- Catalent Pharma Solutions (Harmans, MD)
- …Management, Goal Setting and Managing through Conflict. + Proficient knowledge of GMP 's, FDA regulations and documentation procedures required + Performance ... continuous improvement initiatives. The Document Control function supports both the GMP and development operations. Catalent, Inc. is a leading global contract… more
- ThermoFisher Scientific (Frederick, MD)
- …Thermo Fisher Scientific training requirements on time and operate within all ISO, GMP , and FDA standards pertaining to Frederick Site Manufacturing Operations. ... 40 lbs. without assistance, Adherence to all Good Manufacturing Practices ( GMP ) Safety Standards, Laboratory Setting, No contact lens allowed; prescriptive glasses… 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
- 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
- BioLife Plasma Services (Annapolis, MD)
- …tasks require prolonged glove wear **Preferred Qualifications** + Familiarity with SOPs, GDP, GMP , CLIA, and FDA regulations + Experience working in a regulated ... industry or high-compliance 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… 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
- 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