- Merck & Co. (Durham, NC)
- …required to successfully support the QC laboratory Team to include the following: Quality Manager overseeing analytical testing and personnelLead the team and ... events Other: Direct support of regulatory inspections and auditsDirect support of validation activities and all other associated Quality functions.Other duties… more
- Merck & Co. (Durham, NC)
- …bulk active ingredient, finished product, and laboratory testing for the BCG vaccine.The Quality Operations Laboratory Manager leads a team of analysts in the ... to work cross-functionally with existing Laboratories and organizations. The Laboratory Manager will be responsible for start-up testing in new laboratories using… more
- Merck & Co. (North Wales, PA)
- …including 21-CFR-Part-11, Annex 11, Good Laboratory and Clinical practices, Computer Systems Validation , and other global regulatory requirements that impact ... Human Use (ICH) guidelines.-Maintain quality standards: Responsible for maintaining high- quality standards for PV processes and systems , and for implementing… 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 for the ongoing site ramp-up, daily operational management, as well… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …records for regulatory inspections and internal audits.Ability to utilize multiple electronic quality systems and SAP.Knowledge of cGMP regulations and FDA/EU ... by management and continue to develop professionally.Strong proficiency utilizing electronic Quality Systems per curriculum.Utilizes tools within MS Office and… 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. (Plainsboro, NJ)
- …relationship with key stakeholders and senior management within Finance, Legal, IT, Quality , Compliance and Product Safety. Leads an Operations team comprising up to ... based on KPIs, while delivering on the objectives of process agility, quality output, strong collaboration, and high productivity from team members. Ensures the… 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 (Northborough, MA)
- …these functions, Packaging interacts with and receives support from the Quality Assurance, Materials Management, Facilities Engineering, Validation , Metrology ... Follow operational procedures and both written and verbal instructions from the supervisor/ Manager . Perform manual packaging on an assembly line. Ability to lift up… more
- AbbVie (North Chicago, IL)
- …Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description Purpose The Manager Validation Quality Systems is responsible ... external partners for development of best practices in our validation quality systems and procedures....in both team setting and independently. Works well with manager guidance while able to manage own time. +… more
- Bristol Myers Squibb (Indianapolis, IN)
- …the global leader in radiopharmaceuticals. The Sr. Manager , IT - GxP Computer Systems Validation & IT Process Lead is an integral part of bringing RayzeBio's ... chain, manufacturing and quality domains and supporting technology including Manufacturing systems (MES), Quality systems (LIMS, QMS), Supply chain … more
- PCI Pharma Services (Philadelphia, PA)
- …the future of PCI. Job Title: **Sterilization** ** Manager - Validation , Sterility Assurance, and Utilities/Facilities** Department/Group: Quality / ... By: Dennis Gerlach Approved By: Nancy Dorr **Summary of Objective:** Validation Manager - Sterilization, Sterility Assurance, and Utilities/Facilities is… more
- Regeneron Pharmaceuticals (East Greenbush, NY)
- …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...implements required processes, as needed, to meet expectations regarding Quality . + Participates in regulatory and customer activities. +… 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
- 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)
- …methodology. ? Good working knowledge of electronic health records, registration and data systems . Non-Bargaining Unit, 618 - HSO Drg Validation - MSH, Mount ... **Job Description** The purpose of DRG validation is to confirm that diagnostic, procedural information,...contained in the beneficiary's medical record. Responsible for performing quality reviews of medical records to validate correctness and… more
- Takeda Pharmaceuticals (Lexington, MA)
- …and changes in approaches in work environments. + Demonstrate daily job activities and the Quality Systems and Validation principles in use at Takeda's MA ... engineers in maintaining the program. You will report to Validation Maintenance Manager . **How you will contribute:**...project team members (Engineering, Manufacturing, Quality Control, Quality Operations, Quality Validation , and… more
- Novo Nordisk (Bloomington, IN)
- …for the successful delivery of process equipment and utilities. Relationships Reports to: Manager , Validation Essential Functions + Equipment Validation : + ... plans, protocols, and reports related to commissioning, qualification, and validation of simple systems and processes. This...+ Ability to use Excel, Word, and other office systems + Ability to learn and use quality… more
- Novo Nordisk (Clayton, NC)
- …compliance & technical reviews/approvals of protocols & protocol data + Author project quality masterplans (PQMP's), validation plans (VPL's), & other key ... source of expertise in the group for validating new systems + Ensure compliance of validation protocols...Master's Degree preferred + Minimum of seven (7) years validation or quality related discipline experience in… more
