- 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
- Novo Nordisk Inc. (Durham, NC)
- …Relationships Manager . Essential Functions Ensure accuracy & compliance of validation & equipment records Responsible for validation of QC equipment ... help us make what matters. The Position Plan, manage & perform laboratory validation activities. Routine review of laboratory validation procedures & completed … 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
- 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
- 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
- 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
- Aequor (Libertyville, IL)
- …variances and proactively control costs to stay within budget. Follow change control process .Portfolio Financial and Reporting: Support Site IT lead and Global ... Continuously improve our adoption and maturity of best practices across IT. Provide support to IT BPs and DCMs in management of program/project financials, vendor… 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
- 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)
- …priorities and handle multiple tasks simultaneously in a changing environment, with support from Line Manager .Works effectively in a matrix multicultural ... Job DescriptionWith support of Sr CRA/CRA Clinical Research Associate) and/or CRA Manager , acts as primary site contact and site manager throughout all… more
- Merck & Co. (Rahway, NJ)
- …set priorities and handle multiple-tasks simultaneously in a changing environment, with support from Line Manager .Works effectively in a matrix multicultural ... Job DescriptionWith support of Sr CRA (Clinical Research Associate) and/or CRA Manager , acts as primary site contact and site manager -throughout all phases… more
- Novo Nordisk Inc. (Durham, NC)
- …changes to existing systems. Performs archiving duties & QA presence & process confirmation on shop floor. Relationships Manager , Quality Assurance. Essential ... approval - components/raw material, batch records, change control requests, deviations & validation documents Performs QA presence & process confirmation on shop… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …supporting technological and data innovation, insights and analytics, delivering patient support solutions, maintaining our facilities and assuring the integrity and ... the business function in designing and developing IT solutions. In the support role of existing systems, this role provides knowledge, testing, documentation,… 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
- Merck & Co. (Durham, NC)
- …remains in state of control based on Sterility Assurance requirements ensuring an integral process .-Lead a Quality team to provide QA support to assigned areas ... standards of quality. The Quality Assurance Associate Director will provide critical support in Teknika's continued efforts with supplying the market though leading… more
- Novo Nordisk Inc. (Boulder, CO)
- …Inc. in December 2021. With a new laboratory completed in 2021 to support analytical and process development, the CMC team works alongside Quality, ... individual contributor. Daily interaction with other peers in analytical development and/or process development teams in support of early phase product pipeline.… more
- American Honda Motor Co Inc (Raymond, OH)
- …/ Reliability / Ext Perf DevelopWork Location: Auto Development CenterHiring Manager : Randy R WildeShift: 1stCareer Level: 4Job Grade: Exempt-3 Job ... analyses to be resolved. Initiate and lead engineering solutions and the associated validation processes for assigned vehicle segment or functions to gather data and… more
