Quality Assurance Specialist
18 hours ago
We are seeking a highly skilled Quality Assurance Specialist to join our team at Katalyst Healthcares and Life Sciences. The successful candidate will be responsible for ensuring the quality and compliance of our pharmaceutical, biological, and device products.
Key Responsibilities- Assist with the integration and support of quality regulations, including 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, following approved templates and guidelines.
- 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 to ensure compliance and efficiency throughout our quality system.
- Perform assessments to determine compliance with processes and regulations, identifying potential gaps and implementing improvements within our quality system.
- Participate in training and education programs for various aspects of quality assurance.
- Bachelor's degree in chemistry, pharmacy, biology, microbiology, engineering, or other technical/scientific area preferred.
- 3+ years' experience in quality assurance, quality oversight, or relevant experience.
- Technical knowledge in quality, regulatory, process sciences, manufacturing operations, and QA systems, with a focus on GMP compliance requirements.
- Knowledge and familiarity with product, process, equipment, and facilities of pharmaceutical, biological, or device-related products preferred.
- Excellent communication and interpersonal skills, with the ability to work effectively in teams and independently.
- Strong organizational and time management skills, with the ability to prioritize tasks and meet deadlines.
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Quality Assurance Specialist
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