- Aequor (Pearl River, LA)
- …the required frequency. Sampling includes environmental monitoring and utilities sampling in cGMP areas. The position is also responsible for preparing all the ... (SOPs) in routine/non-routine sampling process in areas of the cGMP manufacturing facility. Perform aseptic sampling (Environmental monitoring sampling, WFI… more
- Aequor (Pearl River, LA)
- …Substance in the media, buffer and solution preparation areas of the cGMP commercial manufacturing facility. Requires good documentation skills and attention to ... in execution and reviews of production records. Responsible for all required cGMP training including additional training assigned by their manager. Participates in… more
- Merck & Co. (Durham, NC)
- …in mechanical and technical tasks, adherence to current Good Manufacturing Practices ( cGMP ), and a commitment to environmental, health, and safety (EH&S) standards. ... basic repairs for assigned equipment;Compliance and Documentation:Takes ownership of cGMP compliance, ensuring adherence to Standard Operating Procedures (SOPs),… more
- Cipla (Fall River, MA)
- …production schedules of projects. Monitor packaging processes for adherence to cGMP , FDA, and Cipla's quality standards. Identify and resolve operational ... Operating Procedures (SOPs) as well as following current Good Packaging Practices ( cGMP ). Participate in safety related programs and or safety teams as needed.… more
- Cipla (Hauppauge, NY)
- …production, etc. to support manufacturing effectively and ensure compliance to cGMP and safety. Key Responsibilities: Accountability Cluster Major Activities / Tasks ... transfer during new product meetings Monitor the store operations for compliance to cGMP and set standards to meet the regulatory requirement and to ensure audit… more
- Cipla (Fall River, MA)
- …Procedures (SOPs) as well as following current Good Manufacturing Practices ( cGMP ), complying with legal regulations, monitoring environment. Performs other duties ... Procedures (SOPs) as well as following current Good Manufacturing Practices ( cGMP ), complying with legal regulations, monitoring environment. Must have ability to… more
- Aequor (West Greenwich, RI)
- …facilities, equipment, materials, organization, processes, procedures and products follow cGMP practices and other applicable regulations. Performs review and ... approval of cGMP processes, procedures, documents and records. Review logbooks, batch...complete, accurate, and documented according to written procedures and cGMP requirements. Alert management of quality, compliance, supply and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …personalized cell therapy to support both clinical and commercial requirements in a sterile cGMP environment. Job duties will be performed within a team based on an ... a manner consistent with safety policies, quality systems, and cGMP requirements.Build strong partnerships with Manufacturing, Warehouse, Engineering, and Quality,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment. This position is responsible for quality and maintaining the ... the cell therapy clinical manufacturing process.Support manufacturing activities for cGMP compliance through spot checks/internal audits.Collaborate with site personnel… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …performing manufacturing procedures and the execution of scheduled tasks within a CGMP environment. This position is responsible for quality and maintaining the ... commercial operation in a controlled current Good Manufacturing Practice ( cGMP ) cleanroom environment. Independently execute manufacturing or manufacturing-support processes… more
- Cipla (Reid, WI)
- …Procedures (SOPs) as well as following current Good Manufacturing Practices ( cGMP ), complying with legal regulations, monitoring the environment. Performs other ... Procedures (SOPs) as well as following current Good Manufacturing Practices ( cGMP ), complying with legal regulations, monitoring the environment. Must have ability… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …responsible for providing Commissioning, Qualification and Validation support to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual ... therapy production through safe and compliant manufacturing operations according to cGMP requirements. This role will require CQV and engineering experience, ability… more
- Cipla (Fall River, MA)
- …packaging materials; consistent with established Current Good Manufacturing Practices ( cGMP ), customer requirements and in conjunction with all Standard Operating ... and reports for accuracy Complies will all aspects of quality management system, cGMP policies, documentation and record keeping in accordance with industry and FDA… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …providing engineering support for building automation and controls systems in the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will ... production through safe and compliant manufacturing operations according to cGMP requirements. This role will require systems engineering experience, ownership… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …for performing process training activities for Operations team members who support cGMP Clinical and Commercial Cell Therapy Manufacturing. This individual will work ... in training/system applications, quality systems, or learning management systems.Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment.Ensure testing is completed in compliance with all applicable ... in a manner consistent with the safety policies, quality systems and cGMP requirements.Work in a collaborative team setting with quality counterparts that include… more
- Merck & Co. (Durham, NC)
- …Experience and Skills:Understanding of MPS methodologiesExperience with shop-floor cGMP manufacturing and related systems (ie SAP)Familiarity with pharmaceutical ... facility, equipment and/or process start up activities in a cGMP environmentDemonstrated ability to work independentlyProduction planning / scheduling… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …manner consistent with the safety policies, quality systems, and cGMP requirements.Drive continuous improvementOther duties may be assigned, as ... quality assurance, manufacturing compliance, clinical quality, or cell therapy.Knowledge of cGMP regulations and FDA/EU guidance related to GMP manufacturing of… more
- Cipla (Central Islip, NY)
- …documents Independently executes batch record review for completeness, accuracy and cGMP compliance. Support the evaluation and lot disposition of intermediates, ... all Cipla policies including safety (EHS), quality systems and cGMP requirements. Understand risks and delays to batch release...processes and how they relate to regulatory requirements and cGMP regulations with US FDA. Knowledge of SAP System… more
- Syner-G BioPharma Group (Boston, MA)
- …with subject matter experts across the organization.Ensure compliance with cGMP , regulatory, and industry standards.QUALIFICATIONS AND REQUIREMENTS: To perform this ... years of related engineering and/or technical experience required.Experience with cGMP Manufacturing within an FDA-regulated manufacturing company.Knowledge of cGxP… more
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