- Exela Pharma Sciences, LLC (Lenoir, NC)
- …The Quality Engineer will participate in Internal Audits as directed by the Quality Manager . In addition, the Quality Engineer will lead continuous ... to product, processes, and equipment changes on critical attributes and quality architectures.Commissioning, Qualification and Validation - provide Quality… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Manager , Data Programmer is a member of the Biostatistics and Data Management ... SDTM and collaborating with CROs and other vendors to ensure high quality deliverables to support drug development processes and global submissions as required… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …together to contribute to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a patient-focused mindset guides everything ... for architecting and coordinating the design, installation, commissioning, startup and validation of all assigned new capital improvement projects. Primary the… more
- Aequor (Swiftwater, MN)
- …Track and review change control documentation. Assist with the editing of quality documents (SOP's, guidelines, validation master plans, etc.) to ensure ... interacting with others. Review current documents- incorporate comments from Manager . Navigate through pasteur EDoc (Documentum) system utilizing current templates.… more
- Novo Nordisk Inc. (Durham, NC)
- … Quality Control and LIMS software experience is highly desirable. Relationships Quality Control Senior Manager . Essential Functions Support plans to maintain ... our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world. In NC, we operate… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position SummaryThe QC Chemistry Finished Product Supervisor will report directly to quality upper management, (QC Senior Manager ), and will provide both ... and Implement Standard Operating Procedures according to cGMP and cGLP.Assist in validation of new test methods for raw material, in-process, and finished product… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …study team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data.- Drug Development Strategy: Provides ... CRF review, SAP development, analysis files development, statistical analysis accuracy validation , results interpretation and CSR input and review. Acts as main… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …together to contribute to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a patient-focused mindset guides everything ... with relocation assistance eligible for selected candidate. Relationships Reports to: Manager of cLEAN & Training Number of subordinates with direct/indirect… more
- Fujifilm (College Station, TX)
- **Overview** The Quality Assurance (QA) Manager , QA Validation , will be responsible for the review and approval of commissioning/qualification/ validation ... handle all associated responsibilities in compliance with FUJIFILM Diosynth Biotechnologies quality policies and site SOPs to ensure regulatory compliance. **Reports… more
- Boehringer Ingelheim (Ridgefield, CT)
- …exchange with other companies 3. Contribute on strategic topics as requested by the manager . Define proactively and oversee validation concepts to be ready for ... regulated environment (with minimum of 5 years)with focus on quality assurance and/or computer system validation . +...focus on quality assurance and/or computer system validation . + Strong written and oral communication skills, ability… more
- PCI Pharma Services (Philadelphia, PA)
- …and coordinates resources for protocol execution. + Collaborates with the site commercial Validation Manager for any validation overlap. + Assures regulatory ... and shape the future of PCI. **Summary of Objective:** Validation /Sterilization Manager is responsible for qualification, ...Team and PCI PHL Customer Programs. Participate in site quality management reviews and reports on Validation … more
- Regeneron Pharmaceuticals (East Greenbush, NY)
- The QA Validation Fill Finish team is hiring a Manager ! As the Manager , QA Validation you will validate/qualify equipment, systems, and processes related ... to cleaning, sterilization, and Aseptic Process Simulation Validation in accordance with regulatory requirements and support, follow and implement company… more
- Bristol Myers Squibb (Devens, MA)
- …and in their personal lives. Read more: careers.bms.com/working-with-us . **Position:** Manager , Cleaning Validation , Validation Engineering **Location** : ... Ensure alignment with BMS directives and industry guidelines on cleaning validation and quality engineering. + Leads and/or executes validation work arising… more
- West Pharmaceutical Services (Scottsdale, AZ)
- Sr. Manager , Process Validation Requisition ID: 68535 Date: Jan 16, 2025 Location: Scottsdale, Arizona, US Department: Engineering Description: At West, we're a ... is responsible for contributing to the development and implementation of the validation engineering strategy for West Global Technical Operations whilst ensuring the… more
- TD Bank (Mount Laurel, NJ)
- …meet validation lead time target. + Work with team to deliver high quality model validation reports with adequate information and justification to support ... Business:** Analytics, Insights, & Artificial Intelligence **Job Description:** The Senior Manager , Advanced Analytics leads a specialized team of data professionals… more
- Takeda Pharmaceuticals (Columbus, OH)
- …If so, be empowered to take charge of your future at Takeda. Join us a Manager , Clinical Data Validation Engineer in our Cambridge, MA office. At Takeda, we are ... trial deliverables. As part of CDE, the Clinical Data Validation Engineer (DVE) group leads validation and...of Clinical Study teams to foster an environment of quality and efficient specifications and documentation to support audit-readiness… more
- Bristol Myers Squibb (Indianapolis, IN)
- …entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals. The Sr. Manager , IT - GxP Computer Systems Validation & IT Process Lead is ... address process deficiencies. Work collaboratively with peers within various departments and Quality groups. + Provides validation subject matter expertise (SME)… more
- Eurofins (Charlotte, NC)
- …areas of bio/pharmaceutical manufacturing, including method development, microbiology, process validation and quality control. Position Summary Eurofins BPT ... is seeking a results-oriented Regional Sales Manager to join our team, focusing on facility ...Manager to join our team, focusing on facility validation and environmental monitoring solutions for the biopharmaceutical and… more
- Carnival Cruise Line (Miami, FL)
- The Manager , Data Validation is responsible for the design and delivery of the MAST data validation process for all brands within the Carnival Corporation. ... Strategy, this role will be responsible for managing data quality assurance, tracking delivery of tasks on-time during ship...of the MAST Program + Oversee the end-to-end data validation process for core, reference and transactional data which… more
- Mount Sinai Health System (New York, NY)
- **Job Description** The purpose of DRG validation is to confirm that diagnostic, procedural information, and the discharge status of the beneficiary, as coded and ... information contained in the beneficiary's medical record. Responsible for performing quality reviews of medical records to validate correctness and appropriateness… more
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