Supplier Quality Assurance
Position Title: Supplier Quality Assurance Associate (Part-time, 32 hours/week)
Work Location: 100% Remote
Assignment Duration: 5 months
Work Schedule: 4 days/week, part-time role 32hrs — let’s start with Monday-Thursday working, and if the candidate requires a shift in days, communicate that ahead of time for coordination.
Position Summary: Provides GDP Quality Assurance support to Lead, Quality Assurance, US GDP by supporting the following activities:
++Key Responsibilities:++
- Annual supplier qualification
- Support 3PL activities
- a. Work Instruction Review/Approval
- b. Nonconformance reports/Incident Reports Review/Approval
- c. Quality discrepancy reports (Nonconformance Approval)
- d. GDP QA input for Business Review Management
- Upstream supply chain activities (product shipped from plants/suppliers to our organization 3PL)
- a. 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
- b. 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
++Qualification & Experience:++
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 our organization 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.