Quality Assurance Specialist
3 days ago
Excellis Health Solutions, LLC, a global strategic management consulting services firm, is seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for providing quality expertise to both our staff and external clients.
Key Responsibilities:
- Interpret and apply current regulations, including FDA regulations for Pharmaceutical and Medical Device products, to ensure compliance with quality standards.
- Conduct internal and external audits to evaluate the degree of quality compliance and conformance to regulatory requirements.
- Develop and recommend Corrective Action Preventive Action (CAPA) activities to address quality issues.
- Support the implementation of Quality Management Systems (QMS) and monitor risk management activities.
- Collaborate with project teams to ensure compliance requirements are understood and addressed in project deliverables.
Requirements:
- Proven experience in pharmaceutical and medical device regulatory affairs within the FDA regulated industry.
- Knowledge of DSCSA regulations for prescription pharmaceutical products and product launch regulations.
- Self-starter with the ability to work independently on a project-by-project basis.
- BS degree or higher in a relevant field.
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