- General Dynamics Information Technology (Fort Detrick, MD)
- …provide input regarding manufacturing compliance requirements of the effort. + Conduct Quality Assurance reviews of GMP manufacturing related documents (SOPs, ... to make a personal impact as a **Manufacturing Operations Quality Advisor** supporting the _Defense Health Agency ._ GDIT...products in development follow Good Manufacturing Practices (cGMPs) per FDA 21 CFR (Code of Federal Regulations). **HOW YOU… more
- Catalent Pharma Solutions (Harmans, MD)
- …of life-enhancing and life-saving treatments for patients annually. Our FDA -licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies is located ... Technology Corridor, top universities, and government agencies. The Harmans/BWI-1 EMA and FDA approved facility, at approximately 200,000 sq. ft., houses 10 CGMP… more
- Guidehouse (Bethesda, MD)
- …monitoring. + Review records related to the general operation and upkeep of a GMP Quality Control laboratory, including but not limited to, QC test data, ... laboratory's Sterility Testing Service to ensure cGMP compliance with FDA regulations. + Provide oversight of Quality ...procedures and industry best practices. + Participate in the GMP training of new employees and contractors, as required.… more
- Terumo Medical Corporation (Elkton, MD)
- …of quality management systems and regulatory standards (eg, ISO, GMP ). + Proficient in document management software and methodologies. + Exceptional writing ... Sr. Quality Systems Documentation Specialist Date: Aug 18, 2025...and fully compliant with company policies, ISO 13485, and FDA regulations. + Document Review and Approval: Review, edit,… more
- Terumo Medical Corporation (Elkton, MD)
- …R&D, and manufacturing teams. f. Ensure all newly transferred products meet FDA regulations, ISO standards, GMP requirements specific to medical devices ... develops, manufactures, and markets a complete, solutions-based portfolio of high- quality medical devices used in a broad range of...equipment integration a strong plus. e. Strong knowledge of FDA regulations, ISO 13485, GMP , and risk… more
- Gilead Sciences, Inc. (Frederick, MD)
- …engineering standards, Quality by Design principles, and experience aligned with FDA , ICH, & ISPE guidelines. + Ensure all activities comply with current Good ... **Job Description** We are seeking a Director for a Facilities & Equipment Quality Oversight Support role. The role is a critical leadership role responsible for… more
- Gilead Sciences, Inc. (Frederick, MD)
- …Define and execute a comprehensive audit strategy aligned with global regulatory expectations ( FDA , EMA, MHRA, PMDA, PIC/S) and Kite's quality objectives. Ensure ... Oversight:** Oversee the planning, execution, and reporting of audits across all GMP subsystems, including Quality Systems, Production, Facilities & Equipment,… more
- Catalent Pharma Solutions (Harmans, MD)
- …tradition of quality and service. Catalent provides process development and GMP manufacturing services for Phase I/II clinical trials to industry leaders as well ... critical computer systems and laboratory documentation to support the commercial GMP manufacturing of biological drug substance and drug product. Responsibilities… more
- ThermoFisher Scientific (Frederick, MD)
- …(SOPs). + Quality and Compliance: Monitor and enforce compliance with ISO, GMP , and FDA standards. Perform visual inspections, manage batch records, and ... lbs. without assistance, Adherence to all Good Manufacturing Practices ( GMP ) Safety Standards, Cold Room/Freezers -22degreesF/-6degrees C, Fluctuating Temps… more
- The US Pharmacopeial Convention (USP) (Rockville, MD)
- …with the world's top authorities in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. USP's fundamental ... that Equity = Excellence manifests in our core value of Passion for Quality through our more than 1,300 hard-working professionals across twenty global locations to… more