Quality Assurance Associate
Evotec is a forward-thinking company that thrives on curiosity and innovation. They are seeking a passionate QA Associate to drive impactful projects and ensure compliance with GMP manufacturing 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