- 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 ... a deep understanding of how our clients navigate business processes and enabling systems to deliver their job responsibilities. In this role, the candidate will… more
- Eisai, Inc (Nutley, NJ)
- …and management.Certified Information System Manager (CISM), Certified in Risk and Information Systems Control (CRISC), Certified Information Systems Auditor ... incidents.Conduct annual tests and address vulnerabilities.Analyze threat data and lead hunting efforts.Deploy standards, conduct training, and track KPIs.Define… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …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
- Tris Pharma (Monmouth Junction, NJ)
- …Jersey, Tris has an immediate opening for a Manager, Quality Management Systems (QMS). Summary:The Manager, Quality Management Systems (QMS) supports, oversees ... and Drug Administration (FDA) standards and batch record specifications.The incumbent uses systems thinking and a holistic systems -based approach to drive… more
- Merck & Co. (Durham, NC)
- …, Chilled water, Glycol, plant steam and condensate systems .Electrical distribution systems , Motor control systems , generators and ATS systems ... NC..- Must be able to read electrical prints, P&ID's and understand P&ID control loops. Extensive industrial experience involving utility systems with a strong… more
- Novo Nordisk Inc. (Boulder, CO)
- …timely fashion and in a manner which meets their expectations Acts in role of lead Quality Assurance for NN Boulder Change Control process, including review and ... Acts as SME and local Super User for NN systems , specifically for the Change Control and...support staff Demonstrate leadership skills via acting as project lead on cross-functional projects in the development and/or implementation… 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 ... projects, and the automation system assets spanning production, utility systems and associated infrastructure.- Responsibilities of the Specialist - Manufacturing… more
- Merck & Co. (Durham, NC)
- …responsible for providing cycle development and PQ for equipment and systems supporting bulk biological processes (ie Sterile Supply, Adjuvant Manufacturing, ... to advance projects goals and deliverables related to the vaccine process Lead technical studies and author documentation associated with equipment, cleaning, and… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …as site Radiation Safety Officer Alternate Site Security Officer to administer access control systems (card access, biometrics, key control ) Other duties ... applications/amendments as necessary: air emissions permit, Limited permit (neutralization systems ), Industrial Discharge permit (wastewater), Spill Prevention, Control… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …precautions and hazardous and biohazardous chemical handling.Knowledge of change control practices for major equipment, important systems , instrumentation, ... and computerized systems .Knowledge of quality systems including exception management, change control , document control .Knowledge of operating and… more
- Merck & Co. (Durham, NC)
- …System.Focus on ensuring facility and personnel remains in state of control based on Sterility Assurance requirements ensuring an integral process.- Lead ... management, strategy development, development/revision of standard operating procedures, compliance-based projects. Lead , facilitate and participate on cross-functional teams to collaboratively… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …collecting necessary data and information associated with operational deviations. Will lead and facilitate root cause analysis investigations with site personnel and ... According to the organizational chart. Essential Functions The investigation owner will lead the investigation of deviations that occur in operations and perform… more
- Insmed Incorporated (Bridgewater, NJ)
- …systems , validation principles, engineering design, and statistical process control fundamentals.Experience with providing technical authoring of CMC drug ... for being the Technical Operations liaison to the Insmed research team for lead optimization and early development programs. This position will be the dynamic… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …projects, and equipment commissioning and validation. Key Responsibilities Develop strategy and lead the implementation of systems and processes that will ... Engineering team in the successful design, construction, and commissioning of facility systems , as well as all process and laboratory equipment. Direction and… more
- Merck & Co. (Rahway, NJ)
- …manager and/or functional vendor and internal management as needed. Performs Quality control visits as required. Leads local study teams to high performance: trains ... plan for assigned studies. Ensures compliance with CTMS, eTMF and other key systems in assigned studies. Escalates as needed different challenges and issues to TA… more
- Merck & Co. (Rahway, NJ)
- …Engineer will be responsible for evaluating, recommending, implementing and supporting systems in the manufacturing and lab print environment including label and ... perform lifecycle management of bar code printers and software systems . The engineer will also look to strengthen the...a global organization.IT Service Management experience - ability to lead the delivery of services, ensuring that agreed service… more
- Merck & Co. (Rahway, NJ)
- …audits and process audits, both domestic and abroad to maintain a strong internal control environment at our company.On occasion, the incumbent will be expected to ... lead small teams of auditors audits with limited management...summaries of issues and reports which accurately describe identified control concerns, associated risks, and appropriate recommendations.Participate in-department projects… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …for selected candidate.Relationships Reports to: Director of MSAT & Quality Control Number of subordinates with direct/indirect referral: Incumbent will have mix ... map to actionable and effective CAPA that reduce recurrent deviation types Lead and supervise the deviation investigation team, assign deviations based on… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Develop positive relationship with the QA team, Quality Control , Information Technology, Maintenance, Manufacturing personnel, Technical Operations personnel, ... decisions. Independently resolves problems through the use of quality systems . Develop improvement ideas and independently implement associated solutions. Support… more
- BioAgilytix (Boston, MA)
- …LaboratoryPrepare worksheets with minimal supervisionPrepare plate mapsServe as lead analyst on sample analysis projectsTroubleshoot assaysCompile/process data (make ... to GxP guidelines)Essential Responsibilities: Data Review & DocumentationPerform Quality Control (QC) technical and scientific and compliance review of data… more
