QA Analyst II – 3PL Compliance & Distribution

Katalyst CRO; Indianapolis (IN); On-site; USD 50,000 - 70,000; Full time

Job summary

Katalyst CRO in Indianapolis is seeking a Quality Associate to support the setup and qualification of a new third-party logistics partner. This role involves ensuring distribution activities comply with GxP, FDA, and quality system requirements for medical devices. Responsibilities include vendor qualification, compliance monitoring, and serving as a liaison between the company and the 3PL partner. A bachelor's degree in Quality or related fields along with experience in regulated environments is required.

Qualifications

• 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.

Responsibilities

• Support the qualification, onboarding, and oversight of a new 3PL partner.
• Establish compliant distribution and warehousing processes.
• Review and implement quality agreements, SOPs, and work instructions.
• Conduct vendor qualification activities, including risk assessments and audits.
• Support deviation investigations, CAPAs, and change controls.

Skills

Documentation skills

Communication skills

Cross-functional collaboration

Education

Bachelor's degree in Quality, Life Sciences, Engineering, or a related field

Job description

Katalyst CRO in Indianapolis is seeking a Quality Associate to support the setup and qualification of a new third-party logistics partner. This role involves ensuring distribution activities comply with GxP, FDA, and quality system requirements for medical devices. Responsibilities include vendor qualification, compliance monitoring, and serving as a liaison between the company and the 3PL partner. A bachelor's degree in Quality or related fields along with experience in regulated environments is required.