- 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
- Catalent Pharma Solutions (Harmans, MD)
- …Engineer - Fill Finish** **Manufacturing, Sciences, and Technology (MS&T)** to support our GMP Manufacturing Team in Harmans, MD Catalent, Inc. is a leading global ... 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… more
- Charles River Laboratories (Rockville, MD)
- …passionate about. **Job Summary** This position reports to the Site Head of Quality , and the person filling this role is responsible for partnering with functional ... stakeholders at the site level to ensure Quality performance and Compliance is designed into, and maintained, across all strategic initiatives, Operations,… 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