- Exela Pharma Sciences, LLC (Lenoir, NC)
- …six sigma. Key metrics: First Pass Yield, Scrap, number of repeat CAPAs, CAPA On Time, and Validation on Time.Job ResponsibilitiesChange Management - evaluate the ... modes, risk, and opportunities related to operational processes, and develop control plans. CAPA - lead corrective and preventive actions resulting from known issues… 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
- Aequor (Newbury Park, CA)
- …program Able to act as SME for multiple Quality processes (eg Deviations, CAPA ) Review and Approve SOPs and associated documents Review/Approve Periodic Reviews for ... GxP Systems May perform software Supplier Evaluations as needed Support project initiatives, process improvements and or projects May be required to present on topics or issues to management May support audit & Inspections requests as needed May support other… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …managing a team of at least 3 reportsKnowledge of Nonconformance and CAPA management processKnowledge of cGMP regulations and FDA/EU guidance related to ... manufacturing of cell based products as well as knowledge of Good Tissue Practices#Li-Onsite#Li-JR1Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and correctionsDevelops and performs any required remediation efforts and associated CAPA plansAuthors, 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 integrityExecutes, owns, assesses and participates in the creation, revision and review of change controls, SOPs, and… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …focus on First Pass Yield and Scrap.Completion on time for CAPA , Internal Audits, Management ReviewAudit non-conformances Perform other duties as assigned.Experience ... RequirementsStrong communicator with an ability to provide clear directions to the company.Possess a passion for results and company performance.Must set the expectation for the company in quality mindfulness and lead by example. Must be able to sit and/or… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …systems (CMMS)Quality Management knowledge, including Change control, Deviation, and CAPA 's.EHS and regulatory standards (eg EPA, OSHA and DEA)Experience with ... operating and maintaining building security equipment.Language: English#Li-BZ1#Li-OnsiteLegend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the development of relevant quality reports and outputs (JOC, QRB, QQRs, EMR). CAPA Management Support the oversight and management of QE-related CAPAs by tracking ... and following up on the status of the internal and external CAPAs to ensure adequate CAPAs are defined, implemented, and closed in a timely manner.Regulatory Inspections: Participate as a Quality Reviewer for Health Authority inspections in the US, in… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and corrections.Develops and performs any required remediation efforts and associated CAPA plans.Authors, owns and executes policies and procedures, summary reports ... and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria.Responsible for managing data integrity via software controls (Deskman, Windows, etc).Executes, owns, assesses and participates in the… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- **Job Description Summary** This position will work with cross-functional CAPA action item leader and CAPA owners. We are looking to transform our CAPA ... in helping to achieve timely and successful completion of CAPA projects across our entire Quality Management System. The...possible** with us. As a Staff Quality Engineer - CAPA , you will have responsibility for coordinating the BD… more
- Philips (Cambridge, MA)
- **Senior CAPA Engineer** **In this role you** The Senior CAPA Engineer is responsible for driving CAPA activities from issue identification to closure, ... effectively project managing all CAPA activities, ensuring the quality of CAPA record content and representing CAPAs during audits and CAPA Review Board… more
- Abbott (Alameda, CA)
- …medicines. Our 114,000 colleagues serve people in more than 160 countries. **Staff CAPA Engineer** **Working at Abbott** At Abbott, you can do work that matters, ... Opportunity** You will be responsible for implementing and progressively improving the CAPA process and electronic system within the Quality Management System at… more
- Abbott (Sturgis, MI)
- …medicines. Our 114,000 colleagues serve people in more than 160 countries. **Job Title:** CAPA Coordinator II **Working at Abbott** At Abbott, you can do work that ... of investigational tools to determine the root cause of nonconformities, ensures that CAPA plans address root causes, and that CAPAs are implemented timely to… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- **Job Description Summary** Develop and sustain quality system CAPA and processes for the Design Center that comply with applicable regulations and standards, ... Engineer, you will be responsible for planning and implementing corrective actions ( CAPA ) to address quality issues including and developing and managing quality… more
- Stryker (Weston, FL)
- …**Senior Staff Quality Engineer - NC/ CAPA ** Stryker is hiring a **Senior ... days per week. **What you will do:** + Recognized process owner for NC/ CAPA and/or other quality areas. + Work closely with sales/marketing/field personnel, and… more
- Abbott (Lake Forest, IL)
- …administration, and maintenance of a supplier quality programs such as: CAPA system oversight, Supplier Quality Management and Supplier Qualification. + Responsible ... and Supplier list maintenance. + Establish and oversee global CAPA governance. + Develop CAPA trending capabilities,...and oversee global CAPA governance. + Develop CAPA trending capabilities, enabling the identification of systemic root… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …key Quality System Elements and includes the Audit, Deviation, CAPA , Risk Management, Escalation/Serious Breach, and Quality Analytics/Data Science programs ... and internal channels. + Work closely with the R&D CAPA program, ensure timely completion of audit related CAPAs,...in conduct of audits, report generation, response review and CAPA development. + Develop and deliver training and learning… more
- Allegan County (Allegan, MI)
- …in plea negotiations. + Evaluates other APAs and provides feedback to the PA and CAPA for their use in APA performance reviews. + Supervises other APAs in completion ... the Prosecuting Attorney (PA) and Chief Assistant Prosecuting Attorney ( CAPA ) in all supervisory and administrative duties as needed...+ Acts in the absence of the PA and CAPA with limited authority as needed and assigned. Such… more
- Integra LifeSciences (Mansfield, MA)
- …to the QMS, having oversight of and ensuring compliance to the Complaint, CAPA , Audit, and Quality Planning processes, acting as the Internal Audit Manager, and ... + Assists in the initiation, processing, and completion of CAPA records in the electronic system. + Leads meetings...the electronic system. + Leads meetings and communications for CAPA updates, information, and concerns to keep CAPA… more
- BD (Becton, Dickinson and Company) (Warwick, RI)
- …Operations (adverse event reporting for pharmaceutical/medicinal products), internal audit, CAPA and management reporting activities are in compliance with the ... Operations (adverse event reporting for pharmaceutical/medicinal products), internal audit, CAPA and management reporting activities are in compliance with the… more
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