- Fujifilm (College Station, TX)
- …Qualifications, Traceability Matrices, and Validation Final Reports, ensuring documents meet regulatory and procedural requirements of 21 CFR Part-11, Annex-11 Data ... in Validation in a pharmaceutical, biotechnology, or related industry, preferably in FDA -regulated environments, OR; + Bachelor's Degree with 4+ years of direct… more
- Kelly Services (Coppell, TX)
- …improve efficiency and consistency including testing, inspection, and production. + Interact with Regulatory bodies, such as the FDA , to ensure compliance. + ... meet and exceed standards set by customers and any regulatory bodies for cosmetic and OTC products through the...is strongly preferred. + Must have exceptional knowledge of FDA regulations and Good Manufacturing Practice (GMP) regulations, along… more
- CSL Plasma (Port Arthur, TX)
- …This role will ensure compliance to training needs, SOPs, processes and other regulatory or company directives are adhered in order to support the operations and ... of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate… more
- Charles River Laboratories (Houston, TX)
- …of procedures, guidelines, and regulations governing import/domestic as mandated by applicable regulatory agencies (ie: CDC, USDA, FDA , EPA, and US Fish ... import and delivery of non-human primates, including extensive interaction with regulatory agencies including CDC, United States Department of Agriculture (USDA) and… more
- 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
- Fujifilm (College Station, TX)
- …points of the computerized system lifecycle, ensuring compliance with regulatory requirements, Computer Systems Validation (CSV) and Lifecycle procedures with ... Qualifications, Traceability Matrices, and Validation Final Reports, ensuring documents meet regulatory and procedural requirements of 21 CFR Part-11, Annex-11 Data… more
- Abbott (Austin, TX)
- …manufacturing processes and equipment, in accordance with applicable medical regulatory standards.25% + Performs process and equipment improvement and ... design controls and regulations for medical device development, (ISO134851, ISO13485, FDA ). + Strong technical experience in mechanical or chemical engineering with… more
- ARTIDIS (Houston, TX)
- …efficiency, and ensuring that our transformative technology consistently meets FDA requirements and internal quality benchmarks, ultimately supporting superior ... goods + Execute all local Quality Management activities in compliance with FDA Requirements + Ensure compliance assurance and monitoring related activities on site,… 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
- Bio-Techne (Austin, TX)
- …capabilities and unique technologies ranging from biomarker discovery to international regulatory expertise and the ability to launch innovative products as both ... Quality Management System in alignment with international quality and regulatory standards. **Key Responsibilities:** Provides support ensuring compliance with all… more