- Merck (Austin, TX)
- **Job Description** The Director of GMP Compliance will be a part of the Compliance Support and Remediation team within our company's Global Quality ... SMEs. **Job Function:** + serve as a subject matter expert for good manufacturing practices ( GMP ) for...authority/board of health as an inspector, investigator, product reviewer, compliance officer, or other GMP /regulatory role +… more
- Mentor Technical Group (College Station, TX)
- …technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. ... and troubleshoot issues throughout the plant. + Take on SME (Subject Matter Expert ) roles for multiple facility and equipment systems and engage in continuous… more
- Fujifilm (Austin, TX)
- …regard to biologically contaminated solid waste materials, serve as the subject matter expert for laboratory safety, be a resource to EHS teams for facility safety ... audits, and represent FDB as a biosafety subject matter expert . This role will have 7-10 direct and indirect...certifications, and related work experience. + Strong understanding of GMP principals and working within a quality centric organization… more
- Fujifilm (College Station, TX)
- …systems. **External US** **_Essential Functions:_** + Support validation as the Subject Matter Expert to ensure that appropriate regulations (eg 21 CFR Part 11 and ... phase and level. + Interface with IT to ensure GMP compliant integration with Corporate IT infrastructure. + Prepare,...laws, regulations and industry codes. + Responsible for ensuring compliance with cGMP practices utilized in bulk drug and… more
- Fujifilm (College Station, TX)
- …source of pride for the area. **_Summary_** **:** The Quality Assurance (QA) Compliance Analyst II, Supplier Quality will be responsible for supporting the supplier ... II will assist with ensuring all suppliers of raw materials, consumables, and GMP services are qualified prior to use within the facility. **External US**… more
- Fujifilm (College Station, TX)
- …and other drug substances. This person would become the subject matter expert on core manufacturing and operational technologies for the manufacturing unit. ... + Take the lead in investigating and resolving events that arise from compliance issues. + Assist in identifying improvement to and managing change in technology… more
- Kelly Services (Houston, TX)
- …are consistently met. + Ensure that clinical supplies meet regulatory, GCP, and GMP requirements, resolving supply-related issues as needed. + Serve as a liaison ... track clinical supply budgets and vendor invoicing to ensure financial transparency and compliance . + Other duties as assigned **Essential Details** + Full-time + Up… more
- Healgen Scientific Limited (Houston, TX)
- …are seeking a Manager/Director of Quality Assurance to support our Quality and Compliance team. This position is responsible for proving leadership for the Healgen ... of high-quality products from the manufacturing facilities, while maintaining compliance with the Healgen Scientific Quality Management System, and applicable… more
- BioBridge Global (San Antonio, TX)
- …the enterprise, fostering a culture of continuous improvement, operational excellence, and compliance . They will inspire teams, ensure high standards of quality and ... regulatory compliance , and focus on meeting revenue targets while optimizing...Duties and Responsibilities Essential Tasks Advanced Technical Leadership: Provide expert oversight on blood and plasma testing methodologies, ensuring… more
- ICU Medical (Austin, TX)
- …Subject Matter Expert (SME) for engineering documents, providing guidance for compliance and consistency when there is not total agreement of the requirements by ... . Serve as point of contact and subject matter expert in discussions or issues related to Oracle EAM....internal and external audit and investigation requests . Ensure compliance of PM information and other data to FDA… more
- Randstad US (Houston, TX)
- …the integrity and efficiency of our Quality Management System, ensuring compliance with industry standards, and facilitating various audit processes. The ideal ... - 27 per hour work hours: 9 to 5 education: Bachelors responsibilities: + Compliance Audits: + Create and modify the compliance audit schedule, including… more
- Eurofins (Houston, TX)
- …Testing (BPT) Group is the largest network of harmonized bio/pharmaceutical GMP product testing laboratories worldwide. Eurofins BPT provides comprehensive CMC ... understanding of regulatory requirements and a passion for helping clients maintain compliance and ensure the integrity of their operations. Regional Sales Manager… more