issues and work independently in a fast-paced manufacturing environment.

Responsibilities

• Provide on-the-floor QA oversight for radiopharmaceutical manufacturing, testing, and material handling operations to ensure GMP, SOPs, GDP, FDA regulations, and Health Authority compliance.
• Review batch records, release GMP materials (including radioactive materials), and support release of radiopharmaceutical products.
• Collaborate with Manufacturing, Quality Control, and Quality Management teams to identify, investigate, and resolve compliance issues and drive continuous improvement.
• Conduct GMP walkthroughs, support investigations and CAPAs, observe media fills and aseptic processes, and ensure safe handling of radioactive materials following ALARA principles.
• Maintain quality oversight of cleanrooms, analytical laboratories, and storage areas while providing real-time coaching to operations personnel.

Skills

QA oversight

GMP compliance

Documentation review

Investigations & CAPAs

Communication

Education

B.S. in STEM

Job description

Real Staffing Group is seeking a Quality Assurance Specialist to provide on-the-floor oversight for radiopharmaceutical manufacturing, testing, and material handling. You will review batch records, release GMP materials (including radioactive materials), and support product release while ensuring compliance with GMP, FDA regulations, and Health Authority requirements.

The ideal candidate has a STEM degree and 2+ years in a GMP-regulated environment, with strong documentation, investigations, and