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Quality Assurance Analyst

Lancesoft

Indianapolis, IN

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JOB DETAILS
SALARY
$50
SKILLS
Analysis Skills, Biology, Biotech and Pharmaceutical, Change Control, Communication Skills, Continuous Improvement, Cross-Functional, Distribution Channel, Distribution Management, Distribution Warehousing, Documentation, FDA (Food and Drug Administration), FDA Requirements, GxP, ISO (International Organization for Standardization), Internal Audit, Logistics, Logistics Processes, Maintain Compliance, Medical Equipment, Onboarding, Performance Analysis, Performance Metrics, Process Development, Process Improvement, Quality Assurance, Quality Metrics, Quality System Requirements (QSR), Record Keeping, Regulations, Risk Analysis, Standard Operating Procedures (SOP), Supply Chain, Supply Chain Operations, Team Player, Third-Party Logistics (3PL)
LOCATION
Indianapolis, IN
POSTED
30+ days ago
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.

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

Qualifications:
•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
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About the Company

L

Lancesoft

We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc). 

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.

COMPANY SIZE
2,000 to 2,499 employees
INDUSTRY
Staffing/Employment Agencies
FOUNDED
2000
WEBSITE
http://www.lancesoft.com/

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