- BioLife Plasma Services (Annapolis, MD)
- …**PREFERRED QUALIFICATIONS:** + Associates or Bachelor's Degree + Experience working with SOPs, GDP, GMP , CLIA, and the FDA + Experience working in a highly ... regulated or high-volume retail environment + Excellent interpersonal, organizational, technical, and leadership skills \#LI-Remote **BioLife Compensation and Benefits Summary** We understand compensation is an important factor as you consider the next step in… more
- BioLife Plasma Services (Annapolis, MD)
- …tasks require prolonged glove wear **PREFERRED QUALIFICATIONS:** + Experience working with SOPs, GDP, GMP , CLIA, and the FDA + Experience working in a highly ... regulated environment **We Offer Comprehensive Benefits from Day One** + Major medical, dental, and vision insurance and prescription coverage for eligible employees + A minimum of 15 vacation days and 10 company paid holidays + Tuition reimbursement +… 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
- General Dynamics Information Technology (Fort Detrick, MD)
- …focus on ensuring products in development follow Good Manufacturing Practices (cGMPs) per FDA 21 CFR (Code of Federal Regulations). **HOW YOU WILL MAKE AN IMPACT:** ... CMC related risk of commercial partners; and perform audits and provide GMP compliance advice. + Conduct risk assessments, vendor qualifications and for-cause… more
- Catalent Pharma Solutions (Harmans, MD)
- …recognized tradition of quality and service. Catalent provides process development and GMP manufacturing services for Phase I/II clinical trials to industry leaders ... critical computer systems and laboratory documentation to support the commercial GMP manufacturing of biological drug substance and drug product. Responsibilities… more
- Guidehouse (Bethesda, MD)
- …for the laboratory's Sterility Testing Service to ensure cGMP compliance with FDA regulations. + Provide oversight of Quality Management System including document ... related to the general operation and upkeep of a GMP Quality Control laboratory, including but not limited to,...procedures and industry best practices. + Participate in the GMP training of new employees and contractors, as required.… more
- Gilead Sciences, Inc. (Frederick, MD)
- …and execute a comprehensive audit strategy aligned with global regulatory expectations ( FDA , EMA, MHRA, PMDA, PIC/S) and Kite's quality objectives. Ensure risk-based ... Oversee the planning, execution, and reporting of audits across all GMP subsystems, including Quality Systems, Production, Facilities & Equipment, Laboratory… more
- Terumo Medical Corporation (Elkton, MD)
- …easily accessible, and fully compliant with company policies, ISO 13485, and FDA regulations. + Document Review and Approval: Review, edit, and approve critical ... throughout the product lifecycle, ensuring it aligns with ISO 13485 and FDA regulatory requirements. + Compliance Monitoring: Monitor and track document revisions… more
- Charles River Laboratories (Hanover, MD)
- …in a lead or senior position. + 3 years working in a GMP environment including transacting inventory in ERP system preferred + Demonstrated attention to ... of excellence in the US and UK, we offer GMP -compliant and research-grade solutions, along with comprehensive analytical services...drugs approved by the US Food and Drug Administration ( FDA ) in the past five years. We're committed to… more
- The US Pharmacopeial Convention (USP) (Rockville, MD)
- …relating to the verification programs. + Conducts audits and/or coordinates with USP GMP auditors at USP Rockville and at USP international sites to provide ... and internationally **Additional Desired Preferences** + Extensive knowledge of FDA regulations pertaining to cGMP requirements. + Knowledge of...to cGMP requirements. + Knowledge of and experiences with GMP audits using 21 CFR parts 111 and 117… more