- Merck & Co. (Durham, NC)
- …Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a "Safety First, Quality Always" mindset striving ... for continuous improvement. We work in the local plant connected to our global...calibration program, including implementation of new instruments for calibration, investigation into instrument events and continuous improvement by through… more
- Merck & Co. (Durham, NC)
- …calibration program, including implementation of new instruments for calibration, investigation into instrument events and continuous improvement by thorough ... SOP revisions.Participate in 8-step problem solving sessions to support investigations and develop appropriate CAPAs which lead to program improvements.Review… more
- Merck & Co. (Durham, NC)
- …vaccine capital projects Provide deep SME knowledge for manufacturing investigations support (Product and process deviations and complex material-related) ... of regulatory inspections by presenting and defending technical documentation, investigations , and change controls Evaluate and develop innovative process… more
- Merck & Co. (Rahway, NJ)
- …transfer to internal and external manufacturing sites, manufacturing investigations , process validation, second generation process development and authoring ... For commercial programs, activities include site-to-site process transfers, manufacturing investigations and trend evaluations, process enhancements, next generation process… more
- Merck & Co. (Rahway, NJ)
- …process development through process tech transfer, scale-up activities, quality investigations , change management, and authoring GMP standard operating procedures ... to leverage Decision Making and Execution Excellence skills to be successful. Off-shift (2nd) work will intermittently be expected as a part of the role to support… more
- Merck & Co. (Rahway, NJ)
- …field from an accredited college/universityRequired Experience and Skills:Relevant work experience in chemical, pharmaceutical, large molecule, or vaccine process ... seeking self-motivated individuals who are looking for an opportunity to work in a highly collaborative environment that provides substantial technical… more
- Merck & Co. (Rahway, NJ)
- …at the Rahway, New Jersey research facility. The Metrology and Validation Specialist will work as part of the integrated US Metrology and Validation team and drive a ... contribute to Standard Operating Procedures (SOP) draftingOriginate and own Investigations and Change Management recordsThe successful candidate must function both… more
- Merck & Co. (Rahway, NJ)
- …the Director may be responsible for:Evaluating pre-clinical and translational work for the purpose of generating early clinical development plan ... marketed drugsEstablishing communications with prominent clinical investigators in his/her particular field of interest, particularly those who will be willing and… more
- Merck & Co. (Durham, NC)
- …and programs.Serve as interface with local governmental EHS agencies and insurance carriers.Evaluate, with the Engineering Department, the requirements related to ... functions.Demonstrated skills in complying with one or more regulatory programs: RCRA and High-Risk Work (eg elevated work , confined space, hot work , lock… more
- AUROBINDO (Dayton, OH)
- …the strength, identity and purity of test samples and/or materials. The Chemist will work as a member of team to effectively plan and QC analytical testing using ... test procedures. The Chemist may execute 90% - 100% of their work at the bench level. Responsibilities1. Perform assigned sampling, physical, chemical tests… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …a growing operation in terms of volume/output and team size.Responsible for multiple work centers within the facility to ensure high quality and compliant product ... (right first time), schedule adherence, and productivity improvements.Support manufacturing investigations , support and manage change controls, and maintain permanent… more
- Merck & Co. (Rahway, NJ)
- …Facilitate and/or participate in Quality Notification (QN) reporting, investigations , and any related corrective action/preventive action (CAPA).- Facilitate ... aspects of clinical operations, including support/initiation and gatekeeping of work orders, placing/expediting expense purchase orders, supporting budgets, asset… more
- Merck & Co. (Rahway, NJ)
- …regulations and processes.- It is expected that this role will lead significant investigations or events directly, and mentor and coach their team to provide ... or Ph.D. in Statistics, Data Science, Engineering, or related field .Minimum of 8 years of experience in statistical analysis...California, Colorado and other US State Acts US Hybrid Work Model Effective September 5, 2023, employees in office-based… more
- Repligen (Hopkinton, IA)
- …Non-Conforming Material.Reject any non-conforming material and support Root Cause Investigations .Good organization skills and Microsoft Office software to accurately ... the quality program for customers internal and external.Maintain clean and orderly work area/ station. Comply with safety regulations and personnel policy. Other… more
- Merck & Co. (Rahway, NJ)
- …in interpreting trends from commercial process monitoring, driving further investigations and process improvements that elevate our standards.Engage Across ... dedicated to advancing the future of healthcare. You'll have the opportunity to work on an innovative and dynamic late-stage biologics portfolio, set to drive growth… more
- Merck & Co. (Durham, NC)
- …analytical, problem-solving, and communication skills. The candidate will be required to work in a fast-paced environment. Some cases may require temporary shift ... support will be required and will rotate weekly between all Site Automation team members. Work schedule is Monday through Friday 8:00 am to 5:00 pm and weekends when… more
- Merck & Co. (Rahway, NJ)
- …ensuring supporting materials remain aligned with the current system version. Work collaboratively with stakeholders in Global Labeling, System Support Team, IT ... systems within remit including: Monitor user support cases, ensuring proper investigation are conducted, CAPAs detailed and closed effectively and communication is… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …support of an expanding global manufacturing network for best-in-class CAR-T product. Work collaboratively with internal and external partners to drive global process ... and collaborate to the global change control process and global investigations .Maintain global program project portfolio and prioritize and drive projects from… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and interprets blueprints, P&IDs, and drawingsUtilize good documentation practices (GDP) for all work performed on the CMMS system work orders. Completes all ... working cooperatively with othersDemonstrated ability to effectively troubleshoot, plan work and anticipate potential problems and take appropriate actionsDemonstrated… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …alignment to Global Procedures.Act as a Site MES SME to support Quality Investigations , Corrections, and QMS records.Build the Site Readiness of MES for FDA and/or ... organization.RequirementsA minimum of a Bachelor's degree in engineering or related field or equivalent experience required. Advanced degree preferred.A minimum of 7… more
