Quality Assurance Associate II
3 days ago
Hybrid Role
Shift: 1st Work Schedule: 8:00 am - 4:30 pm EST; Mon-Fri
• 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 client 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). Years Experience: 3-6 years
Minimum Education: Bachelor's Degree in Science related field.
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