- IBM (Research Triangle Park, NC)
- …the design standards and guidelines, to be used for initial budgeting and validation of service provider estimates. On-going validation of scope requirements to ... issuance of purchase orders, invoicing, change orders and reconciliation and validation against contract scope. Deep knowledge of Design and Construction processes,… more
- Catalent Pharma Solutions (Morrisville, NC)
- …for the execution of assigned activities for technical support and process validation related to new products, processes, equipment, and troubleshooting of current ... site.** **Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent… more
- Lilly (Durham, NC)
- …activities and is responsible for addressing any sterility or product quality related questions during manufacturing. The Technician will work closely with ... Parenteral Facility. As designated by management, additional support for qualification/ validation activities or other routine responsibilities within the TS/MS group… more
- ThermoFisher Scientific (Greenville, NC)
- …documents, and communicates test results. **Key Responsibilities:** + Lead the validation of test methods for pharmaceutical raw materials and finished products ... Perform daily instrument calibrations/verifications as required. + Write and complete validation protocols in accordance with regulatory guidelines + Review and… more
- Cognizant (Raleigh, NC)
- …studio Experience in C# and object-oriented programming concepts Author Computer System Validation (CSV) documents such as Functional Risk Assessment, Validation ... Plan, System Test Plan, Test Summary Reports (IQ/OQ/UAT), Validation Report, etc. following industry standard GAMS 5 and/or...following industry standard GAMS 5 and/or following the client Quality standards. Author and review test scripts (IQ, OQ,… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …compliance of upstream operations through effective technology transfer, validation support, process monitoring, troubleshooting, and lifecycle management activities ... trends, and propose process improvements. + Support process characterization and validation activities (PPQ) for upstream processes executed at CDMOs. + Evaluate… more
- PNC (Raleigh, NC)
- …subject matter expert to assigned areas and review model documentation and model validation reports to determine if the models are conceptually sound and compliant ... the remediation testing plan, deep dive into model documentation, model validation reports, other supporting material and analyses, and meetings with clients… more
- ThermoFisher Scientific (Greenville, NC)
- …documents, and communicates test results. **Key Responsibilities:** + Lead the validation of test methods for pharmaceutical raw materials and finished products ... Perform daily instrument calibrations/verifications as required. + Write and complete validation protocols in accordance with regulatory guidelines + Review and… more
- Lilly (Concord, NC)
- …. Build and maintain awareness and knowledge of regulatory, legal, or quality requirements impacting the business areas, and ensure that solution requirements comply ... next generation MES team and third parties in the validation of the MES System during the deployment of...issue escalations . Produce and maintain local project and validation documentation . Ensure systems remain in a validated… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …without specific direction to do so. An Assistant Biologist participates in Quality Control studies (blind testing series, validation protocols, precision, and ... by creating innovative products and services based on the values of ethics, quality and responsibility. Grifols' activities focus on fulfilling the needs of its… more