- Novo Nordisk Inc. (West Lebanon, IN)
- …for the quality and oversight of the deviation investigation and CAPA (corrective actions and preventive actions) management processes. The Deviation Leader ... Assess the current state of deviation investigations and creation/assignment of CAPA . Identify recurrent deviation types and potentially ineffective CAPA … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …root cause analysis methodologies and Corrective and Preventive Action ( CAPA ) implementation. Address recurring deviations and improve investigation quality. ... teams. Ensure productivity, timeliness, and quality of investigations and CAPA implementation. Indirectly oversee Investigations Managers, providing guidance and… more
- Catalent (St. Petersburg, FL)
- …be p erforming audits, generation of audit reports and management of supplier CAPA to ensure required actions are completed within the required timeframe. The Role: ... Standards Ensure generation of audit reports, management of supplier response and CAPA . Work collaboratively with the supplier to assess and conclude acceptance of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the treatment and on time closure of deviations, Quality investigations and CAPA 's related to operational activities. Ensure good CAPA effectiveness checks ... to keep standards on day-to-day activities and avoid recurrences. Take accountability for best practices as per Legend Biotech policies and GXP requirements. Ensure compliance of operational activities with GXP, quality, training, EHS, security requirements.… more
- Aequor (Thousand Oaks, CA)
- …minor and major deviation records and lead root cause analysis sessions Own and manage CAPA and CAPA EV records, ensuring that they are implemented as intended. ... Maintain data accuracy and perform data analysis for Management reviews of the quality system on a periodic basis. Incidental travel might be required. Authority Ability to apply risk-based approach, making decisions and escalating issues appropriately Outputs… more
- Merck & Co. (Rahway, NJ)
- …reporting, and action items.Facilitate and drive building improvement projects and CAPA (Corrective Action and Preventive Action) completions.Provide input on and ... proficiently execute process setups.Provide regular feedback (both constructive and positive) to peers to promote a continuous improvement mindset.Collaborate with all building staff to share and align on best practices.Actively investigate problem statements… more
- Merck & Co. (Rahway, NJ)
- …reporting, investigations and any related corrective action/preventive action ( CAPA ).- Facilitate equipment/system change controls, execute periodic reviews and ... support Quality Management System (QMS) activities.-Provide technical expertise, troubleshooting and improved equipment reliability/performance.- Partner with cross-functional teams to implement sterile validation program. Contribute to the planning, design,… more
- Eisai, Inc (Raleigh, NC)
- …investigations into lab related deviations, discrepancies, and ensure appropriate CAPA is assigned to remediate recurrence.Responsible for talent development within ... the QC team. Accountable to develop, motivate and retain key personnel to support the product release and stability testing at US/international sites. Guide QC teams through goal setting, performance assessment, professional development, and engagement.… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …the timely processing and closure of investigations (root cause analysis), deviations and CAPA 's as directed Other duties as assigned Support and participate in site ... time expectations Smartsolve approvals in area of responsibility (CHO, DEV, CAPA , etc.) Physical Requirements 0-10% overnight travel required. The ability to… more
- Aequor (Thousand Oaks, CA)
- …work order approval, and quality approval of minor deviations and CAPA records. Responsibilities will include evaluation of compliance issues, providing ... recommendations, and assuring progress of quality records to completion. The Sr. Associate will also represent functional area for the Drug Substance Quality Assurance department in the execution of projects necessary to achieve departmental operational goals… more
- BioAgilytix (Durham, NC)
- …to prioritize receiving and accessioning Resolves discrepancies, initiating deviations, and CAPA 's, when appropriate, under the supervision of the Manager, Sample ... ManagementEnacts process improvementsEnsures data integrity and traceabilityWrites/reviews Sample Management SOPs and other associated SOPs as requiredParticipates in audits/inspections; may lead tours of sample management areaGenerates and maintains records… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …inclusion in our clinical studies- Contributes to HA response / leads CAPA activities related to diversity and inclusion Qualifications: Successful candidates will ... be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university)- Bachelor's Degree Bachelor's Degree in a relevant scientific discipline with relevant work experience… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …study teams in collaboration with CQM to ensure the timely development of CAPA responses to promote a continuous improvement of identified issues.Provide support to ... objectives, workstreams, and strategic imperatives, as needed.When needed, collaborate with CTBO, CQM, AM, and SVO to develop/provide input into metrics to help track and oversee the progress of clinical trial risks at both a study and aggregate level to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …or back-up SME, and may collaborate with team on CAPAs, including CAPA responses and approvals Project Management:Collaborates with the PSL(s) to proactively plan ... and prioritize safety surveillance and risk management activities for assigned product(s), including resource planning, oversees team's workload, anticipates potential issues and works towards resolving issues, and escalates and communicates issues, as… more
- Eisai, Inc (Nutley, NJ)
- …system audits for review of SDLC and data integrity controls. Review CAPA and verification of CAPAs of system audits. Support health authority audits/inspections ... for inspection readiness. Requirements Bachelor's degree in associated functional disciplines including IT, Data Sciences and others.Software development familiarity with both Agile and Waterfall methodology.Knowledge of coding matrix and complexity… more
- Catalent (St. Petersburg, FL)
- …Team performing audits, generation of audit reports and management of supplier CAPA to ensure required actions are completed within the required timeframe Support ... to Supplier Quality site Teams on routine queries and guidance Manage Supplier notification mailbox to ensure active management and delegation within the supplier team and associated Quality Compliance Assessments are delegated appropriately Ensure the… more
- Novo Nordisk Inc. (WA)
- …stakeholders to develop and implement Corrective and Preventive Action Plans ( CAPA ) Shares information, collaborates and provides relevant input and guidance to ... other areas within NACD, CMR, and Global partners Demonstrates technical proficiency within responsible areas, staying up-to-date on new practices, systems, and technologies while building knowledge of emerging trends and advances within area Physical… 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and corrections Develops and performs any required remediation efforts and associated CAPA plans Authors, owns and executes master and completed CQV protocols, ... summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria, specifically data integrity Executes, owns, assesses and participates in the creation, revision and review of change controls,… more
- Arthrex (Ave Maria, FL)
- …Responsible for reviewing root cause analyses, effectiveness review plans and NC/ CAPA documentation for Arthrex QMS compliance. Work with Arthrex QE's to ... improve quality and assist, where necessary, in CAPA investigations. Assist QSRC Supervisor in the training of QE's and Subject Matter Experts (SME's) on Arthrex QMS… more
