Quality Assurance Specialist
hace 3 semanas
Job Summary
Katalyst Healthcares And Life Sciences is seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of our products and processes, and for maintaining compliance with regulatory requirements.
Key Responsibilities
- Assist with the integration and support of quality regulations for drug, biologics, device, and combination products.
- Support project teams in planning, preparation, review, and approval of quality documentation.
- Complete and route change requests for process document creation, maintenance, and implementation.
- Create quality system documentation and specifications with guidance from technical teams.
- Assist with or co-lead audits of documentation, facilities, and equipment.
- Assist in the design of effective quality systems, procedures, and processes within cross-functional teams.
- Perform assessments to determine compliance with processes and regulations.
- Participate in training and education programs for various aspects of quality assurance.
Requirements
- Bachelor's degree in chemistry, pharmacy, biology, microbiology, engineering, or other technical/scientific area.
- 3+ years' experience in quality assurance, quality oversight, or relevant experience.
- Technical knowledge in quality, regulatory, process sciences, manufacturing operations, and GMP compliance requirements.
- Excellent communication and interpersonal skills.
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