- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- Senior Quality Control Analyst Department: Chemistry Location: Monroe, NC START YOUR APPLICATION ... position is for a highly motivated member of the Quality Control (QC) Lab at the Monroe manufacturing facility,...to align with corporate guidelines. + Comply with applicable FDA and international regulatory laws/standards and the Code of… more
- Fujifilm (Holly Springs, NC)
- … Risk Management principles **Preferred Requirements:** * 10+ years' experience in a GMP quality assurance (QA) role in commercial biopharmaceutical facility * ... batches are manufactured and tested in strict compliance with Good Manufacturing Practices ( GMP ) regulations. You will maintain quality systems that align with… more
- Gilead Sciences, Inc. (Raleigh, NC)
- …expertise in SAP BRH & SAP QM module, regulatory compliance (such as GxP and FDA ), and life sciences Quality Management and Batch Release processes. As an SAP ... Adherence:** + Ensure all SAP PP/QM solutions comply with relevant regulatory requirements, including GMP , FDA 21 CFR Part 11, and other applicable standards. +… more
- Astellas Pharma (Sanford, NC)
- …of quality systems, procedures, and records to support compliant GMP operations. This position works closely with Validation, Engineering, Manufacturing, ... to instill a ' Quality Culture' by coaching in the application of GMP principles including the underlying rationale of those principles. + Author, review and… more
- Fujifilm (Holly Springs, NC)
- …* Experience in customer relationship management or alliance management * Experience in quality assurance in a GMP environment *Experience in developing and ... **Position Overview** The Sr. Program Quality Manager is responsible for programs from the...based on segments of work and regulatory requirements including FDA , EU, and other regulatory agencies * Coordinates and… more
- Merck (Durham, NC)
- …CNC Operations, Computer Literacy, Data Analysis, Digital Literacy, Equipment Maintenance, FDA Regulations, GMP Compliance, Good Manufacturing Practices ( GMP ... work in the manufacturing plants with a "Safety First, Quality Always" mindset, striving for continuous improvement, and earn...and Skills:** + At least two (2) years of GMP manufacturing/processing experience, or a Bachelor's degree in Life… more
- Reckitt (Wilson, NC)
- …improvements with engineering, maintenance, and production teams. + Maintain regulatory alignment ( GMP , FDA , ISO, EHS) and current schematics. + Execute ... in our fight to make access to the highest quality hygiene, wellness, and nourishment a right and not...compliance, and electrical codes..Strong knowledge of regulatory standards (eg, GMP , FDA , ISO 9001/13485). + PE (Professional… more
- Reckitt (Wilson, NC)
- …and integrate cutting-edge technologies for performance optimization. + Drive regulatory alignment ( GMP , FDA , ISO, EHS) across automation activities and support ... in our fight to make access to the highest quality hygiene, wellness, and nourishment a right and not...AutoCAD Electrical or EPLAN. + Experienced in regulatory compliance: GMP , FDA , ISO 9001/13485, EHS, electrical codes,… more
- ThermoFisher Scientific (Greenville, NC)
- …manufacturing site by providing administrative and operational support within the Quality Assurance (QA) department. The role focuses on driving and tracking ... systems. This position is essential for maintaining a culture of compliance with FDA , EMA, and other global health authority expectations related to GMP ,… more
- BioFire Diagnostics, LLC. (Durham, NC)
- …documents, and improves procedures and Preventative Maintenance Activities. + Adherence to FDA Regulations, GMP , ISO, HSE (OSHA), Department Procedures, and ... will also be required to work autonomously in a GMP environment in addition to being an active contributor...manufacturing line is operating at optimum level for a GMP environment in a safe manner while meeting production… more