- Daiichi Sankyo, Inc. (Bernards, NJ)
- …commercial and investigational products availability in order to cover patient needs.- CAPA Management: Ensure oversight for CAPA Management activities in order ... and functions in order to ensure the deadline of CAPA plan is followed on rigor as per defined...Quality Metrics: Collecting and analyzing data related to deviations, CAPA , Change Controls, OOS, and internal/external audits performance and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma.Legend Biotech is seeking a Warehouse Operations Manager as part of the Technical Operations team based in Raritan. Role ... OverviewThe Warehouse Operations Manager will work within Technical Operations and be responsible...and on time closure of deviations, Quality investigations and CAPA 's related to operational activities.Ensure good CAPA … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …development of clinical operations related to Corrective and Preventative Action ( CAPA ) plans for issues of non-compliance if applicable. 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 required Experience Qualifications Experience Qualificaitons 4 or More… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Support regulatory inspection related activities as required such as organizing CAPA coordination teams, ensuring logistics for inspections, ensuring team list for ... QA pertinent to inspections are maintained including, training, CVs, JDs- Collect, store and maintain all auditable documentation as per DSI Internal control- Support the Head Global QA strategy and operations to develop and plan the Global QA communication… more
- Aequor (Devers, TX)
- …Field QA Specialist role is stationed in Devens, MA and reports to the Senior Manager of QA Operations for the Devens SUF. This role is Monday through Friday 2pm ... material disposition, change control, product complaints, deviations, investigations, and CAPA management. Able to effectively multi-task. Must have strong… more
- BioAgilytix (Durham, NC)
- …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 in a regulatory compliant mannerContributes to oversight of Sample Management laboratory,… more
- Novo Nordisk Inc. (WA)
- …approach, leveraging competencies, tools and technology. Relationships Reports to a Manager (or above) within NACD. Manages mutually beneficial relationships with ... stakeholders to develop and implement Corrective and Preventive Action Plans ( CAPA ) Shares information, collaborates and provides relevant input and guidance to… 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,...works cross functionally to ensure robust quality decisions and CAPA timeliness. + Facilitates Product Holds when deemed necessary… more
- Danaher Corporation (Brea, CA)
- …reimagine healthcare, one diagnosis at a time. You will be a part of the CAPA /PMS/MasterControl Team and report to the Sr. Manager of CAPA /PMS/MasterControl ... drive results. + Review and approve Quality documentation. + CAPA Coordination/Management activities. + Drive process improvements and change...verbal and Writing skills, proficient with Microsoft Office + CAPA experience It would be a plus if you… more
- Omnicell (Pittsburgh, PA)
- …Engineer II, CAPA ** The Quality Engineer II, CAPA will report to the CAPA Manager and will be responsible for leading CAPA activities from initiation ... to closure. The Quality Engineer II, CAPA , will report to the CAPA Manager and will be responsible for facilitating the CAPA program to solve complex… more
- Medtronic (Los Angeles, CA)
- …a Principal Quality Engineer, you will have responsibility for supporting the CAPA process, change control, and internal/external audit support activities for the ... and/or manage Quality Metrics. Assist with Management Review and CAPA Board meeting preparations. Function as the site key...computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions… 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...or training of users. You will report to the Manager of Quality Disposition. **How you will contribute:** +… more
- ADM (Erlanger, KY)
- **90250BR** **Job Title:** Customer CAPA Specialist - Erlanger, KY **Department/Function:** Operations: Manufacturing, Production, Maintenance, Utilities **Job ... Description:** **Customer CAPA Specialist - Erlanger,...or work at the location, please notify the hiring manager . + Domestic and global travel is expected to be… more
- Integra LifeSciences (Columbia, MD)
- …test method validations and monitoring procedures. + Change control, non-conformance and CAPA support. + Support the department manager with providing direction ... possible and making headway to help improve outcomes. This **Associate Manager , Microbiology** is directly associated with interpreting microbiological testing data,… more
- Integra LifeSciences (Cordova, TN)
- …test method validations and monitoring procedures. + Change control, non-conformance and CAPA support. + Support the department manager with providing direction ... to help improve outcomes. Responsibilities associated with this **Associate Manager , Microbiologist** are directly associated with interpreting microbiological testing… more
- Philips (Malvern, PA)
- …design history file requirements, end-of-life process, Quality Systems (eg, CFR Part 820) and CAPA management. + Act as the project manager and partner with the ... **534347 Sr. Program Manager - Product & Process Development and Remediation,...product compliance with a focus on design & development, CAPA 's, and the associated process & production controls in… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …ensure compliance and continuous improvement in a regulated environment. The investigation manager will be responsible for CAPA program management and oversight, ... + Certification in Quality Management (eg, ASQ Certified Quality Manager ) or related disciplines. + Experience with CAPA... Manager ) or related disciplines. + Experience with CAPA software systems and tools. + Knowledge of Lean… more
- LSI Solutions (Victor, NY)
- …After all, our customer is ultimately the patient. POSITION TITLE: Quality Assurance Manager LOCATION: Onsite at LSI Solutions in Victor, NY SALARY RANGE: $110,000 - ... $136,400 JOB SUMMARY: The Quality Assurance Manager is responsible for ensuring full standards compliance, leading LSI's CAPA function, implementing internal… more
- Abbott (Sylmar, CA)
- …treat people with heart arrhythmias, or irregular heartbeats. **Quality Manager ** is responsible for developing, establishing and maintaining quality assurance ... Action program for all MCS sites (five different locations). + Oversees the CAPA process from initiation to effectiveness review and ensure the CAPA … more
- Church & Dwight Co., Inc. (Old Fort, OH)
- …including: Operations, CI Lean, R&D, Compliance and Global Quality. The Quality Manager should posses the skillset to coordinate and lead all department process ... strategies with plant leadership + Ensure a cross-functional site CAPA team effectively collaborates on PQM Event (EVT) occurrences...(EVT) occurrences and meets or exceeds plant and corporate CAPA KPI + Manage and communicate on all site… more
