Quality Assurance Analyst II

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

Summary

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. The role partners closely with Fulfillment, Supply Chain, and Manufacturing teams to establish compliant processes, documentation, and oversight for regulated product distribution.

Roles & 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.

Education & Experience

• 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.