Quality Assurance Analyst II
Katalyst HealthCares & Life Sciences
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
Vacancy posted 1 day ago
Similar jobs that could be interesting for youBased on the Quality Assurance Analyst II in Indianapolis, IN vacancy
- ...State- based Exchange oversight team as a Quality Assurance Specialist. This candidate is highly... ...with project coordinators and business analysts as well as SharePoint developers to support... ...Skills • Knowledge of CMMI Level II/III, IEEE or other software development...SuggestedContract workWork at office
- Overview Knowledge Services is seeking a Senior Quality Assurance Analyst (QA) for a long-term project in support of the State of Indiana. Applicants must be currently local to Indianapolis and able to work a hybrid work schedule and be onsite weekly working downtown...SuggestedLocal areaWork visaShift work
Knowledge Services
Indianapolis, IN4 days ago - ..., and test cases. They will be expected to define and track quality assurance metrics such as defect densities and open defect counts as well... ...cross functional groups including, developers, business analysts, project managers, and business leaders throughout the 2-3 week...SuggestedWork at office
- Get AI-powered advice on this job and more exclusive features. Squadware Inc is hiring a Software Quality Assurance Analyst for a consulting position with one of our clients on the north side of Indianapolis. This role is full time and can be a 1099 contract or w-2 position...SuggestedFull timeContract workRemote workRelocation
- ...Position: QA Analyst Location: Indianapolis, IN 46202 Client: State of Indiana Duration: 12+ Months Job Description... ...for LIMS (STARLIMS) integration Design and verify quality program standards based on EPA chemistry methods Review programs...Suggested
$29.52 per hour
Title/Role: Quality Assurance Analyst - Exp in Manufacturing Industry Worksite Address: Indianapolis, IN Pay Rate: $29.52/hr Job Summary Works with developers and chemists to ensure all quality assurance requirements are captured in the correct electronic formats, with...Flexible hours- ...LIMS), STARLIMS. Writes, revises, and verifies standards for quality program based on EPA chemistry test methods understanding the... ...chemists for about 60 methods. EXPERIENCE DESCRIPTION Quality Assurance Analyst capabilities with approximately 1-3 years of experience in...Contract workFlexible hours
$25.34 - $29.52 per hour
...Job Description Job Description Job Description: QA Analyst Laboratory Information Management System (LIMS) Job Title: QA Analyst... ...We are seeking a detail-oriented QA Analyst to support quality assurance, laboratory data validation, and system testing activities within...Hourly payContract workVision Square Inc
Indianapolis, IN16 days ago- ...Job Description Job Description Role: QA Analyst-Senior Duration: 9 Months with possible Extension (Convert to a full-time opportunity... ...manager. Perform complex workflow analysis and recommends quality improvements. Recommend new and improved QA practices and...Full timeRemote work
Info Way Solutions LLC
Indianapolis, IN2 days ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Quality Assurance Analyst II. Be the first to apply!
Related searches
- qa analyst Indianapolis, IN
- quality assurance analyst Indianapolis, IN
- quality lead Indianapolis, IN
- quality inspection Indianapolis, IN
- quality intern Indianapolis, IN
- aerospace quality Indianapolis, IN
- water quality scientist Indianapolis, IN
- supplier quality Indianapolis, IN
- air quality Indianapolis, IN
- quality environment health safety manager Indianapolis, IN