- 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 (Thousand Oaks, CA)
- …Under general supervision, this position will perform routine procedures (ie, NC/ CAPA /CC) and process improvements projects to support Corporate Quality Control. ... maintenance of Corp QC training portfolio, training records, multisite procedures, CAPA /Change control records, written procedures and general support to Corporate… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …systems with the ability to manage Change Controls Support deviation and CAPA investigations and corrective actions Support of Health Authority inspections Support ... area equipment validations in accordance with procedures requiring some direction Possesses technical and systems knowledge and is able to research information outside of knowledge base Has ability to recognize problems and recommend solutions to problems… more
- Aequor (Swiftwater, MN)
- …and preventive maintenance Assist in completion of change controls, deviations, CAPA 's to support timelines Author cGMP documentation including protocols, reports, ... procedures, and user requirement specifications Assist in implementing new technologies to improve QC testing efficiency and capabilities Support QC laboratory inspection readiness Develop an understanding of best practices for optimal equipment operation and… more
- Merck & Co. (Durham, NC)
- …1 more}-Preferred Skills:Condition-Based Maintenance, Corrective and Preventive Action ( CAPA ), Lean Six Sigma (LSS), Manufacturing, Planned Maintenance, Predictive ... Maintenance, Problem Solving, Reliability Centered Maintenance (RCM), Six Sigma, Standard Operating Procedure (SOP), Written CommunicationJob Posting End Date:06/20/2025 *A job posting is effective until 11:59:59PM on the day BEFORE -the listed job posting end… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …MA business functions on the creation of Corrective and Preventive Actions ( CAPA ) to ensure compliance and improve data quality. Compliance and Quality OversightPlay ... a key role in ensuring compliance with regulatory requirements while driving innovative quality solutions.Collaborate with Global QMS eCompliance team to drive harmonization of systems specific to RD, PV, and Medical Affairs.Oversee and ensure the deliverables… 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
- 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
- Novo Nordisk Inc. (West Lebanon, IN)
- …supervisor Support resolution of quality system items (quality notes, deviations and CAPA ) as requested Must be self-driven and able to prioritize, problem-solve and ... trouble shoot in a fast paced, complex environment Execute all CMMS work in strict compliance with governing procedures and policies. A high level of attention to detail is required Communicate effectively with all internal and external customers. Must have a… more
- Beckman Coulter Diagnostics (Miami, FL)
- …expertise in quality systems and tools, including risk management, CAPA , APQP, PPAP, FAI, and statistical analysis methodologies.Exceptional communication and ... interpersonal skills, with a proven ability to influence cross-functional teams and external suppliers.Ability and willingness to travel up to 25%, based on business needs.It would be a plus if you also possess:Experience working in FDA-regulated industries or… more
- Aldevron (Miami, FL)
- …to Root Cause identification and Corrective Actions and Preventative Actions ( CAPA ).Develop and execute data collection plans, interpret data, draft protocols and ... study reports, engage in customer interactions in support of test method validation activities.Act as a technical SME and assist in developing and training Analytical Method Validation Associates in more complex analytical technologies.The essential… more
- Fresenius Medical Center (Waltham, MA)
- **PURPOSE AND SCOPE:** The Senior Engineer, CAPA is responsible for coaching CAPA Engineers to ensure CAPAs (corrective and preventive action) and ... DUTIES AND RESPONSIBILITIES:** + Utilizes Quality System to ensure CAPA system is successful and compliant. Partners with Quality...+ Responsible for assigned CAPAs and will act as CAPA lead to CAPA Owner/Team providing project… 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
- Catalent Pharma Solutions (Harmans, MD)
- **Specialist, III CAPA ** **Summary:** _Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, ... products that help people live better, healthier lives. The ** CAPA Specialist III** is responsible for supporting the ...CAPA Specialist III** is responsible for supporting the CAPA process by assisting in the initiation, tracking, trending,… more
- Catalent Pharma Solutions (Harmans, MD)
- **Senior Manager, CAPA ** **Summary:** _Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, ... live better, healthier lives. The primary responsibilities of the **Senior Manager, CAPA ** include managing the Corrective and Preventive Action ( CAPA ) system,… more
- Hologic (San Diego, CA)
- CAPA Process Lead San Diego, CA, United States...healthier lives everywhere, every day. We are hiring a CAPA Process Lead in our Diagnostics division here in ... our QA function, you will actively drive Corrective and Preventive Actions ( CAPA ), from issue identification to implementation of solutions, and verification of… more
- Abbott (Sturgis, MI)
- …working mothers, female executives, and scientists. **WHAT YOU'LL WORK ON** The CAPA Specialist: + Progresses investigations through the CAPA system in ... investigational tools, to determine the root cause of any nonconformity, ensure that CAPA plans address root causes, and ensure that CA/PAs are implemented to… more
- Abbott (Sturgis, MI)
- …www.abbottbenefits.com (http://www.abbottbenefits.com/pages/candidate.aspx) **WHAT YOU'LL DO** The ** CAPA Specialist** progresses investigations through the ... tools to determine the root cause of any nonconformity, ensures that CAPA plans address root causes, and ensures that corrective actions and preventative… more
- Abbott (Alameda, CA)
- …medicines. Our 114,000 colleagues serve people in more than 160 countries. **Senior CAPA Quality Engineer** **Working at Abbott** At Abbott, you can do work that ... to be onsite Mon-Fri. The position will be responsible for driving CAPA projects through its entire life cycle, mentor lower-level engineers, while strategizing… more
- Hologic (Marlborough, MA)
- Global CAPA & Compliance Manager Marlborough, MA, United States Are you an experienced Quality leader with a passion for compliance and driving impactful change? ... Hologic is seeking a Global CAPA and Compliance Manager to oversee and ensure a robust and compliant CAPA and Nonconforming process. This role is also pivotal in… more
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