- IQVIA (Raleigh, NC)
- …and the function personnel in all aspects of Corrective Action Preventative Action ( CAPA ) development as a direct result of internal and/or external audits, health ... authority inspections and self-identified issues that lead to a CAPA owned by the function personnel for both in-house and outsourced trials, and in working with all… more
- GE HealthCare (Florence, SC)
- …system, and site trending to achieve Quality objectives. + Facilitates the CAPA input processes of Nonconformance, Investigations & Concessions / Deviations. + Leads ... execution of the CAPA system employing project management, lean methodologies, problem solving,...covered by standard functional practices and procedures. Activities require professional judgment, but may require more senior levels of… more
- Takeda Pharmaceuticals (Round Lake Beach, IL)
- …**Job Description** **About the role:** The Quality Associate II - Deviation and CAPA is in the Quality Systems organization at the Takeda Round Lake aseptic ... serve as the administrator for the electronic deviation and CAPA system and for the deviation and CAPA...unique skills, level of education attained, certifications or other professional licenses held, and the location in which the… more
- ADM (Erlanger, KY)
- **90250BR** **Job Title:** Customer CAPA Specialist - Erlanger, KY **Department/Function:** Operations: Manufacturing, Production, Maintenance, Utilities **Job ... Description:** **Customer CAPA Specialist -...demanding work environment and is expected to present a professional image to both external customers and internal colleagues.… more
- Terumo Medical Corporation (Elkton, MD)
- …of compliance forums such as Quality System Management Reviews, Change Board Meetings, NC/ CAPA Board meetings etc. + Promote the professional growth and ... inspection methods) are created, maintained and are effective + Manage operations-related CAPA activities in a complete and timely manner + Ensure transfers to… more
- ThermoFisher Scientific (San Jose, CA)
- …Specialist is also responsible for leading Corrective Action and Preventive Action ( CAPA ) program. This individual works directly with the cross functional CAPA ... are closed optimally and on time. They also report Customer Complaints and CAPA trending activities and metrics to management. **What will you do?** + Initiate,… more
- Abbott (Sylmar, CA)
- …Action program for all MCS sites (five different locations). + Oversees the CAPA process from initiation to effectiveness review and ensure the CAPA ... + Provide expert level guidance and direction of the CAPA systems Body-of-Knowledge. + Assess resource needs to assure...goals through coaching and mentoring. Maintains a safe and professional work environment. Complies with US Food and Drug… more
- Fresenius Medical Center (Waltham, MA)
- …and regulatory impacting measures are consistently gathered, reported, and analyzed. ** CAPA :** + Support evaluation and categorization of NC/CAPAs based on ... NC/CAPAs to involved parties and Investigation Units + Follow up of NC/ CAPA records regarding timeliness and quality/adequacy of investigation. + Support Final… more
- Hologic (Newark, DE)
- …of methods and procedures for quality assurance and systems. An experienced professional with a working knowledge and understanding of area of specialization; ... Management Review. + Provides guidance and expertise on root cause evaluation and monitors CAPA effectiveness post closure. + Performs daily reviews of the CAPA … more
- Church & Dwight Co., Inc. (Princeton, NJ)
- …and runs through June 6th, 2024, and includes exposure to leadership, professional development, networking events, and the chance to connect with students throughout ... will have the opportunity to: + Monitor Corrective and Preventive Action ( CAPA ) activities to drive timeline deliverables and ensure robust and effective… more
- CSL Behring (King Of Prussia, PA)
- …Audit Reports outlining the findings categorized according to level of risk/s and CAPA recommendations. + Approve CAPA plans resulting from audits and ... observations resulting from audits of 3rd party vendors and oversee timely CAPA resolution Identify non-compliance trends and systematic risks for assigned areas of… more
- Naval Air Systems Command (San Diego, CA)
- …causes of failures and defects, and identification of corrective and preventive actions ( CAPA ) necessary to prevent recurrence. At the GS-09 Level: Your resume must ... causes of failures and defects, and identification of corrective and preventive actions ( CAPA ) necessary to prevent recurrence. At the GS-11 Level: Your resume must… more
- Abbott (Westfield, IN)
- …be able to handle supplier audit situations and interactions in a tactful, professional and effective manner. **What You'll Work On** + Supplier Audits Develop and ... plans and associated supplier communications. + Approve and monitor Supplier CAPA plans and activities to closure including objective evidence of effectiveness.… more
- Integra LifeSciences (Cincinnati, OH)
- …and Manufacturing and including the critical quality system elements of CAPA , Complain Investigations, Control of Nonconforming Product, Product Holds and Quality ... of Quality Engineering Activities (including process validations, complaint investigations, CAPA investigations, Product hold management, design/manufacturing change support, inspection… more
- ThermoFisher Scientific (Austin, TX)
- …including master records, training, process controls, labeling, change control, and CAPA . + Monitor and measure validations, calibrations, customer feedback and ... business reviews, such as Product Complaint rates, Cost of Poor Quality, and CAPA . + Provide quality expertise to business process transfer activities, such as… more
- ThermoFisher Scientific (Millersburg, PA)
- …Collect, analyze and present site critical metric data via appropriate channels (eg CAPA Review Board, Management Review, Tier Cascade) + Track and trend process and ... to close QMS gaps and drive continuous improvement. + CAPA timeline management. + CAPA Improvement +...high levels of credibility and forge validated and positive professional relationships with subordinates, peers and upper management +… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …analysis efforts for Corrective and Preventive Actions (CAPAs) when necessary. Support CAPA investigations by R&D and Operations where field return analyses may ... assist in those CAPA investigations. Support, and provide feedback to, monthly complaint...Specific knowledge of Pyxis Dispensing Units is preferred + Professional certification is a plus; eg Six Sigma Green… more
- Teleflex (Chelmsford, MA)
- …in 5 main areas of the Quality Management System including CAPA & Nonconformance (NC) Processes; Incoming Inspection Improvements; Perpetual Audit readiness; ... are achieved and maintained. **Principal Responsibilities** * Nonconformance (NC) and CAPA processing - lead quality activities such as inspection methods, NC… more
- Takeda Pharmaceuticals (Lexington, MA)
- …schedule + Accountable to implement Safety CAPAs and quality systems such as CAPA , Change Controls and own process improvements for the department in collaboration ... Support deviation assessment, investigation root cause analysis and development of CAPA plans + Lead continuous improvement projects identified through visual… more
- Amicus Therapeutics (Marlow, OK)
- …systems for day-to-day GxP operations related to Quality Events, Investigations, CAPA , Change Management, Training, Document Management & Archival, Supplier Quality ... + Lead and direct programs for document management, GXP training, Quality Events/ CAPA , and change management. + Drive the change management program and implement… more