- 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
- 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
- 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
- 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
- GE HealthCare (Waukesha, WI)
- …suppliers. Lead Root Cause Investigations and Corrective and Preventive Action ( CAPA ) activities at assigned suppliers within the established procedures of the ... improvement methodologies. ASQ or AIAG Certified. Experience with PPAP, part qualification, CAPA . We expect all employees to live and breathe our behaviors: to… more
- Kasmo Global (St. Paul, MN)
- …Electrical engineering degree mandatory Keywords : Risk assessment, Labeling , TMV,Production control, CAPA , DFMEA, PFMEA, IQ/OQ/PQ, , QSR 21 CFR 820, ISO 13485, ISO ... (DFMEA) and Process Failure Mode Effect Analysis (PFMEA) Good experience in CAPA process. Measurement System Analysis / Test method Validation Test protocol and… more
- GE HealthCare (Waukesha, WI)
- …reliability plans -especially around new product designs Provide troubleshooting and CAPA expertise/assistance for unusual or persistent product problems thru the ... application of suitable L6S (Lean Six Sigma) tools & methodologies Ensure reliability testing and documentation meet all relevant internal and external standards and is consistent with guidelines for medical devices to assure regulatory compliance (FDA, IEC… more
- Abbott (Pleasanton, CA)
- …potential compliance gaps. Responsible for oversight and administration of division's CAPA system and driving effective resolutions to identified issues. Responsible ... compliance for Abbott Heart Failure organization. Oversee division's compliance lifecycle, CAPA System and External Requirements Management System. Lead division's … more
- Actalent (St. Paul, MN)
- …to handle multiple responsibilities. Experience with Corrective and Preventive Actions ( CAPA ). Additional Skills & Qualifications Preferred 2-year degree. Ability to ... work in a collaborative team-based environment. Motivation to learn and grow skill sets. Pay and Benefits The pay range for this position is $20.00 - $33.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and… more
- Bristol-Myers Squibb Company (Devens, MA)
- …BMS quality management system including but not limited to deviation and CAPA action management, interim production controls, disposition decisions, and batch record ... such as change control, product complaints, deviations, investigations, and CAPA management. Experience working in aseptic/sterile environments and/or in quality… more
- Abbott (Maple Grove, MN)
- …Familiarity with Regulatory Affairs departmental responsibilities and processes CAPA experience Windchill experience Procedural Writing Regulatory Change Assessment ... International Product Registration support Ad and Promotional Material - Regulatory Review EU and US medical device compliance Project management skills - organize and host meetings Quality System maintenance activities Documenting justification for change… more
