What are the responsibilities and job description for the Quality Assurance Associate position at Katalyst Healthcares and Life Sciences?
Responsibilities :
- Support timely review of all GMP documents (batch records / analytical specifications, data, validation protocols / reports, COAs, deviations, change controls, etc.) and ensure alignment with quality and regulatory expectations prior to release and / or approval.
- Maintain organization of project deliverables for external partner project using applicable tools.
- Identify and communicate quality risks in a pro-active and collaborative manner maintaining the business interests of the Organization and consideration of suitable outcome for the projects.
- Participate in and support batch associated deviations, risk assessments, and change controls in compliance with SOPs and company policies.
- Develop trusting team partnerships to ensure highly collaborative project outcomes.
- Act as Quality Focal Point to represent site on CMC Quality sub-team(s) for assigned project(s).
Requirements :
