Quality Assurance Analyst II (Hybrid)
Indianapolis, IN (Hybrid)
About the Role
Baxter is seeking a Quality Associate to support the qualification and onboarding of a new third?party logistics (3PL) partner. This role plays a critical part in ensuring distribution and warehousing activities comply with GxP, FDA, ISO, and internal quality system requirements for medical device and pharmaceutical products.
This position partners closely with Fulfillment, Supply Chain, Manufacturing, and Operations teams to establish compliant processes, documentation, and ongoing oversight in a regulated distribution environment.
Key Responsibilities
- Support the qualification, onboarding, and oversight of a new 3PL partner to ensure compliance with applicable GxP, FDA, and ISO requirements.
- Partner cross?functionally with Fulfillment, Supply Chain, Manufacturing, and Operations teams to establish compliant distribution and warehousing processes.
- Review, approve, and assist with implementing quality agreements, SOPs, and work instructions related to 3PL activities.
- Conduct and support vendor qualification activities, including risk assessments and on-site or remote audits.
- 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 establishing and maintaining documentation, records, and training requirements for the 3PL partner.
- Monitor 3PL performance using quality KPIs, metrics, and periodic reviews.
- Support regulatory inspections and internal audits related to distribution and logistics processes.
- Serve as a quality liaison between Baxter and the 3PL partner to drive continuous improvement and compliance.
Qualifications
- Bachelor’s degree in Quality, Life Sciences, Engineering, or a related field.
- Experience working in a regulated environment such as medical device, pharmaceutical, or biotech.
- Working knowledge of GxP, FDA regulations, and quality systems related to distribution and logistics.
- Experience supporting or working with third-party vendors or 3PL partners preferred.
- Strong documentation, communication, and cross?functional collaboration skills.
Additional Details
- Work Arrangement: Hybrid
- Pay Rate: $60-62/hour
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