Manage Quality Assurance and Regulatory Affairs for HemaCare Corporation operations following Quality Systems, current Good Manufacturing Practices (cGMPs), current Good Tissue Practice (cGTPs), and in adherence with all applicable Federal, State, local, international, and industry regulations and standards. Must have a good understanding of regulatory compliance frameworks applicable to blood banking, cellular therapy and human subject research protection requirements.
Responsible for monitoring compliance with all applicable regulations: local, State, Federal, International, FDA, AABB, OSHA and other applicable agencies.
Monitor compliance through performing internal audits, managing deviations, review and approval of standard operational procedures (SOPs), master batch records, validation plans, other controlled documents and the review and assessment of Quality Systems reports.
Provide consultation for operations concerning IRB approvals, regulations, appropriate standard operating procedures, and validation protocols.
Prepare for, facilitate and participate in quarterly Quality Management Meeting and routine Change Control Meetings.
Perform internal audits, manage results and report results to executive management.
Participate as a team member or serve as project lead and manage quality improvement projects.
Support cross-functional project teams in the development and implementation of validation plans and protocols.
May serve as Quality support in cross-functional GMP project teams
Develop, review, and revise general QA department (QMS) SOPs.
Perform final QA batch record reviews for the release of GMP products.
Perform QA disposition of incoming materials.
Review manufacturing, environmental monitoring, and quality control data for in process and finished products.
May perform Quality functions in the cleanroom following applicable gowning procedures.
Assist or lead special projects as assigned.
Performs all other duties, at the discretion of management, as assigned.
Quality Management Activities
Regulatory Management Activities
Supplier / Vendor Management Activities
Validation Management Activities
Donor Deferral and Document Control Management Activities
Training Management Activities
EDUCATION AND REQUIREMENTS
Bachelor’s degree in biological science discipline preferred. In lieu of degree, seven to ten years of comparable progressive experience is required. Advanced degree is a plus.
Seven to ten years of progressive quality or manufacturing experience in cell therapy, pharmaceutical, biotech, or biologics operations preferred.
Strong working knowledge and ability to apply GMPs and GTPs in conformance to FDA, EU and AABB standards.
Must have a good understanding of regulatory compliance frameworks applicable to blood banking, cellular therapy and human subject research protection requirements.
Thorough understanding of key supporting quality systems including document management, training, change control, deviation, non-conformance, and CAPA. Requires expertise in performing root-cause analysis.
Demonstrates excellence in all communication and interpersonal skills; able to develop and maintain cooperative working relationships with other staff members, management, and customers.
Internal Number: 2582
About HemaCare a Charles River Company
HemaCare is a global leader in the customization of human-derived biological products and services for biomedical research, drug discovery, process development, and cell and gene therapy starting material. HemaCare relocated its operations and corporate headquarters to a larger, state-of-the-art facility with four GMP-compliant cleanrooms in the city of Northridge. CA.