- Aequor (Bothell, WA)
- …both systems and processes are DI compliant through governance and risk control , and drive mitigation/remediation actions when DI gaps are identified. Periodically ... report the Data Integrity metrics of the site through the Site Quality Management Review and to the Global DI COE. Collaborate with Client Global Data Integrity Center of Excellence team to ensure adherence and alignment to Global DI policies and strategy as… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking Sr . QC Analyst (Third Shift) as part of the Quality team based in Raritan, ... NJ. Role Overview The Sr . QC Analyst, CAR-T Manufacturing is an exempt level...and/or pharmaceutical industry is required Experience in a Quality Control setting is preferred Experience with aseptic processing in… more
- Aequor (South San Francisco, CA)
- …the Clinical Biomarkers & Diagnostics (CBD) department at is seeking a highly motivated Sr data scientist to join our team and contribute to develop machine learning ... in both Python and R programming languages and associated DevOps tools (version control , Client Ops). Ability to work in a highly matrixed environment and drive… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …treatment of multiple myeloma. Legend Biotech is seeking an Operations Supervisor / Sr . Operations Supervisor (2nd shift) as part of the Technical Operations team ... work instructions, master batch records, forms, and support and manage change controls . Work closely with Operations Manager to help oversee the development of… more
- Aequor (Thousand Oaks, CA)
- …processes Own/ provide support Deviations/CAPAs, root cause assessments, and change control records Outputs Ensure product supply using a GDP compliant distribution ... model Maintain two way communication between ATO Hub and Internal and External Customers Advance on the departmental goals and key-initiatives.Basic QualificationsMaster's Degree OR Bachelor's Degree and 2 years of Life Science or Business experience… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the treatment of multiple myeloma. Legend Biotech is seeking a Master Data Governance Sr . Specialist as part of the Technical Operations team based in Raritan, NJ. ... We are actively seeking a proficient SAP Master Data Sr . Specialist with a specific focus on Materials orchestration...and analysis needs - Inclusive of development of processes, control and best business practices around data management. Build… more
- Catalent (St. Petersburg, FL)
- …aspects related to Quality Systems, Finished Product Batch Release, and Change Control .II. Basic Function: This position is responsible for managing and documenting ... Standard Operating Procedures through the periodic inspections and monitoring of process controls in all applicable areas of the manufacturing operation. The … more
- Merck & Co. (Durham, NC)
- …and patients on time, every time, across the globe. The Senior Maintenance Technician is responsible for providing equipment troubleshooting and maintenance ... and safe maintenance and repair of equipment using Hazardous Energy Control Procedures (HECPs)Compliance with current good manufacturing procedures(cGMP), safety and… more
- Insmed Incorporated (Bridgewater, NJ)
- …for the successful and timely completion of cross-functional plans. The Sr . Director of Program Management will utilize best-in-class program management support ... Development Plan and associated functional plans. As a leader, the Sr . Director of Program Management will provide cross-functional operational and program… more
- Aequor (West Greenwich, RI)
- ARI AR5 ONSITE 100% - PQA Sr . Associate (Nights)- No remote work QA Sr . Associate will be responsible for Quality On the Floor in support of Manufacturing ... needs, provides coaching, guidance and direction to Manufacturing, Quality Control and Facilities & Engineering staff in regards to...In alignment with what we have defined for FTE Sr . Associate QA role - Master's degree OR Bachelor's… more
- Merck & Co. (Rahway, NJ)
- …compliance with company requirements and regulations are delivered and sustained. The Sr CCQM Lead supports large to medium size country/cluster clinical trial ... Management (RCQM), and in collaboration with the Clinical Research Director(s), the Sr CCQM Lead establishes and/or - local clinical Quality Management System… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …access to Novo Nordisk-marketed pharmaceutical productsThe Position The purpose of the Senior CSV Analyst (Remote) position is to provide subject matter expertise in ... process improvement, and IT compliance service delivery management across the site. The Senior CSV Analyst ensures that IT solutions are implemented and released to… more
- Merck & Co. (Rahway, NJ)
- …an opportunity to be an active part of the changes in our company's business. The Senior Specialist is a key control function that ensure our supply chains are ... Job DescriptionPosition Description: Financial Supply Chain Senior Specialist The Senior Specialist is responsible for developing the company's financial supply… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …expected to complete tasks under direction and supervision of a more senior Automation Engineer. Relationships Reports to: According to the organizational chart ... implementation, start-up and troubleshooting of automation and plant floor control systems. Under close supervision is responsible for the...for the design and / or selection of instrumentation, control devices, control panels, and control… more
- Merck & Co. (Rahway, NJ)
- …lifecycle.Experience with medical device development with understanding of Design Controls (21 CFR 820.30)Familiarity with the following standards: Quality ... Management - ISO 13485, Risk Management - ISO 14971, EU MDR, Medical Electrical Equipment - EN 60601, Medical Device Software Standard - IEC 62304, ISO 11608 Needle-based injection system for medical use.Additional familiarity/experience with the following… more
- Merck & Co. (Durham, NC)
- Job DescriptionThe Quality Senior Specialist provides expertise in the coordination of resources and equipment pertaining to qualification/validation activities ... supporting the vaccine expansion facility. Primary Responsibilities: The Quality Senior Specialist will be responsible for comprehensive management of all activities… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Are you ready to maximize your potential with us? The Position The Senior Director, Enterprise Functions Insights Lead is responsible for leading the generation, ... insight-driven consultation and evidence-based strategic and tactical guidance to senior levels across the enterprise. Additionally, this role is responsible… more
- Novo Nordisk Inc. (Durham, NC)
- …technology & processes in accordance with relevant project plans & timelines. Relationships Senior Manager, Quality Control - OFP. Essential Functions Accuracy & ... Scientific Soundness of Lab Data Environmental Compliance GMP Compliance of Laboratory Maintain testing proficiency for methods Timeliness of Lab Results & Investigations Analysis of Samples Supports Deviations Follow all safety and environmental requirements… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …develops a deep and collaborative relationship with key stakeholders and senior management within Marketing, Employee Experience, Finance, Legal, IT and other ... tactics behind internal communications and engagements with customers as the senior member management Establishes relationships with external vendors and makes the… more
- Aequor (Devers, TX)
- …audits EHS program implementation Job Description: Environmental, Health, and Safety Senior Specialist (EHS Senior Specialist) Onsite role--Local candidates only ... Engineering (Maintenance and Metrology activities), Supply Chain/Warehouse, Laboratories (Quality Control and Process Development), or Cell Therapy Manufacturing. Key… more
