- BioAgilytix (Boston, MA)
- …role is ingrained within our bioanalytical technology teams, providing a variety of project support through all phases of our client services. We are currently ... seeking a Project Manager I to join our Project ...relationship and open communications with all departments, including Quality Control , Quality Assurance and Sample ManagementMaintain accurate study records… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking MES Project Manager as part of the Manufacturing Excellence team based in Raritan, ... NJ.Role OverviewThe MES Project Manager will be part of Manufacturing Science and...and fiscal awareness is preferred.Provide technical expertise of Change Control process as well as oversight of the MES… more
- ValSource, Inc. (Rahway, NJ)
- Project Manager ValSource is currently looking to identify experienced and technically skilled leaders with Project Lead and Project Management experience to ... of our regions in the US. The Commissioning, Qualification & Validation (CQV) Project Manager will interface with our clients and be responsible for preparing and… more
- Formation Bio (New York, NY)
- …to patients faster and more efficiently.About the PositionThe Director of Clinical Project Management will provide overall leadership and strategic direction for the ... clinical project management functions in a technology-driven, AI-focused biotech environment....holding external partners to high standards of quality, cost control , and on-time deliverables. Serve as the Operations Lead… more
- Aequor (Charles City, IA)
- Actual Job Title: Quality Control ScientistResponsibilities Testing of samples from manufacturing to ensure Quality and compliance according to all applicable assays ... and Procedures Providing minimum input for laboratory investigations (LIR), minimal project support Understanding of the QC software packages used during routine… more
- Merck & Co. (Rahway, NJ)
- …responsible for leading and implementing medical device and combination product design controls for both new products and inline products from early design concept ... for leading and supporting continuous improvement initiatives related to design control and risk management processes for combination products. This includes… more
- Merck & Co. (Rahway, NJ)
- …development; manufacturing process development, qualification, and validation; and design control and risk management techniques to positively support and influence ... execution against the established requirements.Represent Device Development and the project -specific Device Working Groups on cross-functional teams, including the… more
- AdaptHealth LLC (Philadelphia, PA)
- …organization. This role evaluates the adequacy and effectiveness of internal controls , risk management processes, and governance frameworks to ensure organizational ... to the enhancement of operational efficiency while strengthening internal controls and promoting effective corporate governance. The ideal candidate will… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionDigital Chemistry, Manufacturing, and Controls (dCMC) is a cross-divisional digital transformation initiative that will enable the pipeline by ... the approach of structured content management.- They will also support project management activities to ensure efficient execution and compliance within CMC… more
- Merck & Co. (Rahway, NJ)
- … Control , Mechanical Troubleshooting, Pharmaceutical Process Development, Process Control Automation, Process Optimization, Product Formulation, Project ... integrity guidelines, engineering standards, and regulatory issues.- Provides technical, project management and system leadership.-Education Minimum Requirement:-BS in Engineering… more
- Merck & Co. (Rahway, NJ)
- …operations, and qualification needs.Execute and develop appropriate system validation, change control , and testing documentation in partnership with project CQV ... is a key part of our Chemistry, Manufacturing, and Controls (CMC) hub at our site headquarters in Rahway,...and SOPs for all GxP automation systems.Lead integration of control systems with MES, Quality, and Batch Reporting applications.Understand… more
- ValSource, Inc. (Worcester, MA)
- …internal staff to act in the best interest of the client. Lead the project through an offsite design effort (at the Design partner’s location), to onsite ... timely decision making. Manage quality, schedule and cost within prescribed project limits. Ensure the thorough completion of the following process-specific… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …provide process knowledge and expertise in support of GMP investigations, change controls , document control , process improvement, process validation and data ... and updates SOPs.Owns, provides assessments and takes actions in support of change controls .Owns CAPAs and associated project plans.Supports events such as Root… more
- Genscript USA Inc. (Piscataway, NJ)
- …performance, safety, and compliance requirements. In addition to capital project responsibilities, the Facility Engineer will provide high-level technical oversight ... leadership will directly influence operational resilience, response time, and long-term cost control . This is a full-time role based onsite in Piscataway, NJ. The… more
- Aequor (Fort Worth, TX)
- …MNC investigations or CAPA assignments. Plans and carries out engineering project work with minimal direction. Troubleshoots equipment/process control systems ... Description: High-Speed Packaging experience Controls Background No specific education requirements 5-10 years of experience Engineer supporting the Engineering… more
- Insmed Incorporated (San Diego, CA)
- …efficiency of validated systems through participating in release management, change control , periodic reviews, and audit trail reviews. \tOnsite at San Diego ... simultaneously. Coordinate and lead validation activities with internal stakeholders and project team members. Author CSV Documents (Validation Plans and Summary… more
- Merck & Co. (Durham, NC)
- …Process Innovation, Process Optimization, Process Technologies, Procurement, Professional Integrity, Project Management, Risk Control Assessment, Root Cause ... Component SuppliersDevelop effective data analytics methodologies, including statistical process control , deepening process understandingAuthor, review, and/or edit technical documents… more
- Cipla (Hauppauge, NY)
- …Hours/ Shift/ Remote General Shift (8:30a - 5:00p) Job Summary Monitor and control the production demand for raw material, packing material and finished goods by ... handling ie by following all procedure strictly Collate and prepare change controls , deviations, qualifications and validations studies documents as per cGMP Ensure… 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
- Insmed Incorporated (NJ)
- …management and remain in a validated state (eg SDLC, IT Change Control ) per associated SOPs, regulatory and security requirements. \tEnsure compliance and ... efficiency of validated systems through participating in release management, change control , periodic reviews, and audit trail reviews.What You'll Do: Develop… more
