Katalyst CRO
Join to apply for the
Quality Assurance Associate
role at
Katalyst CRO . Support the timely review of all GMP documents (batch records/analytical specifications, data, validation protocols/reports, COAs, deviations, change controls, etc.) to ensure alignment with quality and regulatory expectations prior to release and/or approval. Maintain organization of project deliverables for external partner projects using applicable tools. Identify and communicate quality risks proactively and collaboratively, maintaining the business interests of the organization and considering suitable outcomes 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 the Quality Focal Point to represent the site on CMC Quality sub-team(s) for assigned project(s). Responsibilities
Support the timely review of all GMP documents (batch records/analytical specifications, data, validation protocols/reports, COAs, deviations, change controls, etc.) to ensure alignment with quality and regulatory expectations prior to release and/or approval. Maintain organization of project deliverables for external partner projects using applicable tools. Identify and communicate quality risks proactively and collaboratively, maintaining the business interests of the organization and considering suitable outcomes 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 the Quality Focal Point to represent the site on CMC Quality sub-team(s) for assigned project(s). Requirements
Knowledge of EU and FDA guidance. Experience in a GMP environment. Aseptic processing experience. Project Management experience preferred. Bachelor's degree in a science-related field. Minimum of 6+ years of experience. Seniority level
Mid-Senior level Employment type
Contract Job function
Quality Assurance Industries
Pharmaceutical Manufacturing
#J-18808-Ljbffr
Quality Assurance Associate
role at
Katalyst CRO . Support the timely review of all GMP documents (batch records/analytical specifications, data, validation protocols/reports, COAs, deviations, change controls, etc.) to ensure alignment with quality and regulatory expectations prior to release and/or approval. Maintain organization of project deliverables for external partner projects using applicable tools. Identify and communicate quality risks proactively and collaboratively, maintaining the business interests of the organization and considering suitable outcomes 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 the Quality Focal Point to represent the site on CMC Quality sub-team(s) for assigned project(s). Responsibilities
Support the timely review of all GMP documents (batch records/analytical specifications, data, validation protocols/reports, COAs, deviations, change controls, etc.) to ensure alignment with quality and regulatory expectations prior to release and/or approval. Maintain organization of project deliverables for external partner projects using applicable tools. Identify and communicate quality risks proactively and collaboratively, maintaining the business interests of the organization and considering suitable outcomes 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 the Quality Focal Point to represent the site on CMC Quality sub-team(s) for assigned project(s). Requirements
Knowledge of EU and FDA guidance. Experience in a GMP environment. Aseptic processing experience. Project Management experience preferred. Bachelor's degree in a science-related field. Minimum of 6+ years of experience. Seniority level
Mid-Senior level Employment type
Contract Job function
Quality Assurance Industries
Pharmaceutical Manufacturing
#J-18808-Ljbffr