Note: The job is a remote job and is open to candidates in USA. Integrated Resources, Inc (IRI) is seeking a Quality Assurance Associate to provide GDP Quality Assurance support. The role involves supplier qualification, supporting 3PL activities, and managing documentation related to GDP QA processes.

Responsibilities

Provides GDP Quality Assurance support to Lead, Quality Assurance, US GDP
Annual supplier qualification
Support 3PL activities
Work Instruction Review/Approval
Nonconformance reports/Incident Reports Review/Approval
Quality discrepancy reports (Nonconformance Approval)
GDP QA input for Business Review Management
Upstream supply chain activities (product shipped from plants/suppliers to Client 3PL)
Temperature Excursion Management, including but not limited to approval of temperature deviations for shipments sent to 3PL and update of the temperature excursion handling process
Product Damage Management, including but not limited to approval of deviations for shipments sent to 3PL and update of the product damage handling process
Document Management and archival of the GDP QA documents in Veeva/eQMS
Supports with any GDP related activities

Skills

BA / BS in a science field, with minimum 5 years of pharmaceutical industry experience, minimum 3 years of QA experience.
Knowledge of GDP and other relevant regulations, as required, with a broad knowledge of quality principles and industry trends.
Effective written and oral communication and interpersonal skills, facilitation, and influencing skills with an ability to effectively work across the Client groups and with external stakeholders.
Must be a self-starter, proactive and have the ability to manage department resources to achieve the desired outputs on a daily basis.
Experience using GxP Documentation systems (Such as Trackwise (Digital), Veeva, SAP systems).
Direct experience in Quality Assurance function, GDP preferred
Working knowledge of global industry standards and regulatory requirements (e.g., US, EU and Japan).
Proficient with MS Excel, WORD, PowerPoint.

Company Overview

Integrated Resources Inc. It was founded in 1996, and is headquartered in Edison, New Jersey, USA, with a workforce of 501-1000 employees. Its website is http://irionline.com.

Company H1B Sponsorship

Integrated Resources, Inc ( IRI ) has a track record of offering H1B sponsorships, with 7 in 2025, 5 in 2024, 13 in 2023, 9 in 2022, 25 in 2021, 39 in 2020. Please note that this does not guarantee sponsorship for this specific role.

[Remote] Quality Assurance Associate- (Supply Chain/Distribution)

Job Type