Quality Assurance Specialist I

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.
• Absorb and release product as necessary.
• Perform record reviews to ensure compliance with all applicable procedures and regulations.
• Take part on ISM (Inventory System Management) after hours rotation program.
• Absorb and release product as necessary.
• Absorb and release product as necessary.
• Absorb and release product as necessary.
• Absorb and release product as necessary.
• Absorb and release product as necessary.
• Absorb and release product as necessary.
• Absorb and release product as necessary.
• Absorb and release product as necessary.
• Absorb and release product as necessary.
• Absorb and release product as necessary.
• Absorb and release product as necessary.
• Absorb and release product as necessary.
• Absorb and release product as necessary.
• Absorb and release product as necessary.
• Absorb and release product as necessary.
• Absorb and release product as necessary.
• Absorb and release product as necessary.
• Absorb and release product as necessary.
• Absorb and release product as necessary.
• Absorb and release product as necessary.
• Absorb and release product as necessary.
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• Absorb and release product as necessary.
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