- University of Texas Rio Grande Valley (Mcallen, TX)
- …communicates with the Institutional Review Board regarding the procedural and regulatory requirements of human subjects' research. + Plans, reviews, assesses, and ... non-regulated studies and studies that are deemed exempt from federal regulatory compliance. + Coordinates and processes reliance agreements for multi-site research;… more
- BioBridge Global (San Antonio, TX)
- …and product related. Assist and develop testing procedures according to organizational and regulatory (NMDP, AABB, FACT, ISO, FDA , and cGMP) standards. Assist ... advanced therapies. Leveraging its showcase facility designed to be compliant with FDA , EMEA, and PMDA production requirements, BBG Advanced Therapies focuses on… more
- Veterans Affairs, Veterans Health Administration (San Antonio, TX)
- …and maintains policies, procedures, and process control documents to meet all regulatory and accrediting bodies' requirements (eg, AABB, CAP, TJC, CLIA, FDA ... ensuring adherence to established methodologies, standard operating procedures, and regulatory standards. Leads quality management initiatives, integrating laboratory QA/QC… more
- Sumitomo Pharma (Austin, TX)
- …but not limited to, Clinical Development, Translational Medicine/Early Development, Regulatory Affairs, Data Management and Biostatistics is essential. **Job Duties ... as required. + Coordinate responses to ad hoc safety issues such as regulatory authority, site, or health care professional requests, along with PV physician,… more
- Biomat USA, Inc. (Houston, TX)
- …activities of donor floor operations, supervising staff, and supporting compliance with regulatory and quality standards. The Senior Operations Supervisor acts as a ... all state and federal regulations, US Food and Drug Administration ( FDA )-approved Standard Operating Procedure Manual, Occupational Safety and Health Administration… more
- Kedplasma (Houston, TX)
- …Manager. Operates within the scope of EU Guidance on Good Manufacturing Practice and FDA cGMP 21CFR. **ESSENTIAL JOB FUNCTIONS** Every effort has been made to make ... monitoring and disconnect in compliance with Standard Procedures and FDA guidelines, as needed. + Monitors the safety and...collection center for audits. + Follows all SOPs and regulatory policies and procedures, including the employee handbook. +… more
- Kedplasma (Lubbock, TX)
- …within the scope of EU Guidance on Good Manufacturing Practice and FDA cGMP 21CFR. **ESSENTIAL JOB FUNCTIONS** Responsible for performing venipuncture on donors ... scope of EU Guidance on Good Manufacturing Practice and FDA cGMP 21CFR. **MAIN DUTIES AND RESPONSIBILITIES** **Core** +...supplies are available as needed. + Follows all SOPs, regulatory policies, and procedures, including the employee handbook. +… more
- BioBridge Global (San Antonio, TX)
- …advanced therapies. Leveraging its showcase facility designed to be compliant with FDA , EMEA, and PMDA production requirements, BBG Advanced Therapies focuses on ... related experience. **Knowledge** Must have a working knowledge and understanding of FDA regulations and current Good Manufacturing Practices (cGMPs). Must acquire a… more
- MD Anderson Cancer Center (Houston, TX)
- …*1. * *A**d**ministration* * Must assure compliance with standards of CAP, JCAHO, FDA , Medicare, and CLIA. * Must give theoretical guidance and technical assistance ... which he/she is working complies with the CAP, JCAHO, FDA , Medicare, and CLIA regulations for accreditation. * Must...a diverse patient population and adherence to legal and regulatory requirements; and * Employee demonstrates a commitment to… more
- MD Anderson Cancer Center (Houston, TX)
- …that the laboratory in which he/she is working complies with the CAP, JCAHO, FDA , Medicare, and CLIA regulations for accreditation. . Must be able to identify and ... service. Administrative . Must assure compliance with standards of CAP, JCAHO, FDA , Medicare, and CLIA. . Must give theoretical guidance and technical assistance… more