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

TTEvYmMyTFNGWGhLenJwZ25ueGcraVgzdmc9PQ==
  • 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

Remote work

Similar Jobs

Mark Firth Marketing LLC

Digital Content Specialist Job at Mark Firth Marketing LLC

 ...to join our team. You will lead our marketing efforts using new media and digital tools. Full training will...  ..., and there is no need for previous experience in this field or any technical...  ...strong online company voice through social mediaSuggest and implement direct marketing... 

Peoria Unified School District

CTE Film & TV Intern — Video Production Assistant Job at Peoria Unified School District

 ...District is looking for a CTE Student Intern to assist in creating promotional videos and collaborate on projects. Applicants should be in 11th or 12th grade, with a sample of video production work available for review. The role requires knowledge of Microsoft Office and... 

archny

High School Biology/Non-Regents Chemistry Teacher Job at archny

Position: High School Biology / Non-Regents Chemistry TeacherMoore Catholic High School is seeking a dedicated and engaging educator to teach Biology and Non-Regents Chemistry at the high school level. The ideal candidate will foster a dynamic, student-centered classroom... 

DNAM Brands

Fashion Paid Social Growth Specialist Job at DNAM Brands

DNAM Brands is seeking a creative, analytical Paid Social Marketing Associate in the Beverly Hills area to support and optimize paid social campaigns across Meta and TikTok Shop. You will work closely with the Paid Social Marketing Manager, Creative, E-commerce, and Brand... 

Agiliti Health

Inspection Engineer Job at Agiliti Health

 ...innovation, operational excellence, and developing talented team members who are passionate about solving complex challenges. As an Inspection Engineer, you will play a critical role in advancing our metrology and inspection capabilities through automation, software...