What are the responsibilities and job description for the Quality Assurance Associate II position at Careers Integrated Resources Inc?
Hybrid Role
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.
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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