- Catalent (Philadelphia, PA)
- Quality Assurance Document Control Supervisor Position Summary Catalent Pharma Solutions in Philadelphia, PA is hiring a Quality Assurance Document ... committed to a Patient First culture through excellence in quality and compliance, and to the safety of every...SOPs related to batch record documentation and release.Act as lead investigator for all Problem Reports regarding batch record… more
- Merck & Co. (Durham, NC)
- …our patients. We work in the manufacturing plants with a "Safety First, Quality Always" mindset, striving for continuous improvement, and earn our right to produce. ... local plants connected to our global manufacturing network supplying the highest quality of raw materials, intermediates, and finished products.This role is within a… more
- Merck & Co. (Rahway, NJ)
- …medical device industries to set tactical and strategic direction on programs they lead to ensure high quality products and robust manufacturing processes.-- ... products and processes are developed in accordance with applicable regulatory, quality , company, and customer requirements.-This position will lead … more
- Merck & Co. (Rahway, NJ)
- …of the Research & Development division.The Associate Director, PMO People & Process Lead , is a unique role that will be heavily client-facing, accountable for ... user experience for our clients across the planning and control ecosystem.Under the broad guidance of the Executive Director,...the training forum; accountable for curating and defining a quality annual calendar of topics that achieve the purpose… more
- Eisai, Inc (Nutley, NJ)
- …incidents.Conduct annual tests and address vulnerabilities.Analyze threat data and lead hunting efforts.Deploy standards, conduct training, and track KPIs.Define ... compliance controls.Monitor and test IT compliance controls for effectiveness.Remediate control deficiencies and investigate potential unlawful actions.Oversee system data… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Ensuring compliance with industry regulations and guidelines Content Deployment: Ensure quality control of marketing content in alignment with compliance ... to experiment with us? The Position The HCP Experience Lead will play a critical role in ensuring the...planning and organizational skills with exceptionally high attention to quality of detail and proven track record of results… more
- Novo Nordisk Inc. (Boulder, CO)
- …in a manner which meets their expectations Acts in role of lead Quality Assurance for NN Boulder Change Control process, including review and disposition of ... to support analytical and process development, the CMC team works alongside Quality , Regulatory, Technical Operations and RNAi Early Development professionals at our… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking a Lead QC Microbiology Data Reviewer as part of the Quality team based in ... Raritan, New Jersey. Role Overview The Lead QC Microbiology Data Reviewer is an exempt level...relevant QC documents, logbooks, SOP's and WI's. Ensure microbiological control strategy is consistent with cGMP requirements. Participate in… more
- Merck & Co. (North Wales, PA)
- …to Senior Management of the Medical Device and Combination Product (MDCP) Quality Assurance Operations team, the Associate Director Quality Engineering & ... and other worldwide regulations and our Compa requirements.This position provides Device quality engineering and quality assurance support and leadership to… more
- Merck & Co. (Rahway, NJ)
- …and background in clinical development programs, clinical trial processes as well as quality management systems and quality control tools.Expert knowledge of ... data from clinical trials conducted worldwide. In partnership with the Clinical Quality Operations Lead (CQOL) and Head of Clinical Quality Operations, the… more
- Insmed Incorporated (Bridgewater, NJ)
- …Design Control Process for medical device products and combination products. Lead the quality assessment for product lifecycle changes, efficiency projects, ... years relevant experience requiredExtensive knowledge of cGMPs and pharmaceutical manufacturing, Quality Control and Quality Assurance.Commercial drug… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …NNUSBPI facilities as a lead auditor Works closely with Manufacturing and Quality Control to resolve open issues resulting from record reviews, internal ... to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a...compliance with specifications and procedures Releases product based on Quality Assurance record review and approval by QA Manager… more
- Tris Pharma (Monmouth Junction, NJ)
- …(CPIs)Works directly and cross functionally throughout company (ie, QA Operations, Quality Control (QC), Manufacturing, Operations, Technical Services, Senior ... Leadership, etc.) on deviations and PQC investigations relating to production operations, quality operations oversight and quality control analysis and… more
- Merck & Co. (Durham, NC)
- …written documentation of activities. Responsible for SAP transactions and change control activities including spare part lists and Preventative Maintenance (PMs) ... embraces an inclusive team culture including significant interaction with Operations, Quality , Automation, Technology, and other groups as required.The Lab Senior… more
- Merck & Co. (Rahway, NJ)
- …The Specialist - Manufacturing Automation position will report to the Director, Engineering, Automation Lead position and will be a member of the EF Team at the ... automation systems across the Rahway Site including ABB Distributed Control Systems, environmental control systems and equipment...calibrated and qualified as required.- Also, this role will lead any future changes to the system such as… more
- Merck & Co. (Rahway, NJ)
- …Senior Specialist - Manufacturing Automation position will report to the Director, Engineering, Automation Lead position and will be a member of the EF Team at the ... Organics Pilot Plant (SSO): - The SSO uses an Emerson DeltaV Distributed Control System.- The SSO is a Good Manufacturing Practice (GMP) manufacturing facility in… more
- Merck & Co. (Millsboro, DE)
- …and state regulatory requirements for animal welfare, management of controlled substances, quality control testing according to GMP standards, and emissions ... (IACUC), and facilitating communication between the Animal Services team and the Quality organization. This position will work in close coordination with other… more
- Merck & Co. (Durham, NC)
- …The site includes clean utilities, facilities equipment, manufacturing production equipment, quality labs and a warehouse. The candidate will support the ... validation testing support, supporting root cause investigations and change control activities. Actively supports, participates and embraces an inclusive team… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …stand alone during regulatory inspection through close collaboration with Operations and Quality teams Lead cross-functional investigation teams to identify root ... collecting necessary data and information associated with operational deviations. Will lead and facilitate root cause analysis investigations with site personnel and… more
- Merck & Co. (Rahway, NJ)
- …product deliverablesDevelop and implement innovative solutions to process analysis and control throughout the lifecycleAttract, lead , and develop a world-class ... maximum value to the organizationDemonstrated ability to effectively develop and lead high performing global organizations of industry leading and highly talented… more
