QA Specialist- Shop Floor

Real; Springfield (NJ); Vor Ort; USD 70.000 - 95.000; Vollzeit

Benefits dieser Stelle

Health insurance

Retirement plan

Paid leave

Zusammenfassung

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.

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 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.

Aufgaben

• 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.

Kenntnisse

GMP compliance

Documentation review

Investigations

CAPA

Cross-functional collaboration

Communication skills

Ausbildung

Bachelor's degree in a STEM field

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 elevate 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.

To find out more about Real, please visit www.realstaffing.com