Quality Assurance Analyst II Job at Katalyst Healthcares & Life Sciences, Indianapolis, IN

  • Katalyst Healthcares & Life Sciences
  • Indianapolis, IN

Job Description

Job-ID32181812Reference26-00478Summary: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 complianceEducation & 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

Job Tags

Similar Jobs

Postal service center

Mail Carrier - Rural in North Carver Job at Postal service center

 ...documentation How to Apply If this Rural Carrier Associate job opening matches the postal position you are researching near North Carver, MA, continue to the application page to check the current opening, estimated pay, eligibility requirements, schedule expectations,... 

Komando.com

Audio Engineer Job at Komando.com

 ...A Rare Chance to Work on a National Platform Right Here in PhoenixIf youve got audio chops, this is the opportunity of a lifetime. Were not just another podcast. The Kim Komando Show is a nationally syndicated tech radio show heard on over 510 stations, SiriusXM, podcasts... 

RCM Healthcare Services

Physical Therapist (PT, school-based) Job at RCM Healthcare Services

 ...Physical Therapist (PT, School-based) Compensation Range: $63-68/hour Location: Wyandotte, MI; Onsite School Setting Position Summary The School Physical Therapist will be assessing students' physical development level; providing appropriate treatment to... 

UPMC - Pittsburgh Medical Center

Sr. Professional Staff Nurse, BSN/NIGHTS - Emergency Department Job at UPMC - Pittsburgh Medical Center

 ...year at any accredited institution, available to employees and their dependents (plus discounts for UPMC employees including no cost RN-BSN/MSN options!)\n \n The Professional Staff Nurse is a valued step in the UPMC nursing career ladder, with opportunities for... 

N STREET VILLAGE INC

Health & Wellbeing Public Health Intern Job at N STREET VILLAGE INC

 ...Job Description Job Description Health and Wellbeing Public Health Intern Department/Program : Health and Wellbeing Reports...  ...Public Health, Community Health, Health Education, Health Promotion, or a closely related field. Interest in community health,...