Quality Assurance Analyst II

Katalyst CRO; Indianapolis (IN); On-site; USD 60,000 - 80,000; Full time

Job summary

Katalyst CRO is seeking a Quality Associate to support 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 Operations teams to establish compliant processes and documentation.

The successful candidate will oversee vendor qualification activities, support CAPAs, and help maintain

Qualifications

• Bachelor's degree in Quality, Life Sciences, Engineering or 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

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

Skills

GxP knowledge

Documentation

Cross-functional collaboration

Quality systems

Regulatory audits

Education

Bachelor's degree in Quality, Life Sciences, Engineering

Tools

Quality Management System (QMS)

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

• 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

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. This role partners closely with Fulfillment, Supply Chain, and Manufacyturing 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