The Quality Associate supports the setup and qualification of a new third party logistics (3PL) partner, ensuring distribution activities comply with GxP, FDA, and quality system requirements for medical device and pharmaceutical products. This role partners closely with Fulfillment, Supply Chain, and Manufacyturing teams to establish compliant processes, documentation, and oversight for regulated product distribution.
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
Assist with setting up and maintaining documentation, records, and training requirements for the 3PL partner
Monitor 3PL performance through metrics, quality KPIs, and periodic reviews
Support regulatory inspections and internal audits involving distribution and logistics processes
Serve as a quality liaison between the company and the 3PL to drive continuous improvement and compliance
Qualifications:
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
Position is Hybrid from Indy. Manager will consider candidates from Deerfield or Memphis GLC in Byhalia
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