
Quality Assurance Specialist
hace 6 días
**About the Role:**
We are seeking a highly skilled Quality Assurance Specialist to join our team at Flexible & Integrated Technical Services, LLC. As a key member of our organization, you will play a vital role in ensuring the highest standards of quality in the Drug Substance area.
**Responsibilities:**
- Review and approve product Masters Plans (MPs) to guarantee compliance with regulatory requirements.
- Approve process validation protocols and reports for manufacturing processes, ensuring seamless production operations.
- Lead investigations into incidents and anomalies, providing objective findings and recommendations for improvement.
- Represent QA on the New Product Introduction (NPI) team, collaborating with cross-functional teams to ensure successful product launches.
- Own site quality program procedures, maintaining up-to-date documentation and implementing best practices.
**Requirements:**
To be successful in this role, you must have a Bachelor's Degree with five (5) years of direct experience as a Quality Professional in the regulated industry. Your expertise should include bilingual project management skills, proficiency in SAP and LIMS, and experience with Change Control PASx/MES application, Risk assessment, MAXIMO, and NPI Validation process.
**Our Company Culture:**
FITS is a unique Service Provider company that prioritizes our employees' well-being and growth. We offer a flexible, family-oriented work environment that allows our team members to thrive professionally and personally. Join us in delivering top-notch quality talent to the Pharmaceutical, Medical Device, and Manufacturing industries.
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