Quality Assurance Analyst/Assistant

Background

• Works under general supervision of the Quality Assurance Manager in a cGMP regulated manufacturing environment operating under ICH Q7A standards.
• Employees in positions at this level perform tasks and duties associated with implementation of and compliance to quality assurance standards set by the organization and its customers.

Tasks

• Coordinate customer complaint investigations, tracking investigation status and providing verbal and/or written updates to QA, Production, and Sales management teams.
• Perform inspection of customer-returned goods, documenting findings and performing disposition labeling. 
• Provide quality systems and regulatory information to customers as requested. 
• Conduct monthly housekeeping /sanitation/biodefense inspections and track associated action items to completion. 
• Review pest control reports and track associated corrective actions.
• Assist with information and document gathering during customer and regulatory audits.
• Perform and document mock product and raw material recalls.
• Assist with visual inspection of outgoing product shipments as needed.
• Maintain and enhance site safety.
• Other duties as assigned.

Specifications

• H.S. diploma   
• One  (1) year of experience in manufacturing or quality assurance in a cGMP manufacturing environment
• Knowledge of:
  • cGMP regulations (Basic level)
  • Basic Mathematics
  • MS Office software package (Broad level)
  • Skill in:
    • Data Processing with attention to detail and documentation
    • Working effectively and efficiently on multiple projects at once
    • Working effectively in a team environment
    • Responding to rapidly changing demands
    • Ability to:
      • Communicate effectively, orally and in writing
      • Review, compile and verify technical data and documents
      • Identify, gather, process and record data accurately
      • Follow customer, organizational and regulatory standards

FLSA

• Non-Exempt

Current Openings for Quality Assurance Analyst/Assistant Jobs at Jost Chemical Co.