Quality Assurance Analyst II

Roles & Responsibilities

• Support the qualification, onboarding, and ongoing oversight of a new 3PL partner to ensure compliance with applicable GxP, FDA, and ISO requirements
• Partner closely with Fulfillment, Supply Chain, and Operations teams to establish compliant distribution and warehousing processes
• Review, approve, and help implement quality agreements, SOPs, and work instructions related to 3PL activities
• Conduct and support vendor qualification activities, including risk assessments and audits (on site or remote)
• Ensure proper handling of temperature controlled, regulated, and serialized products, as applicable
• Support deviation investigations, CAPAs, and change controls associated with 3PL operations
• Auxiliary in setting up and maintaining documentation, records, and training requirements for the 3PL partner
• Maintain monitoring of 3PL performance through metrics, quality KPIs, and periodic reviews
• Serve as a quality liaison between the company and the 3PL to drive continuous improvement and compliance

Education & Experience

• Bachelor's degree in Quality, Life Sciences, Engineering, or a related field
• Experience in a regulated environment (medical device, pharmaceutical, or biotech)
• Working knowledge of GxP, FDA regulations, and quality systems related to distribution and logistics
• Experience supporting or interacting with third party vendors or 3PL partners preferred
• Strong documentation, communication, and cross functional collaboration skills