- Legend Biotech USA, Inc. (Raritan, NJ)
- …that fit the site's needs. The major responsibilities will include but are not limited to: Lead project core teams to ensure on time project delivery.Leads ... Manufacturing Science and Technology team reporting to the Manufacturing Execution Systems Lead and will be responsible for providing project management support… more
- ValSource, Inc. (Rahway, NJ)
- …ValSource is currently looking to identify experienced and technically skilled leaders with Project Lead and Project Management experience to support a ... ensuring compliance with FDA, GMP, and other regulatory requirements. ResponsibilitiesOn-Site Project Management: Interface with clients, lead teams of… more
- Merck & Co. (Durham, NC)
- …filings including technical reports and risk assessmentsAuthor or approve Change Control documentation for complex process, validation, analytical, equipment, ... and/or automation changes. Managing on-time implementation and close-out to meet project , production and supply timelines. Lead aspects of regulatory inspections… more
- Merck & Co. (Rahway, NJ)
- …on developed capabilities to ensure effective digital solution integration and adoption. Documentation and Project Management Support: The analyst will create ... Digital Transformation, Informatica Metadata Manager, Management Process, Process Flow Documentation , Project Management, Regulatory Documents, SAP Master Data… more
- Cipla (Fall River, MA)
- …is responsible for the creation and revision of new and existing GMP, project handle, qualification & validation documents preparation and execution. In this role ... team members to ensure compliance and operational success through user focused documentation at InvaGen Pharmaceuticals, Inc, Fall River, MA. The job duties for… more
- TDS Telecom (Waunakee, WI)
- …plans and determines best approach for completing fiber splicing work. Maintains all project documentation and records costs of project materials and ... to ensure adherence to TDS fiber splicing standards and ensuring accuracy and timely documentation of the final product for project closing. You will manage… more
- AdaptHealth LLC (Philadelphia, PA)
- …role in supporting audit execution while developing expertise in control evaluation, risk assessment, and regulatory compliance frameworks. Essential Functions ... Assist in developing audit plans and programs for SOX and operational audits. Lead or support execution of financial, operational, compliance, and IT audits from… more
- Merck & Co. (Rahway, NJ)
- …and develop appropriate system validation, change control , and testing documentation in partnership with project CQV and IT teams.Support establishment ... Maintenance protocols, Calibration procedures, Training, and SOPs for all GxP automation systems. Lead integration of control systems with MES, Quality, and Batch… more
- Christus Health (Euless, TX)
- …application knowledge to meet operational and organizational needs. Project implementation responsibilities include collaborating with customers contributing to ... the analysis, testing, and documentation and implementation of medium to high complexity activities...on quality assurance and testing initiatives. Demonstrates ability to lead team through complex integrated testing processes. Able to… more
- Aequor (Thousand Oaks, CA)
- …uninterrupted supply of consistent high-quality critical reagents. End-to-end ownership: Lead projects through definition, pilot, validation, SOP documentation ... banks for cell-based potency assay methods in Process Development (PD) and Quality Control (QC), with a primary focus on adherent mammalian cell lines. Support… more
- AUROBINDO (Durham, NC)
- …healthier world to live in.Job OverviewThe QC Supervisor focused on the Quality Control Laboratory, offering project and task management along with technical ... team with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In addition to several formulations under manufacture,… more
- Genscript USA Inc. (Piscataway, NJ)
- …and commissioning of MEP systems, ensuring performance verification and turnover documentation are complete. Support construction scheduling, cost control , and ... performance, safety, and compliance requirements. In addition to capital project responsibilities, the Facility Engineer will provide high-level technical oversight… more
- Cipla (Hauppauge, NY)
- …calibration, scale-up, engineering and validation studies, and assurance that the necessary project documentation is complete, accurate and in compliance with ... with internal and external stakeholders. Provide consistent, complete, and timely feedback, project status and issues, and reports to project managers and… more
- Merck & Co. (Rahway, NJ)
- …can thrive.Responsibilities include but are not limited to:Partner with functional area project teams and subject matter experts to establish and implement the ... for the microbial process team, leading the planning, implementation, and documentation of experiments for the adoption and development of innovative technologies.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Automation System (BAS) and Environmental Monitoring System (EMS)Quality Investigation / Change Control System / Documentation System (Track wise, Comet, Veeva ... are scheduled, completed, and properly documented with supporting records attached. Lead the Building and Environment monitoring team to ensure...to ensure the facility is in a state of control and update / communicate with all teams with… more
- Aequor (Vacaville, CA)
- …and regulatory inspections Works to meet schedules, timelines, deadlines Participate in and/or lead group and project teamwork; project and process ... regulations. These duties include execution of laboratory testing, trend analysis, documentation review, support of discrepancies (OOS, OOT, OOE) and other… more
- Insmed Incorporated (NJ)
- …MRC review; verify metadata, supporting documentation , and references.Ensure accurate documentation of reviewer comments, approvals, and version control in ... performance data to identify trends and opportunities for continuous improvement.Oversee quality control and audit readiness, serving as a subject matter expert on… more
- Merck & Co. (Rahway, NJ)
- …and execution, along with leadership skills to shape the technical capabilities lead a global, cross-modality technical team.The Associate Director will lead ... party logistics sites, supply chain and technology teams, and regulatory and project leaders. The successful candidate will demonstrate ownership and make informed… more
- Cipla (Fall River, MA)
- …Inspect in-process and finished product samples (where applicable) for the Quality Control (QC) Lab and follow detailed documentation procedures to deliver ... records such as temperature and humidity data calibration and PM records, Pest control records and contractor related functions. Assess online batch records in terms… more
- Eaton Corporation (Moon Township, PA)
- …and cost estimate with the project management team + Maintain project documentation control and lead lessons learned + Lead Program level ... & tracking, subcontractor/vendor requests for pricing, submittal generation/oversight, document control , and warranty support. The Project Controls Engineer… more
