Quality Assurance Specialist I

Job Description

Job Description

Responsibilities

• Provide support during regulatory FDA, DEA, State inspections and customer audits.
• Plan and present Quality System information to internal and external groups
• Initiate, review, and approve Change Controls, Recalls, Deviation for nonconformances, & Reactive Maintenance
• Work to maintain Quality Systems policies and procedures to ensure regulatory compliance
• Be a part of the internal audit team and assist in external audits
• Release “quarantined” product upon receipt of documentation from Client and use Hold and Release process, take part in Recall
• Review / approve product-specific paperwork particular to Client guidelines, Deviations and CAPAs
• Assist in Operations and Facilities team in determining root cause of discrepancies and help develop corrective actions and verification activities
• Revise SOPs and WIs for process enhancement
• Perform Gemba walk applies six sigma concepts such as 5S’s
• Participate in cross-functional initiatives for a 3PL environment
• Strong leadership skills and logistics (3PL) knowledge
• Able to professionally communicate with customers / clients
• Assist in returns and damages process
• Perform record reviews to ensure compliance with all applicable procedures and regulations
• Take part on ISM (Inventory System Management) after hours rotation program
• Assist in validation projects
• Being able to be on call for WebCTRL temperature monitoring on a rotation program
• Assist in generating and reviewing temperature monthly reports in a timely manner
• Other duties as assigned

Qualifications and Job Specifications

Technical Expertise

Additional Employment Requirements

Physical / Mental / Visual Demands

Working Conditions

Equipment Operated