- Houston Methodist (Houston, TX)
- …daily tasks **GROWTH/INNOVATION ESSENTIAL FUNCTIONS** + Participates with the Quality Assurance Manager and/or cGMP Core Director in defining quality policies. + ... as necessary **SERVICE ESSENTIAL FUNCTIONS** + Participates in internal audits and external inspections by Regulatory Agencies and reports...Assists Quality Assurance Manager , cGMP Core Director and/or team members… more
- Fujifilm (College Station, TX)
- …**_Summary:_** Fujifilm Diosynth Biotechnologies Texas (FDBT) is seeking an **eQMS Manager ** to lead the configuration, implementation, analysis, and maintenance of ... Quality Management Systems (eQMS)** . This role ensures compliance with ** cGMP , and regulatory requirements** while optimizing eQMS functionality and efficiency. The… more
- Fujifilm (College Station, TX)
- …and excipients, represents the QC Raw Materials team during regulatory and customer audits . The Manager models leadership competencies and aids in the ... **Position Overview** The **Raw Materials QC Manager ** is accountable for GMP compliant laboratory operations...team and laboratory maintains inspection readiness for customer visits, audits and regulatory inspections following cGMP guidelines… more
- Fujifilm (College Station, TX)
- …Return on Sales. The Manufacturing Director will be responsible for the cGMP production, manufacturing and systems that support the manufacture of virus-related ... manner. + Ensuring the full compliance to OSHA and cGMP regulations of the manufacturing operations at all times...and representing all manufacturing operations in pre-approval inspections, FDA audits and client audits . + Develop and… more
- Sumitomo Pharma (Austin, TX)
- …a dynamic, highly motivated, and experienced individual for the position of **Senior Manager , Clinical Supply Chain** . The Senior Manager , Clinical Supply Chain ... on study timing and in accordance with clinical protocols, cGMP , GCP, ICH, FDA, and other applicable international, federal,...CSC budget and forecast planning. + Participate in CMO audits and/or technical visits as required. + Represent Clinical… more
- BioLife Plasma Services (Spring, TX)
- …manufacturing is performed consistently according to current Good Manufacturing Practices ( cGMP ), the Shire Quality System, and other applicable regulations for a ... must also maintain complete and accurate records, in accordance with cGMP . ACCOUNTABILITIES Performs duties associated with Quality (including but not limited… more
- Fujifilm (College Station, TX)
- …and site SOPs to ensure regulatory compliance. **Reports to** Senior Manager , Quality Assurance **Work Location** College Station, TX **Company Overview** The ... quality assurance training programs for staff development. + Provide cGMP guidance to operations, QC and QA. + Lead...guidance to operations, QC and QA. + Lead client audits and regulatory inspections. + Utilize investigative techniques to… more
- Fujifilm (College Station, TX)
- …quality policies and site SOPs to ensure regulatory compliance. **Reports to** Manager , QA Compliance **Work Location** College Station, TX **Company Overview** The ... rational of those principles. + Knowledge and understanding of Computer cGMP regulations and practices pertaining to computer Compliance principles, manufacturing… more
- Fujifilm (College Station, TX)
- …QA liaison internally and externally. **Reports to** Director, Quality Assurance/Senior Manager , Quality Assurance **Work Location** College Station, TX (On-site at ... audit questionnaires + Lead vendor, supplier, contract laboratory and client audits + Identify process and Quality System improvement opportunities. + Provide… more
- Biomat USA, Inc. (San Antonio, TX)
- …Performs documentation review for unsuitable test results. * Assists the Quality Systems Manager to ensure that cGMP regulation, SOPs and regulatory requirements ... Associate** **Summary:** Under the direct supervision of the Quality Systems Manager , perform quality assurance and Training functions to ensure compliance with… more