- W. R. Grace (Columbia, MD)
- …value creation through strategic sourcing and supplier innovation. + Ensure compliance with GMP , FDA , EMA, and other relevant regulatory standards. + Maintain ... especially in India, China, and Europe. + Strong understanding of GMP , ICH guidelines, FDA /EMA regulations, and quality systems. + Ability to assess supplier… 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 ... and equipment integration a strong plus. e. Strong knowledge of FDA regulations, ISO 13485, GMP , and risk management practices (eg, FMEA, pFMEA). f. Experience… more
- ThermoFisher Scientific (Frederick, MD)
- …procedures (SOPs). + Quality and Compliance: Monitor and enforce compliance with ISO, GMP , and FDA standards. Perform visual inspections, manage batch records, ... lbs. without assistance, Adherence to all Good Manufacturing Practices ( GMP ) Safety Standards, Cold Room/Freezers -22degreesF/-6degrees C, Fluctuating Temps… more
- Terumo Medical Corporation (Elkton, MD)
- …leading project teams is required. **Qualifications/ Background Experiences** Knowledge of GMP / FDA regulations. Ability to create and work from engineering ... drawings. Excellent communication skills both verbal and written. This position requires the ability to improve and validate manufacturing processes, and /or solve complex engineering problems. Requires strong communications skills to understand and explain… more
- Danaher Corporation (Timonium, MD)
- …Thorough understanding of ISO 9001 and AS9100 / CAA Part 145/CAA Part 21 standards. GMP , FDA knowledge and other ISO standards an advantage. + Good understanding ... of applicable regulatory requirements covering Food Contact, Product Compliance (Ce Marking, ATEX, ASME etc.), Product Environmental Compliance (ROHS/REACH) and airworthiness (CAA/FAA) The salary range for this role is 155,000 - 180,000. This is the range that… more
- ThermoFisher Scientific (Frederick, MD)
- …+ **Quality Assurance and Compliance:** Monitor and enforce compliance with ISO, GMP , and FDA standards. Perform visual inspections, manage batch records, ... lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices ( GMP ) Safety Standards, Some degree of PPE (Personal Protective Equipment) required… more
- Terumo Medical Corporation (Elkton, MD)
- …Industry 4.0 concepts, and equipment integration a strong plus. e. Strong knowledge of FDA regulations, ISO 13485, GMP , and risk management practices (eg, FMEA, ... management and preparing detailed technical reports for regulatory bodies like the FDA . c. Proven ability to lead cross-functional technical teams and mentor junior… more
- Terumo Medical Corporation (Elkton, MD)
- …and production issues. d. Ensure all automation and control systems comply with FDA regulations, ISO standards, GMP requirements specific to medical devices and ... management and preparing detailed technical reports for regulatory bodies like the FDA . 3. Problem-Solving Skills: a. Strong troubleshooting skills for equipment and… more
- Terumo Medical Corporation (Elkton, MD)
- …Requirements** **Knowledge, Skills and Abilities (KSA)** + Strong understanding of FDA regulations, ISO 13485, GMP , and other relevant quality ... and compliance standards + In-depth knowledge of process validation, equipment qualification (IQ/OQ/PQ), and software validation. + Strong familiarity with quality management systems (QMS), including change management, design controls, CAPA, risk management,… more
- BD (Becton, Dickinson and Company) (Hunt Valley, MD)
- …and doffing clean room garments. + Knowledge of the following industry regulations FDA (Food and Drug Administration), GMP (Good Manufacturing Practice) / QSR ... Manufacturing Practice) and In-depth understanding of good documentation practices in a GMP environment. + Knowledge of PC spreadsheet, word processing, and database… more