- 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
- Repligen (Waltham, MA)
- …ISO 9001 standard.Review and approval of validation plans, deviations, failure investigations and corrective action plans prior to implementation when required. ... Design History Files for the site. Assists with OOS investigations , OOT investigations and NCMR investigations .Completes required actions for identified… more
- Aequor (Tampa, FL)
- …sampling and testing. Performs microbiology methods and sampling techniques. Performs investigations and completes CAPA in response to laboratory investigations . ... Manages change controls effectively. Manages/ supports microbiology projects from production or formulations development dept. Actively participates in customer and regulatory audits as area SME. Develops and executes validation protocols for test methods and… more
- Aequor (Houston, TX)
- …the Warehouse floor for data gathering and observing of processes for investigations o Performs other duties as assigned. Technical Knowledge Experience performing ... root-cause analysis, leading, and completing lab investigations Prior experience working in a laboratory setting required...floor for data gathering and observing of processes for investigations Willing to pursue opportunities that can lead to… 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 ... aseptic processing, equipment, and sterile technique.Experience in leading quality investigations and change management.Familiarity with United States and European… more
- Merck & Co. (Rahway, NJ)
- …Facilitate and/or participate in Quality Notification (QN) reporting, investigations , and any related corrective action/preventive action (CAPA).- Facilitate ... equipment/system changes, execute periodic reviews and support Quality Management System (QMS) activities.- Interface with site & global engineering and maintenance groups, as well as outside vendor support.-Provide facility engineering support and capital… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …first time), schedule adherence, and productivity improvements.Support manufacturing investigations , support and manage change controls, and maintain permanent ... inspection readiness and actively support regulatory inspections.Lead facility operating review meetings and sponsor various department projects to drive continuous improvements and efficiencies within cell therapy Technical Operations.Support organizational… more
- Merck & Co. (Rahway, NJ)
- …contribute to Standard Operating Procedures (SOP) draftingOriginate and own Investigations and Change Management recordsThe successful candidate must function both ... independently and be able to collaborate in a fast-paced, integrated, multidisciplinary team environment. Strong communications skills and eagerness to adapt and learn are essential attributes. As a member of our team, you will be joining scientific and… more
- Aequor (Houston, TX)
- …manufacturing floor for data gathering, observing of processes for investigations , and performance of associate interviews. Meeting Facilitation and participation, ... aligning internal review team and area subject matter experts on an agreed to investigational path forward. Complex Conflict resolution, problem solving in a cross functional setting, and ability to keep the meeting on track to achieve objectives of varying… more
- Merck & Co. (Rahway, NJ)
- …Skills:Academic Presentations, Biomedical Research, Clinical Development, Clinical Investigations , Clinical Judgment, Clinical Medicine, Clinical Research, Clinical ... Sciences, Clinical Testing, Clinical Trial Planning, Clinical Trial Support, Cross-Functional Teamwork, Data Analysis, Hematology, Intellectual Curiosity, Medical Research, Oncology, Regulatory Affairs Compliance, Regulatory Reporting, Regulatory Requirements,… 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 ... document and maintain associated paperwork and inspection results in a consistent and timely fashion.Identify and communicate continuous improvement opportunities for the quality program for customers internal and external.Maintain clean and orderly work area/… more
- Merck & Co. (Rahway, NJ)
- …Practices (cGMPs), and participating in risk assessments, deviation investigations , and Good Documentation Practices (GDPs).- Position Qualifications :Education ... Minimum Requirement: The position requires a PhD in Chemical Engineering, Bioengineering, Biological Engineering, Synthetic Biology or a related field from an accredited college/universityRequired Experience and Skills:Relevant work experience in chemical,… more
- Merck & Co. (Durham, NC)
- …Health and Safety, Executive Business Management, Incident Investigations , Industrial Hygiene, Innovation, Meteorology, Mitigated Risks, Multi-Management, ... People Leadership, Physical Sciences, Production Management, Project Management, Regulatory Compliance {+ 2 more}-Preferred Skills:Job Posting End Date:08/8/2025 *A job posting is effective until 11:59:59PM on the day BEFORE -the listed job posting end date.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …issue and handles project. This position prepares trainings, supports CAPA investigations , case review, documentation reviews in collaboration with the ICSR ... basis. Management of escalated case processing issues/troubleshooting. Supports CAPA investigations / implementation.ICSR Standards Oversight: Acts as subject matter… 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 ... on-going support.Essential Duties and Responsibilities:Lead and manage a team of subject matter experts focusing on product control strategies, statistical analysis, and advanced statistical methods, including principal component analysis, etc.Develop and… more
- Eisai, Inc (Raleigh, NC)
- …\tReviewing and making disposition decisions for manufactured product batches. \tSupporting investigations and evaluating the impact of deviations or events on ... product quality. \tActing as a Subject Matter Expert (SME) during regulatory inspections in assigned area(s) of responsibility.This role requires a high level of independence, attention to detail, and strong communication skills to foster effective… more
- Merck & Co. (Rahway, NJ)
- …in interpreting trends from commercial process monitoring, driving further investigations and process improvements that elevate our standards.Engage Across ... Functions: Actively interact with internal and external partners, representing your functional area on cross-functional teams to foster collaboration and innovation.Document Excellence: Author regulatory and technical documentation, ensuring all processes… more
- Merck & Co. (Durham, NC)
- …to ensure compliance with Good Manufacturing Practices and safety.Participates in investigations of automation incidents and problems to prevent recurrence including ... the development and implementation of corrective actions.Uses technical knowledge to assure the efficient operation of variety of automated processing and information technology systems.- Leads in installing and placing new equipment into operations.- Develops… more
- AUROBINDO (Dayton, OH)
- …laboratory instruments/equipments with supervisory direction/training.7. Perform troubleshooting and investigations under the direction of a supervisor.8. Comply ... with all regulatory/in-house requirements (may include but not limited to safety, house keeping, laboratory chemical waste, cGMP, cGLP, documentation) when performing the assigned activity.9. Review of Analytical documents as requiredQualifications - Skills &… more
