- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as Validation Plans, Protocols (IQ/OQ/PQ), Test Scripts and Summary Reports. Support the change management process for validated systems where ... performance indicators and participates in SDLC Lessons Learned sessions to evaluate validation process improvements and efficiencies and measure key success… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …process capability. Support manufacturing to satisfy the quality and process validation requirements for existing products. Participate in the development ... and requirements for validationDevelop and implement strategies for equipment IQ/OQ/PQ, process validation , computer system validation and calibrationPerform… more
- Catalent (St. Petersburg, FL)
- …Validation , Bulk Mfg Protocol and Reports (non-GMP, Clinical, Registration, Process Validation , Product Transfer, etc.), Risk Assessment, Formulation Reports, ... Manager , QA (Product Development)Position SummaryThe Quality Assurance Department...effectiveness checks.Bulk Mfg Protocols and Reports (non-GMP, Clinical, Registration, Process Validation , Product Transfer)Master Batch Records; and… more
- Novo Nordisk Inc. (Durham, NC)
- …met Manage and develop departmental procedures & maintain SOPs according to cGMP Support process equipment validation activities Serves as primary interface ... well as internal stakeholders for the success of the Site. Relationships Manager , FUSE. Essential Functions Ensures all safety & environmental requirements and… more
- Merck & Co. (North Wales, PA)
- …Real-World Evidence (RWE) Operations organization within V&I GMVC and provides support across all elements of management and execution of non-interventional studies ... health economic model development and adaptations, dossiers, other activities in support of HTA, and publications.- Supports Scientist(s) in V&I Outcomes Research,… more
- Catalent (St. Petersburg, FL)
- …b) process improvement projects and Product Development Projects; c) all product process validation and cleaning validation documents; d) all Preventive ... QA Product Manager Position SummaryThe QA Product Manager ...is responsible for providing Leadership and Quality Assurance Management support within at Catalent's St. Petersburg site. The Department… more
- Catalent (St. Petersburg, FL)
- …to the safety of every patient, consumer and Catalent employee. Compliance Manager is responsible for providing Leadership and Quality Assurance Management ... support within Catalent's St. Petersburg site. The Department has...Equipment/Facilities, Change Control, etc. The focus of each QA Manager may be dependent upon the needs of the… more
- BioAgilytix (Durham, NC)
- …is ingrained within our bioanalytical technology teams, providing a variety of project support through all phases of our client services. As a Project Manager ... to the actions required of an efficient and quality-driven project process . You'll experience a broad range of responsibilities spanning study administration,… more
- Novo Nordisk Inc. (Durham, NC)
- …including a thorough understanding of cleaning, equipment, utility, computer & process validation requirements & concepts is required Excellent written ... is on site as needed during production activities Coordinate all validation /transfer activities involving MDev support Lead team in successful execution… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …opportunity employer including veterans and people with disabilities. Summary The Manager External Data Management, is accountable for an end-to-end delivery of ... CROs and External Vendors for the data services they provide to support drug development processes and global submissions.This position provides expertise within… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …routine manufacturing and protocol driven activities such as tech transfer and process validation Provides guidance on industry best practices, and quality ... multiple myeloma. Legend Biotech is seeking QA Manufacturing Excellence Manager as part of the Quality team based in...will be a subject matter expert for the manufacturing process and provide front line support to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …timelines and improves quality. Coaches and mentors' colleagues on the outsourcing process and procedures. (not a formal people manager ). Develops detailed ... This position will work cross-functionally to execute the outsourcing process . Responsible for appropriate utilization and application of advanced negotiation… more
- Aequor (Libertyville, IL)
- …experience. Must Have List: Knowledge of IT service management platforms to support incident, problem and change IT operational events (ie ServiceNow). Knowledge of ... documentation practices. Job Description: The Enterprise Systems and IT Service Support position will be responsible for understanding and supporting the integration… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …accuracy and precision requirements primarily focused o pharmaceutical operations and support equipment Develop, test, and validate, automated and manual calibration ... transfer traceability from Primary Standards to Laboratory Working StandardsSupport validation and production engineers in development of metrological specifications… more
- Merck & Co. (Rahway, NJ)
- …assigned protocols and sites in a-country.-Under the oversight of the CRA manager the person ensures compliance of study conduct with-ICH/GCP and country ... requirements internally and externally.Acts as primary site contact and site manager throughout all phases of a clinical research study,-taking overall… more
- Merck & Co. (Durham, NC)
- …Preventative Maintenance (PM) plans as requested. Responsible for SAP transactions, validation testing support , supporting root cause investigations and change ... Tech, Engineering is a member of the Engineering team providing technical support to the manufacturing site. The site includes clean utilities, facilities equipment,… more
- Merck & Co. (Durham, NC)
- …development and reviewDirect support of regulatory inspections and auditsDirect support of validation activities and all other associated quality ... Associate is responsible for all Quality related functions that directly support Durham within the Vaccine Manufacturing Facility while actively participating in… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …maximize your potential with us? The Position This position is responsible for providing support to the Senior Manager and Director of Institutional Contracts by ... supporting technological and data innovation, insights and analytics, delivering patient support solutions, maintaining our facilities and assuring the integrity and… more
- Novo Nordisk Inc. (Durham, NC)
- …(in conjunction with LoB). Performs archiving duties and QA presence & process confirmation on shop floor. Relationships Manager , Quality Assurance. Essential ... other documentation Supports & reviews investigations & root-cause analysis Participates in process confirmations & Go Look Sees Follow all safety & environmental… more
- BioAgilytix (Boston, MA)
- …objectives. Playing a pivotal role in our project lifecycle, you'll conduct validation studies on a spectrum of biological samples, ranging from biologics and ... plate mapsServe as lead analyst on sample analysis projectsTroubleshoot assaysCompile/ process data (make power export)Prepare summary tablesPeer review raw dataOrder… more
