- Abbott (Austin, TX)
- …and vendors. + Develops and implements engineering systems and procedures to ensure compliance with FDA , GMP, and other applicable regulations. + Ensures a ... safe work environment consistent with Environmental, Health & Safety requirements and company policies. **Required Qualifications** + Bachelor's degree in engineering or adjacent technical field. + 7-9 years of related work experience or an equivalent… more
- Houston Methodist (Houston, TX)
- …and meet quality requirements. + Conducts internal inspections and audits to ensure compliance with Federal Drug Administration ( FDA ) regulations and cGMP Core ... focus and application of positive language principles + Familiar with quality, compliance and FDA regulatory requirements for Good Laboratory Practice (GLP)… more
- Actalent (Fort Worth, TX)
- Job Title: Quality/Regulatory Manager Job Description The Head of Quality & Regulatory Affairs is responsible for leading and managing all aspects of quality ... assurance, regulatory compliance , validation, and document control. This role ensures that...recall activities. + Liaise with regulatory agencies such as FDA , Notified Bodies, and Health Canada. + Develop, implement,… more
- Biomat USA, Inc. (Odessa, TX)
- …daily activities of donor floor operations, supervising staff, and supporting compliance with regulatory and quality standards. The Senior Operations Supervisor acts ... of operational priorities, and provides direct support to the Center Manager in driving performance, donor satisfaction, and continuous improvement. **Primary… more
- Biomat USA, Inc. (Houston, TX)
- …daily activities of donor floor operations, supervising staff, and supporting compliance with regulatory and quality standards. The Senior Operations Supervisor acts ... of operational priorities, and provides direct support to the Center Manager in driving performance, donor satisfaction, and continuous improvement. **Primary… more
- CSL Plasma (Port Arthur, TX)
- …facility compliance with CSL procedures and policies, cGMP, OHSA, FDA , and other regulations, as applicable, and develop center responses for deficiencies. ... **The Opportunity** This position provides immediate support to the Assistant Manager of Quality in monitoring plasma center processes to ensure overall … more
- Biomat USA, Inc. (Corpus Christi, TX)
- …employees and supervise donor flow. * Learn and maintain thorough familiarity and compliance with all state and federal regulations, US Food and Drug Administration ... ( FDA )-approved Standard Operating Procedure Manual, Occupational Safety and Health...is performed. * Under the guidance of the Center Manager and/or the Assistant Manager , assure facility… more
- Kedplasma (Pharr, TX)
- …atmosphere, ensuring compliant plasma collections under the direction of the Center Manager . Operates within the scope of EU Guidance on Good Manufacturing Practice ... and FDA cGMP 21CFR. **ESSENTIAL JOB FUNCTIONS** Every effort has...the position. **MAIN DUTIES AND RESPONSIBILITIES** **Core** + Ensures compliance of all plasma collection center activities with SOPs… more
- Kedplasma (San Antonio, TX)
- …procedure and plasma collection, including donor set-up, monitoring and disconnect in compliance with Standard Procedures and FDA guidelines, as needed. + ... and screening donors under the direction of the Center Manager . Operates within the scope of EU Guidance on...scope of EU Guidance on Good Manufacturing Practice and FDA cGMP 21CFR. **ESSENTIAL JOB FUNCTIONS** Every effort has… more
- Medtronic (Dallas, TX)
- …as assigned/requested by management + All activities must be performed in compliance with the Quality System + Travel requirement (international possible): 20-40% ... in the operating room, so healthcare/surgical setting experience + Familiarity with FDA product requirements and regulatory guidelines + Experience with robotics or… more