Posted: 10/29/2025 Job Number: 41490

Job Description

Quality Assurance Associate

Responsibilities:

Provides GDP Quality Assurance support to Lead, Quality Assurance, US GDP ***GDP = Good Distribution Practice*** 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 our 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
Requirements:
- 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 Qualifications:
- 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.
Pay range is $40 - $55 per hour with full benefits available, including paid time off, medical/dental/vision/life insurance, 401K, parental leave, and more. Our compensation reflects the cost of labor across several US geographic markets. Pay is based on several factors including market location and may vary depending on job-related knowledge, skills, and experience.

THE PROMISES WE MAKE:

At Crystal Equation, we empower people and advance technology initiatives by building trust. Your recruiter will prep you for the interview, obtain feedback, guide you through any necessary paperwork and provide everything you need for a successful start. We will serve to empower you along the way and provide the path for your professional journey.

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Meet Your Recruiter

Scott Brasel

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