Quality Assurance Analyst

Job Title: Quality Assurance Analyst II

Duration: 12 Months

Shift 1st Shift

Location: Indianapolis, IN 46268

Pay Rate: $61.30/Hour on W2

Job Description:

• 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 Manufacturing 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.