Quality Assurance Analyst II

Quality AssociateThe 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 Manufacturing teams to establish compliant processes, documentation, and oversight for regulated product distribution.Roles and responsibilities include:Support the qualification, onboarding, and ongoing oversight of a new 3PL partner to ensure compliance with applicable GxP, FDA, and ISO requirementsPartner closely with Fulfillment, Supply Chain, and Operations teams to establish compliant distribution and warehousing processesReview, approve, and help implement quality agreements, SOPs, and work instructions related to 3PL activitiesConduct 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 applicableSupport deviation investigations, CAPAs, and change controls associated with 3PL operationsAssist with setting up and maintaining documentation, records, and training requirements for the 3PL partnerMonitor 3PL performance through metrics, quality KPIs, and periodic reviewsSupport regulatory inspections and internal audits involving distribution and logistics processesServe as a quality liaison between the company and the 3PL to drive continuous improvement and complianceEducation and experience required:Bachelor's degree in Quality, Life Sciences, Engineering, or a related fieldExperience in a regulated environment (medical device, pharmaceutical, or biotech)Working knowledge of GxP, FDA regulations, and quality systems related to distribution and logisticsExperience supporting or interacting with third party vendors or 3PL partners preferredStrong documentation, communication, and cross functional collaboration skills