- Novo Nordisk Inc. (Plainsboro, NJ)
- …close collaboration with the Legal Department, IT, HR, Ethics & Compliance, and records management stakeholders, and all other relevant functional areas. The ... realize your potential? The Position The head of eDiscovery and Legal Data Management will drive the development, implementation, operation, and management of… more
- Aequor (Seattle, WA)
- …technical trouble shooting skills - ServiceNow experience preferred - Excellent time management and attention to detail - Experience in the same/similar regulated ... industry Position Summary: The Learning Management System (LMS) Administrator will manage and coordinate training...to users via the LMS File and maintain training records for easy retrieval. Partner with the inspection/audit subject… more
- Aequor (Thousand Oaks, CA)
- …areas Assure timely and fully compliant (RFT) maintenance of Change Control Management system related to Global Distribution Change Records (GDCR) and/or ... execution of the implementation plan in terms of project management and change control execution. This role will apply...and change control execution. This role will apply project management and operational excellence to support the execution of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Role Overview The Associate Director for Operations Compliance and Investigations Management will provide strategic direction and leadership for the investigations ... management system. Working closely with the Quality Senior Manager,...KPIs related to investigation quality, timeliness, closure rates, overdue records , and deviations recurrence, and take proactive measures to… more
- Novo Nordisk Inc. (Atlanta, GA)
- …scientific integrity; regulatory and process compliance) for monitoring and site management activities. Takes ownership to deliver upon near-term North America ... planning for assigned clinical trial sites, leveraging Risk Based Quality Management (RBQM) principles and tools; executes activities relevant to all visit… more
- Aequor (Louisville, KY)
- …development and maintains departmental SOPs and other controlled documents on transportation management Owns quality records related to TSP activities - ... Deviations/Corrective Actions Manages other projects as assignedBasic Qualifications- Bachelor's degree OR Associate's degree and 4 years of experience OR High school diploma / GED and 6 years of experience more
- BioAgilytix (Boston, MA)
- …hear from you!Essential ResponsibilitiesParticipates in the monitoring of the Quality Management Systems (QMS), including, but not limited to, Vendor Program, ... and internal), by facilitating scheduling and staff coordination, accessing records , addressing inspection/audit requests, and performing other tasks, as… more
- Catalent (Philadelphia, PA)
- …Control individual is responsible in preparing customer files, review and approve batch records , and release batch records and finished product. The Quality ... Document Control manages the communication between the operations/production, project management , shipping and quality assurance groups to ascertain pertinent… more
- BioAgilytix (Durham, NC)
- …the patients who need them.The Archive Manager is responsible for the management , operation, and procedures related to archiving in accordance with BioAgilytix ... and relevant GxP regulations. Their responsibilities encompass the strategic management , efficient operation, and meticulous procedural oversight of the archival… more
- Catalent (San Diego, CA)
- …The Role:Lead the development of site Quality Objectives, site Quality Plans, Quality Management Reviews, etc. and oversee and execute all Performance Management ... complaints. Review and approve GMP documentation, including SOPs, Manufacturing Batch Records , validation protocols and reports, and executed Batch Records … more
- Aequor (West Chester, PA)
- …(All States as revealed per SSN Trace) 7-Year Nationwide Criminal Records Search (NCRS) 7-Year Federal Criminal District Criminal Search International Criminal ... not limited to the below checks: o General Services Administraction System for Award Management (SAM) o Office of the Inspector General (OIG) o US Department of… more
- Aequor (Devers, TX)
- …fashion. Recognizes and reports safety, maintenance and operational variances to area management . Communicates status of operations to area management in a ... timely manner. Follows detailed SOP's and batch records . Ensures compliance with cGMP and safety requirements. Maintains files, records and equipment. Records… more
- Novo Nordisk Inc. (Pittsburgh, PA)
- …support activities in region to Director including budget expenditures as directed Records all activities within a customer response management system (eg ... policies, legal, regulatory, and compliance requirements Ensures effective administrative management of regional business as well as operational budgets Maintains… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …cell, and CAR-T process) according to standard operating procedures and batch records and ensure safe and compliant manufacturing operations according to cGMP ... create/revise operational procedures, including manufacturing work instructions, master batch records , forms, and support and manage change controls. Work closely… more
- Novo Nordisk Inc. (Durham, NC)
- …matters. The Position Performs quality review & approval of Batch Production Records (BPRs), Change Requests (CR's), Deviations & other documentation (in conjunction ... & approves documentation for Quality approval - components/raw material, batch records , change control requests, deviations & validation documents Performs QA… more
- Novo Nordisk Inc. (Milwaukee, WI)
- …relevant local stakeholders, to empower proactive, systematic, and chronic medical management of Obesity and foster relevant use of Pharmacotherapy. Responsible for ... the delivery of Obesity education beyond HCPs, to support the medical management of Obesity. This may include practices, health systems, bariatric/weight … more
- Novo Nordisk Inc. (Minneapolis, MN)
- …relevant local stakeholders, to empower proactive, systematic, and chronic medical management of Obesity and foster relevant use of Pharmacotherapy. Responsible for ... the delivery of Obesity education beyond HCPs, to support the medical management of Obesity. This may include practices, health systems, bariatric/weight … more
- Novo Nordisk Inc. (Durham, NC)
- …and help us make what matters. The Position Ensures Batch Production Records (BPRs) & relevant quality processes are compliant with regulations. Performs quality ... local SOPs Reviews & approves documentation for Quality approval - batch records & other documentation Supports & reviews investigations & root-cause analysis… more
- Catalent (Manassas, VA)
- …to ensure adherence to company quality standards. Communicate any deviations to management . Assist the Quality Assurance team with special projects as required. ... of all tasks relating to issuance of Batch production records and maintenance of cGMP and SOP records...Ability to communicate with all line level positions and management ; Knowledge of spoken Spanish is a plus Must… more
- Novo Nordisk Inc. (Tacoma, WA)
- …trends, and competitors products or services Maintain required activity records /reports, including timely and accurate transmission of call data Participate ... with those individuals Recognize opportunities to productively challenge HCPs clinical management of patients that respects their knowledge and experience and adds… more
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