- Biomat USA, Inc. (Corpus Christi, TX)
- …responsible for overseeing day-to-day operational performance to ensure donor safety, regulatory compliance, and achievement of production goals. This role provides ... all center activities align with company standards, SOPs, and applicable regulatory requirements. **Summary** : Assists with operational management of a Plasma… more
- Kedplasma (Houston, TX)
- …with cGMP, KEDPLASMA DCOP's and other Company standards and protocols to meet regulatory requirements of the FDA , EMEA, Customer Specifications, and other ... experience,_** **_education_** **_and certifications._** **JOB SUMMARY** Manages plasma collection centers' Quality staff and ensures quality standards are met… more
- United Therapeutics (Houston, TX)
- …compliance. The Director, DPF Site Operations role is pivotal in maintaining regulatory compliance, upholding the highest quality standards, and driving ... play a critical role in ensuring the production of high- quality organs for GMP use, including human transplantation. You...Experience interfacing with the US Food and Drug Administration ( FDA ) and, as appropriate, ex/US regulatory agencies… more
- Houston Methodist (Houston, TX)
- …methods specified in the study protocol and performing general administrative and regulatory duties supporting the study. This position will also support the ... Expanded access program is a potential pathway from the FDA for a patient with a serious or immediately...options are available. This position will work with the Regulatory Affairs Office, the IRB and the physicians to… 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 ... and procedures for various technologies. Must obtain a working knowledge of regulatory / quality requirements and perform within all Standard Operating Procedures… more
- Fujifilm (College Station, TX)
- …and implement microbiological quality control procedures to ensure compliance with FDA , EMA, and other relevant regulatory guidelines. + **Data Integrity** : ... regulatory standards. + **Cross-Functional Collaboration** : Work closely with the Quality Assurance, Manufacturing, and Regulatory Affairs teams to support… more
- Kedplasma (Pharr, TX)
- …center activities with SOPs and other company standards and protocols to meet the regulatory requirements of the FDA , EMEA, customer specifications and other ... scope of EU Guidance on Good Manufacturing Practice and FDA cGMP 21CFR. **ESSENTIAL JOB FUNCTIONS** Every effort has...service. + Identifies potential, serious, or chronic problems affecting quality of compliance. + Maintains a clean, orderly, and… more
- Abbott (Plano, TX)
- … requirements. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, ... components and products in accordance with policy and procedures. Assists Supplier Quality Engineering with technical inspection support. **What You'll Work On** +… more
- Veterans Affairs, Veterans Health Administration (San Antonio, TX)
- …ensuring adherence to established methodologies, standard operating procedures, and regulatory standards. Leads quality management initiatives, integrating ... technology. Preferred Experience: Minimum 3 years Supervisory Experience Experience with Quality Assurance Program Experience with Regulatory and Accrediting… more
- 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