- 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
- 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
- Experis (Gretna, LA)
- Our client, a leader in the medical device industry, is seeking a CAPA Process Analyst II to join their team. As a CAPA Process Analyst II, you will be part of ... and a collaborative mindset which will align successfully in the organization. Job Title: CAPA Process Analyst II Location: Gretna, LA Pay Range: $30 - $33/hr on w2… 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
- Actalent (Minneapolis, MN)
- …Supplier Corrective Action Requests (SCAR). Implement Corrective Action and Preventive Action ( CAPA ). Monitor Cost Of Poor Quality (COPQ). Participate as a member of ... Analysis. Additional Skills & Qualifications Bachelor's degree. Experience with SCAR, CAPA , CpK, PPAP, Control plan, Non Conformance, and Audit. Ability to… more
- Mindlance (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… more
- Kaiser Permanente (Arlington, VA)
- …MD RN License, DC License within 6 months. ACLS and PALs. CAPA /CPAN Preferred. Recent ASC or Inpatient PACU experience. Primary Location: Virginia,McLean,Tyson's ... Corner Medical Center Scheduled Weekly Hours: 40 Shift: Variable Workdays: Mon, Tue, Wed, Thu, Fri, Sat Working Hours Start: 12:01 AM Working Hours End: 11:59 PM Job Schedule: Full-time Job Type: Standard Worker Location: Onsite Employee Status: Regular… more
- BioSpace (New York, NY)
- …and review respective reports related to site issues and contribute to CRO CAPA development, as required. Review and contribute to CO sections of Clinical Study ... Reports (CSRs) in collaboration with Clinical Science team. Ensure sites' Investigator Site Files (ISF) are inspection ready in collaboration with the CRO and internal stakeholders. Track site enrollment, monitoring visit progress, and site issue(s) follow-up… more
- Coherent Corp. (East Granby, CT)
- …Identify opportunities for yield improvement, cost reduction, and automation. Support CAPA , root cause analysis, and process optimization initiatives. Up to 30% ... international travel is expected, subject to change based on business needs Qualifications Required: BS or MS in Engineering (eg, Optical, Mechanical, Biomedical, or Manufacturing). 3+ years of hands-on engineering experience in optical fiber processing,… more
- The Fresh Factory (Carol Stream, IL)
- …GMP adherence Preform Process Reviews Be a front line investigator for Quality Complaints, CAPA / Internal Audit Program Be the Operations to QA liaison for all ... issues Backfill QA coverage as needed As needed, be the senior representative for operations in the absence of the line leads Other duties as needed related to the development and execution of the Quality Control System Qualifications: Strong communication… more
- IMI Plc - Legacy Precision (Minneapolis, MN)
- …for the site. Lead the site Corrective Action and Preventative Action ( CAPA ) process. Drive visual management into all aspects of the manufacturing environment ... (R&R), trend analysis, 8D, etc.) Experience with Corrective and Preventive Action ( CAPA ) and failure investigation tools and techniques. Ability to identify problems… more
