- Aequor (Houston, TX)
- …for all Level I key accountabilities: o Responsible for the initiation, investigation and completion of Minor process deviations o Demonstrates technical writing for ... Cause Analysis (RCA) to determine the most likely cause of the deviation investigation o Familiarity with cGMP quality systems, and demonstrates ability to read and… more
- Aequor (Houston, TX)
- …The Deviation Investigator/Initiator Level III is responsible for the initiation, investigation and completion of Minor and low/medium severity Major process ... Cause Analysis (RCA) to determine the most likely cause of the deviation investigation , assessment of event for impact to Safety Identity Strength Quality Purity… more
- Merck & Co. (Durham, NC)
- …technical documents, standard operating procedures, change controls, and investigations for the performance of laboratory methodsInitiates and contributes ... to laboratory investigations as needed and follows site procedures in the documentation of Quality Notifications and Corrective/Preventative ActionsExecute test… more
- Merck & Co. (Durham, NC)
- …calibration program, including implementation of new instruments for calibration, investigation into instrument events and continuous improvement by through analysis ... and complete SOP revisions.Lead 8-step problem solving sessions to support investigations and develop appropriate CAPAs which lead to program improvements.Review and… 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
- 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
- Eisai, Inc (Raleigh, NC)
- …\tReviewing and making disposition decisions for manufactured product batches. \tSupporting investigations and evaluating the impact of deviations or events on ... record review, SOP writing, auditing, batch release functions, deviation investigation and resolution, as applicable) .Familiarity with applicable regulatory… more
- Twist BioScience (South San Francisco, CA)
- …the implementation of preventative actions identified through inspections or incident investigations .Assisting in the investigation of EH&S incidents, gathering ... information, and helping to develop initial corrective actions.What You'll Bring to the Team: Hands-on experience supporting or implementing EH&S programs, ideally within an industrial setting.Strong organizational skills with the ability to manage multiple… 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
- 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
- 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
- Aequor (Pearl River, LA)
- …deviations and CAPAs as they occur and provides information during investigations . Other duties as they are required.REQUISITE EDUCATION/SKILLS: High School degree ... with at least 2 years of work experience, or training within a cGMP manufacturing environment General knowledge of cGMP, GDP, SOP's English fluent, both written and spoken Good communication and social skills Basic understanding of the Baculovirus Expression… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …position carries out routine QC testing and may support sampling, investigations , validations, projects and other related support activities for the manufacturing ... or method verification/validation activities Participates in deviations and laboratory investigations Update standard operating procedures with help Delivers training… 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
- 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
