- Insight Global (Murrysville, PA)
- …21 CFR Part 820 ( Quality System Regulation) and ISO 13485 (Medical devices Quality management systems ). 1. How do you ensure that CAPA activities ... Improvement 1. What role does CAPA play in continuous improvement within a quality management system ? o CAPA is integral to continuous improvement as… more
- Capgemini (Nashville, TN)
- …*Familiarity with regulatory compliance tools, such as risk management software and CAPA management systems . **Life at Capgemini** Capgemini supports all ... , or Life Sciences related areas. *4-6 years of experience in CAPA management , quality assurance, or regulatory compliance. *Strong knowledge of root… more
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- … is responsible for monitoring the effectiveness of the GxP Quality Management Systems regarding CAPA , Deviations, Investigations, and Change ... Responsibilities** + Lead continuous improvement of Quality Management Systems , such as CAPA ,... system records as required. + Monitors Quality Management Systems for trends… more
- Fujifilm (Thousand Oaks, CA)
- …of Electronic Records, Electronic Signatures, and Audit Trails. + Advanced knowledge of Quality Management System ( CAPA , deviation, change control) ... specifications. Ensure project deliverables meet business requirements + Own Quality Management System records (Deviations,... management and lifecycle + Working knowledge of quality systems and their interconnections (eg, LIMS… more
- Meta (Burlingame, CA)
- …problem-solving skills 10. Experience with Electronic Quality Management Systems (eQMS) and Corrective and Preventative Action ( CAPA ) processes 11. ... Product Quality Programs Responsibilities: 1. Implement Electronic Quality Management System (eQMS) 2....Qualifications: 13. Experience implementing and managing quality management systems (eg, eQMS, CAPA )… more
- Curia (Albuquerque, NM)
- …in the development, implementation, and continuous improvement of key quality systems , including Deviation Management , CAPA , Change Control, Supplier ... site's adherence to GMP regulations and maintaining a robust quality management system . This role...trending, and managing the CAPA and Exception Management Systems . + Owner of Quality… more
- Philips (Cambridge, MA)
- …leadership, communication, and cross-functional collaboration abilities. + You're experienced with electronic quality management systems (QMS). + You have ... The Senior Quality Manager- CAPA will play a critical...other applicable regulations. Driving continuous improvement initiatives to enhance CAPA system robustness and documentation practices. Preparing/presenting… more
- US Tech Solutions (Pittsburgh, PA)
- …Perform periodic trend analysis and corrective action effectiveness measures of all quality system events and identify opportunities for improvement **To succeed ... ** Quality Engineer - CAPA ** **Pittsburgh, PA...** Quality Engineer - CAPA ** **Pittsburgh, PA (will move to Murrysville, PA...of non-conformances - Work effectively with all levels of management to ensure CAPA action plans can… more
- Lilly (Pleasant Prairie, WI)
- …- One-QMS serves as the site lead overseeing the Quality Management System (QMS) for Central Quality Systems which enables the organization to ... + Implement and maintain the LKC Quality Management System overseeing Deviations, CAPA ,...management , problem solving; mentoring. + Previous experience with Quality management systems including TrackWise… more
- Astellas Pharma (Westborough, MA)
- …Improvement: Proactively seek opportunities for improving investigation processes, CAPA systems , and the overall quality system through innovation ... effectiveness verification, and product impact assessment. + Proficiency in electronic quality management systems (TrackWise preferred). + Working fluency… more
- Abbott (Alameda, CA)
- …generic medicines. Our 114,000 colleagues serve people in more than 160 countries. **Senior CAPA Quality Engineer** **Working at Abbott** At Abbott, you can do ... issues. + Accountable for leadership and oversight of the CAPA system , and associated deliverables. + Provide...medical device experience preferred. + Detailed knowledge of FDA Quality System Regulations (21 CFR Part 820),… more
- Hologic (San Diego, CA)
- … experience with a strong emphasis in Quality Systems , Risk Management , Root Cause Analysis and CAPA . + ASQ Certification (CQA, CQE) is preferred. ... management . + Maintains detailed knowledge of relevant quality system regulations (eg, 21 CFR Parts...understanding of quality engineering principles including risk management , nonconformance and CAPA , root cause investigation,… more
- Abbott (Columbus, OH)
- …OF ROLE The CAPA Process Analyst I: * Progresses investigations through the CAPA system in support of non- CAPA organizations. * Works closely with ... RESPONSIBILITIES * Evaluates and progress the timely completion of CAPA system activities, including effectiveness checks, raised...ISO13485 is preferred. + Able to apply strategic and quality logic and project management skills to… more
- Abbott (Livermore, CA)
- …education and experience. + 5 years of related experience. + Strong Experience with CAPA and Complaints Quality Systems **Preferred Qualifications** + 2 or ... processes remain in compliance with regulatory requirements and internal quality standards. **What You'll Work On** + Lead the...CAPA and Complaint activities. + Prepare and present CAPA reports to management and regulatory bodies… more
- Abbott (Columbus, OH)
- …products conform to established standards and agency regulations. **WHAT YOU'LL DO** + Management and development of Quality Systems Engineers. + Administer ... + Provide expert level guidance and direction of the CAPA systems Body-of-Knowledge. + Assess resource needs... records to ensure audit-readiness for internal and external quality system audits within the area. +… more
- Abbott (Sturgis, MI)
- …**WHAT YOU'LL DO** The ** CAPA Specialist** progresses investigations through the CAPA system . Works closely with other functional areas with the use ... INCLUDE:** + Evaluates and progresses the timely completion of CAPA system activities, including effectiveness checks, raised...Regulations is preferred. + Able to apply strategic and quality logic and project management skills to… more
- Abbott (Alameda, CA)
- …be responsible for implementing and progressively improving the CAPA process and electronic system within the Quality Management System at Abbott. ... issues. + Accountable for leadership and oversight of the CAPA system , and associated deliverables. + Provide...medical device experience preferred. + Detailed knowledge of FDA Quality System Regulations (21 CFR Part 820),… more
- Lilly (Carolina, PR)
- …better for people around the world. **Position Description** The Sr. Principle Associate - Quality Management System (QMS) Business Quality Assurance ... systems on behalf of the sites/areas utilizing the system IT tools. The QMS BQA is a key...of the QMS transformation program, modifying the way core quality management processes (eg, deviations, CAPA… more
- Cook Medical (Pittsburgh, PA)
- …Designated Trainer for the process to include but not limited to Investigations, CAPA Management , Event Reporting, Complaints, and Trending to ensure adequate ... biology, biotechnology, or 7 years direct, relevant experience in investigations writing, CAPA management , complaints and change control process to provide a… more
- BeiGene (Emeryville, CA)
- …overseeing and ensuring the effectiveness, compliance, and continuous improvement of the Quality Management System processes. This role involves designing, ... of related experience + 5+ years of progressive leadership experience in quality management within a regulated industry (pharmaceutical, biotechnology, or… more