Program Manager - Quality Assurance Officer-(170001O4)
The University of Maryland, Baltimore (UMB), School of Medicine, Office of Research and Graduate Studies (ORAGS) is currently recruiting for a Program Manager - Quality Assurance (Research Quality Specialist). This Program Manager - Quality Assurance will be responsible for monitoring studies to assure management that the facilities, equipment, personnel, methods, practices, records and controls are in conformance with appropriate regulations including, but not limited to Good Manufacturing Practice (21CFR210/211), Good Laboratory Practice (21 CFR Part 58), Electronic Records, Electronic Signatures (21 CFR Part 11 and other local, state or federal regulations.
UMB offers a generous benefits package that includes 22 vacation days, 14 floating and holidays, 15 sick days; comprehensive health insurance and retirement options; and tuition remission for employees and their dependents at any of the University System of Maryland schools.
Provide guidance for GMP program development and implementation. Identify necessary SOPs and data collection forms.
Guide development of and review equipment records, SOPs and validations.
Provide group and one-on-one GMP training. Review training records. Prepare periodic status reports of GMP studies for management.
Determine that no deviations from approved protocols or SOPS were made without proper authorization and documentation.
Evaluate protocols for compliance with appropriate regulations and SOPs. Inspect critical phases of on-going studies for compliance with the study protocol, SOPs and regulations. Perform final report and data audits. Prepare written reports for each audit/inspection.
Review all SOPs for compliance with regulations, readability, good documentation practices and compatibility to related SOPs. Interact with regulatory inspectors/auditors.
Conduct facility inspections, on-site and off-site, to assure conformance with regulations.
Maintain Quality Assurance records and files.
Education: Bachelor's degree (Master's preferred) in Biology or related field.
Experience: Minimum of four (4) years of related experience.
License/Certification: Quality Assurance
(RQAP) GLP Certification, ASQ certification. American Association of Laboratory Animal Science (AALAS) Certification a plus. Understanding of GDP, GMP and GCP.
Hiring Range: Commensurate with education and experience
If accommodations are needed for a disability, please contact Staffing & Career Services at 410-706-2606, Monday – Friday, 8:30am – 4:30pm EST. Maryland Relay can be accessed by dialing 711 (in-state) or 1-800-735-2258.
Equal Opportunity/Affirmative Action Employer. Minorities, women, protected veterans, and individuals with disabilities are encouraged to apply.
The University of Maryland, Baltimore (UMB) is the State's public health, law and human services university devoted to excellence in professional and graduate education, research, patient care, and public service. As a diverse community of outstanding faculty, staff and students, and using state-of-the-art technological support, we educate leaders in health care delivery, biomedical science, globa...l health, social work and the law. We emphasize interdisciplinary education and research in an atmosphere that explicitly values civility, diversity, collaboration, teamwork and accountability. By conducting internationally recognized research to cure disease and to improve the health, social functioning and just treatment of the people we serve, we foster economic development in the City, State, and nation. We are committed to ensuring that the knowledge we generate provides maximum benefit to society and directly enhances our various communities.