- Kelly Services (Rahway, NJ)
- …standard operating procedures and conformance to current Good Manufacturing Practices ( cGMP 's). The employee will ensure all required documentation associated with ... clinical studies and commercial reference standards in accordance with the SOP's, cGMP 's, and federal and regulatory guidelines.** + **Order chemicals and supplies,… more
- System One (Pennington, NJ)
- …Inspections: Conduct regular internal audits and inspections to ensure compliance with cGMP , FDA, and other applicable regulatory standards. + Technology Transfer & ... a plus) + Strong knowledge of Quality Management Systems (QMS), including cGMP and compliance audits + Experience leading and conducting internal lab audits… more
- Catalent Pharma Solutions (Princeton, NJ)
- …our European Center of Excellence for cell therapy in Gosselies, Belgium. The CGMP manufacturing facility is equipped with 16 flexible clean rooms, QC labs, and ... processing, cell counts, expansion, separation, and cryopreservation, in compliance with cGMP , FDA, and safety regulations. + Develop, finalize, and review… more
- J&J Family of Companies (Raritan, NJ)
- …support, technology transfer, process comparability process monitoring, change management, cGMP compliance, and advanced therapies (ie cell/gene therapy products, ... regulatory and validation requirements + Experience in a Cell/Gene Therapy cGMP manufacturing setting + Working knowledge of Lean/Continuous improvement concepts… more
- Integra LifeSciences (Princeton, NJ)
- …risk management files. + Ensure that all projects are in compliance with cGMP , cGLP, QSR (including Design Controls), ISO or other applicable requirements. **DESIRED ... using eQMS software solutions. + Knowledge of current Good Manufacturing Practices ( cGMP ) and other applicable standards. + Experience using analytical tools to… more
- Merck (Rahway, NJ)
- …substance process development. + Familiarity with concepts and application of cGMP and GDocPduring pharmaceutical development and production. + Experience withthe ... technology development PRD \#eligibleforERP \#WE25 **Required Skills:** Adaptability, Bioreactors, cGMP Regulations, Chemical Engineering, Chromatographic Techniques, Clinical Judgment, Communication,… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …Ensure products are manufactured, released and distributed in accordance to cGMP requirements and registered specifications. + Most senior professional and ... site quality operations and leadership experience, including: + Deep knowledge of cGMP requirements of local and major international authorities like EMA and US… more
- Kedplasma (Cinnaminson, NJ)
- …and maintained. Operates within the scope of EU Good Practice Guidelines and FDA cGMP 21CFR. **ESSENTIAL JOB FUNCTIONS** Every effort has been made to make your job ... operations and business processes preferred. + Knowledge of FDA, CLIA, and cGMP regulations related to plasma donation useful. + Previous experience managing profit… more
- ThermoFisher Scientific (Teterboro, NJ)
- …required. **Documentation and Compliance:** Complete and provide accurate documentation in cGMP operations. Review and close all preventive and corrective records in ... + Experience working for a metrology organization in a cGMP Biotech/Pharmaceutical manufacturing environment **Knowledge, Skills, Abilities** + Proficient computer… more
- BeOne Medicines (Pennington, NJ)
- …and product portfolio. **Essential Functions:** + Lead technology transfer for cGMP manufacturing focused drug product fill/finish. + Ensure effective information ... and output parameters. + Investigate root causes of major deviations for cGMP manufacturing, and implement CAPA for major deviations + Identifying opportunities to… more