- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Director of GMP Compliance will be a part of the Compliance Support and Remediation team within our company's Global Quality Compliance ... Health operating units and requires extensive collaboration with manufacturing sites and global GMP SMEs.-Job Function:serve as a subject matter expert for good… more
- Aequor (San Diego, CA)
- …systems o SCADA systems o analytical and process equipment computers Ensure compliance with industrial standards and GMP guidelines Apply technical solutions ... Expert Engineer - Automation/OT Hybrid San Diego site...and process equipment computers for Gene Therapy operations. Ensure compliance with industry standards and GxP guidelines. Execute project… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …cell therapy to support both clinical and commercial requirements in a sterile GMP environment. This role includes supervision of QA shop floor personnel as well ... personnel, Product Development, andQuality/Manufacturing personnel.Independently makes appropriate and compliant GMP decisions.Independently resolves problems through the use of quality… more
- Merck & Co. (Durham, NC)
- …is given to issues as they arise Serve as a Subject Matter Expert during tours to provide area/process overview information to visitors/auditors upon request - ... (PLC), robotics) Maintenance Equipment (eg tools and calibration equipment) - Compliance : Ensure that maintenance activities are executed in compliance … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …safety needs Product Quality: Oversees the implementation of procedures to ensure compliance with Good Manufacturing Practice ( GMP ) with respect to technical ... responsible person, the head of Patient Safety will act as the safety expert to establish and maintain processes, procedures and controls to ensure compliance… more
- Aequor (Swiftwater, MN)
- …to achieve submissions and approvals in key markets and to maintain regulatory compliance for License registrations in existing markets. The position is based in ... Mission The Regulatory CMC Specialist in Regulatory Site Office supports regulatory compliance for marketed products by means of compliant and timely handling of… more
- Merck & Co. (Rahway, NJ)
- …drug product design from the bench top to the Good Manufacturing Practice ( GMP ) manufacturing facilities, our Scientists use cutting edge science to transform drug ... of novel drug delivery technologiesIs a recognized subject matter expert in at least one area of drug delivery...applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los… more
- Merck & Co. (Durham, NC)
- …are not limited to; Project Support Supports project team as operations expert through start-up, commissioning, qualification through licensure and ramp up of ... to support project and future operations. Identifies and addresses compliance , environmental, safety, and process deviations as appropriate while coordinating… more
- Merck & Co. (Durham, NC)
- …but are not limited to:Project SupportSupports project team as operations expert through start-up, commissioning, qualification through licensure and ramp up of ... documents) to support project and future operations.Identifies and addresses compliance , environmental, safety, and process deviations as appropriate while… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …Provides direct leadership to HEPA certification technicians Acts as Subject Matter Expert (SME) for HEPA certification sitewide needs Provides support to cross ... executing training as required Lead, develop, and support measurement methods in compliance with regulations (ISO 14644, EU Annex 1) Administration of HEPA testing… more
