QA Specialist- Shop Floor

Real Staffing; United States; Vor Ort; USD 70.000 - 100.000; Vollzeit

Zusammenfassung

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

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

QA oversight

GMP compliance

Documentation review

Investigations & CAPAs

Communication

Ausbildung

B.S. in STEM

Jobbeschreibung

(Quality Assurance Specialist / Shop Floor QA)

• Provides on-the-floor Quality Assurance oversight for radiopharmaceutical manufacturing, testing, and material handling operations to ensure compliance with GMP, SOPs, GDP, FDA regulations, and Health Authority requirements.
• Reviews manufacturing and quality documentation, performs batch record review, releases GMP materials (including radioactive materials), and supports the release of radiopharmaceutical products.
• Partners closely with Manufacturing, Quality Control, and Quality Management teams to proactively identify, investigate, and resolve compliance issues, reducing non-conformances and driving continuous improvement.
• Conducts GMP walkthroughs, supports investigations and CAPAs, observes media fills and aseptic processes, performs microbiological support activities, and ensures safe handling of radioactive materials following ALARA principles.
• Maintains quality oversight of cleanroom manufacturing, analytical laboratories, and material storage areas while providing real-time coaching and compliance guidance to operations personnel.

Key Qualifications

• Bachelor's degree in a STEM field.
• 2+ years of experience 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 escalate quality issues and work independently in a fast-paced manufacturing environment.

Ideal Candidate Profile

A QA professional with experience supporting GMP manufacturing operations, conducting shop floor quality oversight, reviewing regulated documentation, supporting investigations/CAPAs, and ensuring compliance in pharmaceutical or radiopharmaceutical production environments. Experience with aseptic processing, cleanrooms, microbiology practices, and radioactive material handling is highly desirable.

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

In addition to base pay, employees may be eligible for benefits such as health insurance, health savings accounts, retirement savings plans, life and disability insurance, and paid leave where required by applicable law. Eligibility may vary based on factors such as location and hire date and is subject to change.