- Houston Methodist (Houston, TX)
- …be responsible for all aspects of compliance associated with the quality operations including, but not limited to, review of procedures, verification of equipment ... a highly regulated radiopharmaceutical drug manufacturing facility in compliance with FDA cGMP guidance. **PEOPLE ESSENTIAL FUNCTIONS** + Provides work direction of… more
- Houston Methodist (Houston, TX)
- …senior team members with aspects of compliance associated with the quality operations including but not limited to; review of procedures, verification of equipment ... internal inspections and audits to ensure compliance with Federal Drug Administration ( FDA ) regulations and cGMP Core policies and procedures. + Assists with… more
- Baylor Scott & White Health (Dallas, TX)
- …Accreditation of Cellular Therapy (FACT) standards, Food and Drug Administration ( FDA ) regulations, Institutional Review Board (IRB) requirements, 3 rd -Party ... Program. **ESSENTIAL FUNCTIONS OF THE ROLE** + Assists the Manager of Quality Assurance and Regulatory Affairs in the...Supports and ensures quality assurance in all aspects of operations for the CT / BMT Program. + Provides… more
- Fujifilm (College Station, TX)
- …providing and maintaining status updates for validation activities related to day-to-day operations or project work + Able to work independently with minimum ... guidance from Sr. Engineers and/or CSV Manager (author protocol, execute, analyze data, author reports). +...in a pharmaceutical, biotechnology, or related industry, preferably in FDA -regulated environments, OR; + Bachelor's Degree with 4+ years… more
- Fujifilm (College Station, TX)
- …objectives are met. + Responsible for participating and representing all manufacturing operations in pre-approval inspections, FDA audits and client audits. + ... facility in the highest level of cGMP compliance per FDA and customer expectations. + Build, maintain and motivate...following positions will directly report to the Manufacturing Director: Manager Upstream Operations , Sr. Manager … more
- ThermoFisher Scientific (Austin, TX)
- …knowledge of clinical trial processes and expertise / knowledge of clinical study operations Knowledge of FDA regulations and ICH GCP guidelines Knowledge of ... and in the future. Location/Division Specific Information Our global Clinical Operations colleagues within our PPD(R) clinical research services provide end-to-end… more
- Houston Methodist (Houston, TX)
- …is responsible for supporting multiple projects under supervision of Clinical Trial Manager which may include clinical research protocols, gathering patient data via ... research support functions as assigned by the clinical trial manager including but not limited to informed consent for...or storage at site per the study manual of operations . **QUALITY/SAFETY ESSENTIAL FUNCTIONS** + Completes required case report… more
- Sysco (Dallas, TX)
- …any manner capable of during emergencies the plant President or GM (general manager ) determines are paramount to the business. + Frequently interacts with the ... following: SSMC/SSSC Personnel, Operations , Sales, Transportation and Maintenance as well as Sysco...Formal job training in TQM principles, SPC, HACCP concepts, CFIA/ FDA regulations would be beneficial. + Formal quality and… more
- Daisy Brand (Garland, TX)
- …Supplement new technology and process implementation. Develop and/or enhance current operations and maintain technicians training. This role directly reports to the ... the Packaging Department Manager . The Manufacturing Systems Engineer (Packaging) is responsible for...reports compared against the expected budget. + Conduct pertinent operations record reviews. Assess deviations using statistical analysis and… more
- HCA Healthcare (Houston, TX)
- …reports and determine allocation + Perform other duties as assigned by Pharmacy Operations Manager **What qualifications you will need:** + Bachelor of Science ... this role:** + Under the direction of the Pharmacy Manager , oversee operations and coordinate workflow of...adherence to all Board of Pharmacy, JCAHO, CMS and FDA standards + Perform all pharmacy technician duties as… more
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