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Quality Assurance Specialist

1 month ago

Neshanic Station, New Jersey, United States Actalent Full time
Job Title: Quality Assurance Specialist

Job Summary:
Actalent is seeking a Quality Assurance Specialist to join our team in Branchburg, NJ. As a Quality Assurance Specialist, you will be responsible for performing visual inspections of incoming human cadaver tissue and ensuring that it meets specification requirements. You will also be responsible for data entry, cycle count, inventory management, and cross-functional communication across multiple departments.

Responsibilities:
  • Inspect and receive human and porcine tissue
  • Review batch records and ensure compliance with cGMPs, GDP, ISO, FDA, and USP regulations
  • Perform cycle count and inventory management tasks
  • Communicate with cross-functional teams to resolve issues and nonconformances
  • Assist in documentation updates and change control activities

Requirements:
  • 5+ years of experience in a cGMPs, GDP, ISO, FDA regulated industry
  • Advanced computer skills with high knowledge and understanding of Windows-based computer systems
  • cGMPs, AATB Standards, ISO, FDA, and USP regulatory guidelines
  • SAP (ERP) knowledge
  • Basic knowledge of statistical techniques and quality tools

Work Environment:
This is a fully on-site position in Branchburg, New Jersey. The work environment is cGMPs, GDP, ISO, FDA regulated USP environment.