Quality Assurance Analyst II

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:
Bachelors 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