Quality Assurance Associate

Just-Evotec is a forward-thinking company focused on innovation and success. They are seeking a passionate QA Associate to execute day-to-day QA responsibilities for GMP manufacturing and ensure compliance with regulatory standards.

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 but not limited to 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 that they are aligned with program strategy and regulatory requirements
• Ensure that 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
• Interpretate 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

Skills

• Bachelor's Degree 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

Benefits

• Discretionary annual bonus
• Comprehensive benefits to include Medical, Dental and Vision
• Short-term and long-term disability
• Company paid basic life insurance
• 401k company match
• Flexible work
• Generous paid time off
• Paid holiday
• Wellness and transportation benefits

Company Overview

Company H1B Sponsorship