Quality Assurance Associate

Role Summary

We’re looking for a passionate and curious QA Associate to join our team. If you’re excited by new challenges, solving complex problems, and learning every step of the way, you might just be the perfect fit. In this role, you’ll have the opportunity to drive impactful projects, collaborate with bright minds, and explore uncharted territories.

Responsibilities

• Review executed Manufacturing Batch Records.
• Participate in compliance walkthrough of the Manufacturing floor and other assigned areas.
• Partner with Manufacturing to ensure compliance in Manufacturing operations.
• Review and approve Master Batch Records and other supporting documents.
• Execute process performance and product quality monitoring programs.
• Alert senior management of potential deviations or compliance risks.
• Initiate and review all quality events of eQMS (Deviations, Change Control, CAPA, Risk Assessment, Management Review, Complaint Investigation, Product Quality Review, etc.) to assure compliance with regulatory and Just-Evotec Global Quality Management Systems (G-QMS) requirements.
• Provide input on communication as to the status of deliverables to customers, management, and stakeholders.
• Assist with developing training regarding QMS process or system changes.
• Support QA QMS in internal and external client audits and regulatory inspections (including SME for QMS processes and individual records).
• Monitor effectiveness for QMS through trending, analysis, and metrics; report to top management and G-QMS on the performance of the KPIs and identify opportunities for continuous improvement.
• Lifecycle management of the stability program for clinical and commercial products.
• Act as the QA representative on cross-functional product teams to integrate stability activities with project milestones.
• Support the design of stability protocols to ensure alignment with program strategy and regulatory requirements.
• Ensure stability studies are executed according to protocol.
• Review, verification, disposition, and archival of stability study data for assigned programs.
• Escalate unexpected data trends, OOS events, and risks appropriately, and drive/support resolution.
• Interpret stability results to support expiry, trending, and conditions of products.
• Support product stability related content in regulatory submission, including responses to questions and post-marketing.

Qualifications

• Bachelor's Degree in biological sciences, chemistry, biochemistry, engineering, or related life science field and 1 year of relevant quality experience OR Associate’s degree and 3 years of relevant quality experience OR High school diploma / GED and 6 years of relevant quality experience.
• Strong attention to detail.
• Ability to collaborate and communicate cross-functionally.

Skills

• Quality assurance and GMP/compliance knowledge
• Experience with eQMS and regulatory quality systems
• Analytical mindset with ability to interpret data and trends

Education

• See Qualifications above for degree requirements.