What are the responsibilities and job description for the QA Specialist position at Katalyst Healthcares & Life Sciences?
Responsibilities and Requirements:
- This position will participate in Quality activities to ensure compliance with applicable quality objectives and regulatory requirements.
- This position is located at our El Segundo, CA site and report into the Sr. QA Manager, Quality Operations.
- Review batch-related documentation and ensure resolution of issues to release product.
- Perform comprehensive quality review of batches for disposition.
- Ensure process control measures are in place and followed in product manufacturing.
- Ensure all product-related Deviations are initiated, investigated and resolved.
- Ensure that associated CAPAs are initiated and resolved, as needed.
- Generate and update procedures, forms and other documents.
- Represent Disposition or QA Ops at plant and multi-site scheduling meetings.
- Provide QA representation at multi-site disposition meetings.
- Provide QA representation on projects and at team meetings.
- Maintain metrics related to product disposition in support of the Management Review and for continuous improvement.
- Support and participate in inspections and audits.
