Senior Quality Assurance Specialist, QMS Operations
About The Position
We’re looking for a passionate and curious Senior QA Specialist 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. As a Senior QA Specialist, you'll have the freedom to ask the hard questions, think outside the box, and find creative solutions that push us forward. It’s a role where your curiosity will fuel both your personal growth and the success of the team. This role is responsible for the execution of day-to-day QA responsibilities for GMP manufacturing, along with building and enhancing the quality assurance systems. The role incumbent works both independently and collaboratively with Manufacturing, Quality and Facilities staff to ensure compliance with cGMPs and internal procedures. The responsibilities of the employee is based on the assigned QA organization as outlined below.
Requirements
- Bachelor’s degree in biological or engineering science
- Minimum of 5 years relevant experience in a biopharmaceutical/Pharmaceutical cGMP manufacturing or similar environment.
- Ability to collaborate and communicate cross-functionally.
- Proven attention to detail
Responsibilities
- Review and assess 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 inputs and reviews on communication as to the status of deliverables to customers, management, and stakeholders.
- Develop, review, and deliver 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 and review 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.
- Alert senior management of significant quality, compliance, supply, and safety risks.
Benefits
- Growth Opportunities
- Flexible Work Environment
- Inclusive Culture
- Innovative Projects
- A Place for Big Ideas
- 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 and paid holiday, wellness and transportation benefits
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
1,001-5,000 employees
