- 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
- Merck & Co. (Durham, NC)
- …Senior Project Manager is responsible for providing project management support for our Company manufacturing sites in Durham, North Carolina. This position ... varying size and complexity in alignment with the Site Capital Portfolio to support key business needsManage all phases of capital project from conceptual design… 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
- Aequor (Austin, TX)
- …for signature, and store for compliance. Ideal Capital Projects Sourcing Manager candidate: 5 years hands-on capital construction experience in procurement and ... and execution. is searching for a Capital Projects Sourcing Manager , who will be responsible for helping execute the...medium capital projects in a to million range Provide support to a variety of spend sub-categories including Architectural… 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
- 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
- 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
- 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)
- In this role, you will perform validation studies through the analysis of biological samples. Our clients trust us to deliver excellence in data and bioanalysis, and ... objectives. Playing a pivotal role in our project lifecycle, you'll conduct validation studies on a spectrum of biological samples, ranging from biologics and… 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. (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
- Novo Nordisk Inc. (West Lebanon, IN)
- …Other duties as assigned Support and participate in site shutdown activities Support Event Response Process Performs all job duties and responsibilities in a ... Facilities services, performance reviews and on-call scheduling. Relationships Reports to: Manager of Facilities 2nd Shift Essential Functions Coaching and mentoring… 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
