- Aequor (Pearl River, LA)
- …preparation areas of the cGMP commercial manufacturing facility. Requires good documentation skills and attention to detail. Duties will include the operation, ... and changeovers for area equipment, including biosafety cabinets, magnetic mixers, in- process testing equipment (pH / conductivity meters and osmometers). Secondary… more
- Aequor (Thousand Oaks, CA)
- …workflows, managing timelines, performing analytical review, and coordinating documentation that enables successful end-to-end clinical supply operations. This ... the background of complex supply chain activities-processing orders, updating documentation , managing version controls, and coordinating temperature excursion workflows.… more
- Cipla (Fall River, MA)
- …the next products. Training and educating employees when necessary. Recording In- process entries into respective documents. Checking the Cleanliness of machines ... all necessary equipment and instrumentation to perform activities. Maintains documentation in accordance with internal procedures and regulatory requirements(ie,… more
- Twist BioScience (South San Francisco, CA)
- …this role, you'll start by owning hands-on work across requirements gathering, documentation , and testing for high-impact system initiatives. Over time, you'll grow ... to understand both customer and stakeholder pain points.Evolving focus: Process and prioritization improvementRefine the commercial intake and prioritization … more
- Twist BioScience (South San Francisco, CA)
- …start-up environment. They will uphold standards as defined by the manufacturing process , work on continuous improvement and have good time management resulting in ... DNA quantitation, purification and cloning. Maintain thorough, accurate and detailed documentation of all work performed using existing document templates and… more
- Repligen (Waltham, MA)
- …Repligen's control environment.ResponsibilitiesKey ResponsibilitiesLead the planning, execution, and documentation of SOX IT testing activities, partnering closely ... resolution.Train and support control owners to maintain accurate, compliant SOX documentation .Evaluate the design and operating effectiveness of ITGCs across Logical… more
- Insmed Incorporated (NJ)
- …state throughout their lifecycle a plus .Familiarity with validation of documentation , audit readiness, and continuous improvement of CSV processes. Risk Management: ... Oversight: Oversee the CSV team, validation strategy and continuous process improvementEnsure compliance with GxP regulations and industry standardsFamiliarity with… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with CMR KTA teams. Manages all aspects of training materials creation and documentation to ensure vendor compliance Oversee the process of responding to ... hubs/call centers and related reimbursement support programs/services Manages the PRB process for NNI contact center programs Communicates contact center data and… more
- Merck & Co. (Rahway, NJ)
- …in Schwabenheim (near Mainz). Scope of the position is supporting the studies and documentation for the CMC part of the dossier needed to gain new registrations of ... related guidelines to pre- and post-approval CMC submissions Providing documentation to countries including creating and maintaining the corresponding documents… more
- Merck & Co. (Rahway, NJ)
- …of objectives, budget, resources, timelines, and the study protocol/related documentation .Provide overall leadership and support to the study team.Identify and ... leaders in relevant fields.Conduct quality control inspections of study protocol, study documentation files and reports.Serves as a contact and liaison with other… more
