- Legend Biotech USA, Inc. (Raritan, NJ)
- …exceptional team to manage the Quality functions ( Quality Assurance, Quality Systems, Quality Control ), including hiring, mentoring and developing ... the treatment of multiple myeloma.Legend Biotech is seeking a Senior Director of Quality Operations as part...tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.Other duties will… more
- Aequor (West Greenwich, RI)
- …to cGMP and other regulatory requirements. Key Responsibilities: Provide quality oversight for F&E, IQA Warehouse areas (including Incoming Inspections and the ... Position Overview: In this critical role, you will serve as a Plant Quality Assurance (PQA) professional, providing on-the-floor quality oversight for Facilities… more
- Eisai, Inc (Exton, PA)
- …CAPA activities. Interact cross-functionally with Upstream/Downstream Operations , Facilities, R&D, Quality Assurance, Quality Control , Validation, and other ... support commercial manufacturing. Demonstrate initiative and ownership in achieving high- quality output on time. Coordinate equipment maintenance, calibration, and… more
- Curia (Rensselaer, NY)
- Senior Quality Assurance Specialist in Rensselaer, NY Curia provides global contract research and manufacturing services to the pharmaceutical and biotechnology ... more! In this role, you will: + Assist the Quality Assurance Manager in ensuring compliance with all ...Rensselaer site. + Conduct investigations of OOS, Deviations, Change Control Management, and CAPAs + Work cross-functionally with other… more
- Merck & Co. (Rahway, NJ)
- …and global medical device and healthcare regulations, including FDA combination products cGMP , Quality System Regulation, FDA Human Factors guidance, ISO 14971, ... tactical and strategic direction on programs they lead to ensure high quality products and robust manufacturing processes.-- This position interacts extensively with… more
- BeOne Medicines (Pennington, NJ)
- **General Description:** Manages all Quality Control (QC) Physicochemistry laboratory activities to support GMP manufacturing, testing and release of materials, ... of the Physicochemistry laboratory. This position reports to the Senior Manager QC and is located full time at...(KPIs) in line with business objectives. + Expertise in Quality Control (QC) within a Good Manufacturing… more
- Merck & Co. (Rahway, NJ)
- …procedures, Training, and SOPs for all GxP automation systems.Lead integration of control systems with MES, Quality , and Batch Reporting applications.Understand ... operations, and qualification needs.Execute and develop appropriate system validation, change control , and testing documentation in partnership with project CQV and… more
- DHL Express, Inc. (Plantation, FL)
- …equipment. + Develop and implement procedures for material flow, storage, and inventory control to support production and quality requirements. + Lead continuous ... DHL today** We are seeking a highly experienced and detail-oriented Senior Material Handling Engineer to support in pharmaceutical and biotechnology manufacturing.… more
- Edgewell Personal Care (Sidney, OH)
- …time. + Travel Requirements: + Infrequent Travel. + Key Relationships: + Senior Process Engineer. + Operations, Quality , Engineering, Maintenance & Planning, ... through identification of the key critical parameters and then working to control and reduce the variation. Purpose includes leading, supporting and improving key… more
- Curia (Albuquerque, NM)
- Senior Principal Validation Engineer in Albuquerque, NM Build your future at Curia, where our work has the power to save lives. Curia is a global contract ... matching contributions + Learning platform + And more! Summary: The Senior Principal Validation Engineer oversees Validation Contractors for the Albuquerque… more
- Cipla (Hauppauge, NY)
- …Purpose: The incumbent to this role performs and oversees cGMP compliance-based services (commissioning, qualification, validation, consulting, etc.) on equipment ... that the necessary project documentation is complete, accurate and in compliance with cGMP regulations. The job duties for this position include but are not limited… more
- Cipla (Fall River, MA)
- Job Title : Quality Control (QC) Chemist FLSA Classification :...to 5 years Level 3: 5 to 10 years Senior : more than 10 years Level 2 or above is ... (may vary based on business needs) Reports To : Quality Control Manager Pay Range: $65,000 -...investigation activities. Ensure compliance to all data integrity and cGMP practices, procedures, and expect ensuring compliance with all… more
- Merck & Co. (Rahway, NJ)
- …combination product/medical device and healthcare regulations, including FDA combination products cGMP , Quality System Regulation, FDA Human Factors guidance, ... 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)
- …of DCT deliverables including - robust processes & analytics, an integrated control strategy, successful tech transfer packages, filing and approval, and a robust ... Global and regulatory requirements and execute current Good manufacturing Practices ( cGMP ) in the performance of day-to-day activities and all applicable job… more
- Integra LifeSciences (Princeton, NJ)
- …and set new standards of care. Under direct supervision of Director, Quality Reliability Microbiology, the Sr. Manager, Microbiology Reliability - Tissue Technology ... standards and regulations to medical device microbiological and sterility assurance control programs for the purposes of interpreting data, tactical planning on… more
- ICL (Lawrence, KS)
- …and balance equipment. + Operate mechanical and electrical maintenance equipment. ** Quality Control ** + Follow maintenance procedures. + Develop understanding ... of electrical and mechanical equipment. The position is a senior craftsman level job in the electrical discipline with...participate in the use of JHAs. + Comply with ISO/ cGMP /HACCP. + Comply with all Food Safety requirements as… more
- Curia (Albuquerque, NM)
- …functions such as process design, scale-up, and meticulous documentation control . This position will collaborate closely with cross-functional teams, including ... R&D, Quality Assurance, and Production, providing technical leadership and expertise...efficiency, and ensure compliance with industry standards such as cGMP and FDA regulations. Essential Duties and Responsibilities: +… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …demonstrated passion for creating new medicines.Experience with Engineering, Operations, Quality Control and Facilities Management.Experience in effectively ... Carvykti Facilities and Engineering leadership team and reports directly to the Senior Director of Facilities and Engineering. Proactive mitigation of risks as well… more
- ICL (Lawrence, KS)
- …in storeroom + Complete all job responsibilities assigned in a timely manner ** Quality Control ** + Follow maintenance procedures + Develop understanding of ... of electrical and mechanical equipment. The position is a senior craftsman level job and will involve shift work....in assigned areas keeping with ISO/AIB standards + Follow cGMP requirements for the area **General Plant Responsibilities** +… more
- BeOne Medicines (Pennington, NJ)
- …This role will be based in Hopewell, NJ and report to the Site Senior Director Facilities and Engineering. **Essential Functions of the Job:** + Strategic leadership ... delivered on time, within budget and to the required quality standards. + Process Optimization - Identify high-volume or...Allen Bradley PLC, OSISoft PI historian, Siemens, Instrumentation and control panel hardware as required by the job. +… more
