Overview
Remote Quality Assurance Associate Jobs in United States at Planet Pharma
Title: Remote Quality Assurance Associate
Company: Planet Pharma
Location: United States
***32hrs/week – 4days/week***
12 Month Contract (May extend or convert to permanent)
$50/hour – $60/hour W2 (Depending on education, location, and previous experience)
ESSENTIAL JOB DUTIES:
Provides GDP Quality Assurance support to Lead, Quality Assurance, US GDP by supporting the following activities:
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 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
REQUIRED:
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 company 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.
PREFERRED:
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.
