QA Investigator II

Quality Assurance Investigator

Location: Lenoir, NC
Employment Type: Full-Time, On-Site
Salary Range: $65,000-$80,000/year

Position Summary

A growing pharmaceutical manufacturing organization is seeking a Quality Assurance Investigator to support its quality systems and compliance efforts. This role is responsible for investigating quality events, supporting audits and inspections, and collaborating across departments to ensure continuous improvement in a regulated environment.

Key Responsibilities

• Conduct and document investigations related to:
  • Deviations
  • Complaints
  • Discrepant Material Reports
  • Laboratory Out-of-Limits results
  • Building Monitoring System alerts
  • Calibration Out-of-Tolerance events
  • Product Out-of-Yield occurrences
  • CAPA reports
  • Critical System Work Orders
• Review and support:
  • Change Notifications and Requests
  • Document revisions and protocol development
  • Compilation and analysis of quality metrics
• Participate in internal and external audits (travel may be required)
• Support regulatory inspections and media fills
• Communicate quality issues to management and cross-functional teams
• Assist in the creation of business documents and procedures
• Ensure alignment with applicable governmental regulations

Qualifications

• Bachelor's degree in a scientific field required
• 2-5 years of experience in pharmaceutical manufacturing or equivalent post-secondary education
• Strong technical writing and critical thinking skills
• Detail-oriented with the ability to work independently and collaboratively
• Familiarity with GMP and regulatory compliance standards

Physical & Technical Requirements

• Must qualify for Type 4 Garb (Sterile Containment Suit, Hood, Face Mask, Gloves, Boots, Goggles)
• Ability to sit, talk, hear, and adjust visual focus
• Must pass a visual acuity test
• Basic computer proficiency in word processing, databases, and inventory systems (e.g., Edwards or equivalent)