- Merck & Co. (Durham, NC)
- …of the Quality System Model and relationships across its componentsUnderstands quality systems relevance and importance when developing quality policies, ... and timely resolution of issuesUtilizes monitoring, performance tools and systems to ensure product quality , drive Right...working a Hybrid work consisting of three total days on- site per week, generally Tuesday, Wednesday and either Monday… more
- Merck & Co. (Rahway, NJ)
- …with the overall business goals.Drive innovation and continuous improvement in SAP systems and processes.Team ManagementBuild and lead a high-performing team of ... the EIT SAP Platform Team, the EIT SAP Technology Lead will assume the crucial role of leading all...They will ensure the smooth operation of our SAP systems with a mindset towards continuous improvement.- Their expertise… more
- Merck & Co. (Durham, NC)
- Job DescriptionThe Lead Maintenance Technician is a leader with strong interpersonal, communication, and collaboration skills responsible for leads peers in ... supporting the manufacturing process. Individual will possess the ability to lead a team, train others and contribute to and implement process improvements. The … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …for the CAR-T manufacturing site . Oversee metrics, trending, and reporting of relevant quality systems records. Implement and lead CAPA site ... of an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking Quality Systems Lead role as part of the Quality Operations team… more
- Merck & Co. (Durham, NC)
- …of our people. The Durham Team is responsible for driving MPS throughout the Durham site to enable change in the operating systems , management systems , and ... produce product in a safe manner at the highest quality , for the lowest cost, and in the shortest...Associate Director, MPS, the Senior Specialist, our Company Production Systems will lead the MPS activities within… more
- Merck & Co. (Rahway, NJ)
- …Experience supporting compliance investigations and change management. Experience working with Quality systems . Experience working in an environment with an ... degree of technical, project, and people management responsibility. - This SSO Facility Lead role within the SSO Pilot Plant leverages significant depth and breadth… 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of testing. Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements. Maintain detailed knowledge of industry ... treatment of multiple myeloma. Legend Biotech is seeking a Lead QC Microbiology Data Reviewer as part of the... QC Microbiology Data Reviewer as part of the Quality team based in Raritan, New Jersey. Role Overview… 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 & ... to support regulatory filings and audits of data, policies, procedures, and systems to ensure compliance with Medical Device (21CFR 820s) and Combination Product… more
- Merck & Co. (Durham, NC)
- …the selected individual must become proficient in the use of manufacturing systems and knowledgeable of site procedures to resolve process/equipment issues, ... minimize downtime, and ensure product quality .- This role actively supports, participates, and embraces an...and maturityEnsure on time approval of payroll activities using site approved software like ADP. Lead and support… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and LeadershipHas primary accountability for operational study-level timeline, cost, and quality deliverables. Lead the development of the clinical study plan ... of the CRO scope of work in collaboration with Outsourcing Procurement Management. Lead trial feasibility and site identification activities in collaboration with… more
- Merck & Co. (Durham, NC)
- …Engineering maintenance problems. Responsible for supporting our Manufacturing Division,- Divisional site mission by assuring quality of products and services ... ongoing facility facility/manufacturing operation and support growth initiatives at the site . Assists in and develops standard operating procedures (SOP's) and… more
- Merck & Co. (Durham, NC)
- …member of the Engineering team providing technical support to the manufacturing site . The site includes clean utilities, facilities equipment, manufacturing ... production equipment, quality labs and a warehouse. The candidate will support...as boilers, chillers, Cooling towers, air compressors, waste deactivation systems , HVAC, clean steam, WFI. Develops Standard Operating Procedures… more
- Merck & Co. (Rahway, NJ)
- …Operations (GWES) :- The Automation specialist will help to support several automation systems across the Rahway Site including ABB Distributed Control ... 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… more
- Merck & Co. (Durham, NC)
- …technology systems , and develops strategies to optimize and ensure quality and stability of automation systems through future expansion, replacement, ... and implementation of troubleshooting activities and change control. Initiate and lead collaboration within the Operations, Quality and Technical organizations… more
- Catalent (St. Petersburg, FL)
- …the Catalent St. Petersburg site . The Department has the responsibility for Quality aspects related to Quality Systems , Finished Product Batch Release, ... when production events occur as defined by SOP and lead cross functional team to classify events and deviations...status of daily work.Serve as administrator (or back-up) to quality systems as assigned (Documentum, TrackWise, ComplianceWire)… more
- Merck & Co. (Rahway, NJ)
- …technical mentorship.Experience with Potent Compound processing and containment systems (eg, isolators).Experience with Quality systemsExperience interacting ... interfacing with the automation system assets spanning production, utility systems and associated infrastructure.- Responsibilities of the Specialist -… more
- Merck & Co. (Durham, NC)
- Job DescriptionThe Engineering, Maintenance and Site Services (EMSS) organization continuously strives to improve the reliability of the Durham site operations ... and provide the best-in-class services with the final goal of delivering our high- quality vaccines to the patients around the world with our core principle of Safety… more
- Merck & Co. (Rahway, NJ)
- …with ICH/GCP and country regulations,-company policies and procedures, quality standards and adverse event reporting-requirements internally and externally.The ... of deliverables/timelines/results to meet country commitments from feasibility and site selection, recruitment, execution and close out.Accountable for performance… more
- Aequor (Seattle, WA)
- …multiple sources and conduct data verification processes to ensure accuracy and integrity. Lead quality system document review and routing. Follow up with ... products. The role will benefit from a strong understanding of working within quality document systems and managing the on-time document review cycles for a… more
