- 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
- Aequor (Thousand Oaks, CA)
- …or oversee the following functions: a) Review and approve product MPsb) Approve process validation protocols and reports for Mfg. processes. c) Approve ... 1 week a month - multiple short trips. In support of 's Quality Assurance program manages and oversees...with processes involved in manufacturing and distribution, QA, QAL, validation , and process development. Strong communication (both… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …with the Validation Department to participate and provide feedback to NN validation process group Ability to work and communicate effectively across multiple ... Support facility certification for new or upgraded Pharmaceutical Manufacturing ( process equipment and facility- support equipment) and Quality Control… 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
- Aequor (Thousand Oaks, CA)
- …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
- Merck & Co. (Durham, NC)
- …responsible for comprehensive management of all activities required to successfully support Process Performance Qualification (PPQ) and routine manufacturing to ... that ensure required safety guidelines are followed.-Review and approve qualification/ validation documents for equipment and process (ie, IQ/OQ/PQ).Review… 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
- Merck & Co. (North Wales, PA)
- Job DescriptionPosition Description: Senior Study Manager - Epidemiology OperationsSupport the Lead Epi Scientists by providing overall operational support for ... the safety management, data management, communication, project management and validation plansParticipate in protocol and interim/final report preparation, shepherd… 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
- 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
- Merck & Co. (Durham, NC)
- …Automation, Technology, and other groups as required.-Responsible for supporting:- Process Equipment (eg tanks/bioreactors, filtration skids, chromatography columns). ... and collaboration skills responsible for leads peers in supporting the manufacturing process . Individual will possess the ability to lead a team, train others… 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
- 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders.Summary Position leads statistical support for low to medium complexity studies including contributing to ... development, analysis files development, data surveillance review, statistical analysis accuracy validation , results interpretation and CSR input and review. Acts as… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …position is responsible for performing reviews of manufacturing and support documentation and records to certify compliance with in-house specifications/standards ... individual batch records, supporting test records and other ancillary support records. Will be a QA presence on the...based on Quality Assurance record review and approval by Manager , Quality Assurance Review and assess Corrective and Preventive… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …position is responsible for performing reviews of manufacturing and support documentation and records to certify compliance with in-house specifications/standards ... individual batch records, supporting test records and other ancillary support records. Will be a QA presence on the...on Quality Assurance record review and approval by QA Manager Performs regular internal audits of NNUSBPI facilities as… more
- TreeHouse Foods, Inc. (Princeton, KY)
- …of the allergen control program including ingredient labeling, segregation, storage, cleanup process , verification of cleanups, and validation of cleanups, and ... Key drivers are ensuring compliance to specification on incoming ingredients, in- process conditions and finished products. The position also ensures the ongoing… more
- Catalent Pharma Solutions (Bloomington, IN)
- …quality standards and requirements of company policies and FDA regulations. **The Process Validation Manager 's responsibilities include managing multiple ... managing protocol and report development, execution and approval associated with process validation , reviewing and approving documentation, evaluate and… more
