Quality Assurance Associate, On the Floor

Role Summary

Your Role: Quality Assurance Associate, On the Floor

The Quality Associate provides daily assistance and guidance to issues such as non-conformance investigations, change controls, procedure/manufacturing batch record changes, validations, batch disposition, and qualification activities. The QA Associate works as a team member within the operations teams to achieve site goals while maintaining a strong quality mindset.

Responsibilities

• Provide direct oversight and guidance in operational areas to ensure robust quality systems, compliance with GMP and EGQS, and readiness for internal/external regulatory inspections.
• Assist with batch disposition for incoming, semi-finished, and finished materials, and effectively review/approve controlled documents including non-conformances, procedures, and validation protocols.
• Lead and collaborate with cross-functional teams to investigate deviations, assess non-conformances, reduce compliance risks, and define/ensure effectiveness of Root Cause Investigations (RCI) and CAPAs.
• Lead, mentor, and coach operations and support personnel on quality matters, and provide guidance for Lean, Six-Sigma, and Operational Excellence initiatives.
• Serve on project teams to provide Quality and compliance input and assist with day-to-day Quality operational activities and material handling.

Qualifications

• Required: B.S. Degree or equivalent in Microbiology/Biology/Chemistry/Engineering or related field.
• Required: Root cause analysis and troubleshooting skills.
• Required: Demonstrate strong oral, written, and interpersonal skills.
• Preferred: M.S degree highly desirable.
• Preferred: Experience working in an FDA or USDA regulated industry.
• Preferred: Knowledge of or experience in Lean, Six-Sigma or Operational Excellence.
• Preferred: Experience in Quality Systems – preferably in the pharmaceutical or a healthcare related industry.

Education

• B.S. Degree or equivalent in Microbiology/Biology/Chemistry/Engineering or related field
• M.S degree (preferred)

Additional Requirements

• Must not have contact with avian species (birds) at home due to the nature of the manufacturing.