Department:
Stem Cell Therapy Center -----
Stem Cell Therapy Center Position Title:
Quality Assurance Associate - Midwest Stem Cell Job Family Group:
Professional Staff Job Description Summary:
The Quality Assurance Associate performs all aspects of quality assurance and regulatory work as related to the operation of the GMP facility within the Midwest Stem Cell Therapy Center at KUMC. The role follows established standards and regulatory practices to keep the facility in full compliance with the FDA and other regulatory authorities. Assists with the development, review, revision, and maintenance of Standard Operating Procedures (SOPs), forms, and other quality system documents as needed. Job Description:
Key Roles and Responsibilities:
Performs all quality assurance and regulatory responsibilities associated with the operation of the Good Manufacturing Practice (GMP) and Good Tissue Practice (GTP) facility within the Midwest Stem Cell Therapy Center at KUMC.
Perform all work in compliance with all established standards and regulatory practices to keep the facility in full compliance with the FDA and other regulatory authorities.
Under the direction of Associate Director, Midwest Stem Cell Therapy Center, document, develop, update, and modify the various Standard Operating Procedures and other quality system documents as often as necessary based on change in protocols.
Maintain a thorough knowledge and be well versed in all applicable FDA regulations, especially those pertaining to manufacturing and controls, (cGMPs 21 CFR 210 and 211) and tissue regulation (cGTPs 21 CFR 1271).
Responsible for QA aspects of clinical supply manufacturing, testing, packaging, storing and shipping operations.
Assists with document management and batch record review.
Perform and maintain internal audit/review systems.
Responsible for equipment and GMP environment maintenance.
Assists with documenting and investigating deviations, nonconformances, CAPAs, and other quality events.
Will maintain relevant logbooks and ongoing documentation as required by the procedures and practices within the GMP facility
Assist in training of all employees and management of training records and reports.
Conducts activities in a professional and ethical manner, and in accordance with KUMC Policies and applicable local, state and federal laws and regulations.
Performs job responsibilities in a safe and secure manner.
Coordinate work with other University areas ensure integration and support of the University mission.
Develops, maintains and expands job-specific knowledge and skills to keep pace with industry changes and supports the university's commitment to excellence and innovation.
Participates in relevant committees, task force, or other similar activities.
Maintain confidentiality of medical center, employee, and patient information. Manages sensitive data with discretion and in accordance with KUMC policies and legal requirements.
This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. It is only a summary of the typical functions of the job, not an exhaustive list of all possible job responsibilities, tasks, duties, and assignments. Furthermore, job duties, responsibilities and activities may change at any time with or without notice.
Required Qualifications
Work Experience:
Four (4) years of experience working in a regulated laboratory or manufacturing environment, such as GMP, GTP, CLIA, CAP, FDA-regulated, or equivalent settings. Education may substitute for experience on a year for year basis.
Preferred Qualifications
Education
Bachelor's degree in biology, life science or a related field.
Work Experience:
Experience in a GMP environment for the manufacture of cellular therapy products
Experience and working knowledge of FDA regulations, especially those pertaining to current Good Manufacturing Practices (cGMP; 21 CFR Parts 210 and 211) and…