- Aequor (Houston, TX)
- …of Supply Chain Quality Records (such as deviations, material recalls, and CAPA ) in partnership with applicable SMEs. Leads error prevention and continuous ... members to communicate investigational current status, alignment meetings, facilitated reviews, CAPA discussions, comments resolution. o Works well on a team, and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with robust root cause analysis utilizing Standard Problem Solving (SPS) methods and strong CAPA development within the NN deviation IT platform Serve as chair of PV ... Specific or technical job skills Strong Root Cause Analysis and CAPA development skills. PV experience/knowledge preferred Excellent interpersonal skills and ability… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …processing issue and handles project. This position prepares trainings, supports CAPA investigations, case review, documentation reviews in collaboration with the ... as-needed basis. Management of escalated case processing issues/troubleshooting. Supports CAPA investigations / implementation.ICSR Standards Oversight: Acts as subject… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …as the business process owner for the Corrective and Preventive Actions ( CAPA ) process and is responsible for ensuring compliance within quality systems ... processes.Key Responsibilities Provide oversight to the CAPA program for the CAR-T manufacturing site.Oversee metrics, trending, and reporting of relevant quality… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …ensuring the execution of a risk-based audit program and effective CAPA management resulting from audits, health authority inspections across the organization ... and that evidence is archived.Ensure up to date audit CAPA information in the eQMS in a timely manner.Support... information in the eQMS in a timely manner.Support CAPA completion for all outsourced audits with Development and… more
- Merck & Co. (Rahway, NJ)
- …Business Processes, Business Process Management (BPM), Business Support, CAPA Management, Clinical Supply Chain Management, Clinical Testing, Communications ... Support, Customer Experience Optimization, Customer-Focused, Databricks Unified Data Analytics Platform, Driving Continuous Improvement, Enterprise Systems, Financial Accounting Controls, Financial Operations, GitHub, Human Resources (HR) Shared Services… more
- Merck & Co. (Rahway, NJ)
- …energy efficiency, and compliance.Lead root cause analysis and corrective/preventive actions ( CAPA ) related to HVAC system failures or deviations.Monitor and ensure ... environmental compliance, HVAC system operational reliability, coordination of maintenance programs, system efficiency/cost performance, energy optimization and provide technical support to partners, facility owners and engineering project/capital teams.Manage… more
- Merck & Co. (Durham, NC)
- …troubleshooting using the Problem Solving Application (PSA) tool.Support CAPA implementation.Liaison between Mechanical Service Engineer (MSE) and Operations.Review ... work order documentation.Accountable for work order proper handling.Train other mechanics on shift.Participate of Safety Walkthroughs and GEMBAs.Additional Responsibilities:Must be flexible to perform all of the following functions and other tasks as… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Mitigation programs to ensure compliance to regulatory guidelinesEnsure up to date audit CAPA information in the eQMS in a timely manner. Collaborate with QMS Team ... and applicable QA function to ensure no overdue CAPAs.Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education:Must have a BS degree in a scientific discipline. Experience… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …coordinate, and manage root cause analysis, corrective action(s)/preventative action(s) ( CAPA ) in connection with audit and/or inspection responses, and ensure ... proper implementation across various areas of the business Demonstrate leadership skills via acting as project lead on cross-functional projects in the development and/or implementation of processes and programs Maintains current understanding of laws and… more
- Merck & Co. (Rahway, NJ)
- …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 project administration (processing capital requests and… more
- Aequor (Houston, TX)
- …to communicate investigational current status, Alignment meetings, facilitated reviews, CAPA discussions, Comments resolution. Work on the 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… more
- Aequor (Tampa, FL)
- …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 equipment qualification.… more
- AUROBINDO (Durham, NC)
- …entries in ERP system related to the department.To write the deviations and CAPA for the departmental activities.Perform any and all additional tasks relating to the ... ware house department as requested.Follow company policies, cGMP's, safety and Standard Operating Procedures. Qualifications - Skills & RequirementsAbility to follow written instructions precisely and perform basic math calculation.Understanding/knowledge of… more
- Repligen (Waltham, MA)
- …but not limited to Internal and External Auditing, Nonconforming Materials, CAPA , Validation, Change Controls, and other product life cycle management ... activities.Partner with cross-functional stakeholders for continuous improvement activities; create and revise procedures, practices, and specifications; provide training on quality system and procedures.Maintain strong cross-functional quality focus; build,… more
- Twist BioScience (South San Francisco, CA)
- …Manufacturing environment and follow the lean manufacturing concepts.Training in CAPA , HAZMAT, Chemical Hazards, Forklift, and SafetyAbout Twist BioscienceTwist ... Bioscience synthesizes genes from scratch, known as "writing" DNA. Just as children learn to both read and write, the next phase of development for the genomics revolution is the ability to write DNA.At Twist Bioscience, we work in service of people who are… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …years with experience coordinating and managing regulatory audits and inspections, incl. CAPA management (Prefered). Travel: Ability to travel up to 10% Business ... travelDaiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability,… more
- Church & Dwight Co., Inc. (Princeton, NJ)
- …Summary Reporting to the Global QMS Head (change control, document control/training, CAPA , validation), the Global Quality Area Head is responsible for leading the ... development and implementation of a technical QMS area CAPA ) of Church & Dwight's global Quality Management System...conversations with IT to drive system enhancements to enhance CAPA performance and compliance. This position is responsible for… more
- Caris Life Sciences (Phoenix, AZ)
- …Summary** As part the Quality Assurance team at Caris Life Sciences, the Manager, CAPA & Complaints position provides quality oversight of the CAPA and ... and timeliness along with the review and approval of CAPA changes and extension requests. + Responsible to for...and standards. + Apply Risk Management standards to all CAPA system and Complaints processes. + Work with other… more
- Fresenius Medical Center (Waltham, MA)
- **PURPOSE AND SCOPE:** The CAPA Quality Engineers are assigned Corrective Action and Preventive Action ( CAPA ) investigations as well as Non-Conformance (NC) ... NCs. **PRINCIPAL DUTIES AND RESPONSIBILITIES:** + Utilizes Quality System to ensure CAPA system is successful and compliant. Partners with Quality Systems personnel… more
