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.
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