- Cognizant (San Francisco, CA)
- …automation programs. . Deep knowledge of GMP, regulatory requirements, and computer system validation . . Excellent communication and documentation skills. ... and change control procedures. . Ensure compliance with GMP, CSV, and internal validation policies. . Maintain hardware design and testing standards and templates. .… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- …+ Participate in commissioning and qualification of IT systems and assist in Computer System Validation (CVS) activities, such as draft URS, IQ/OQ/PQ ... documentation and validation protocols, maintain and manage SOPs related to IT systems and provide user training as needed. Collaborate closely with vendors and… more
- Kelly Services (Indianapolis, IN)
- …maintenance and validation + Instrument cleaning and performance verification + Computer systems validation + LC-MS/MS batch setup and execution + Mobile ... phase preparations + Comply with all laboratory safety procedures, GLP Standards, and all other study-specific or pertinent regulatory agency requirements + Documents activities in the required manner. + Maintenance of neat, accurate, and complete records. +… more
- Quality Consulting Group (Villalba, PR)
- …Bachelor degree in Engineering + Two (2) years of relevant experience. + Process Validation , Equipment IQ and Computer software validation knowledge + ... Technical writing knowledge and Communication skills + Investigation and root cause analysis skills + Availability for 1st shift Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for… more
- Lilly (Lebanon, IN)
- …both technical and non-technical audiences * Knowledge of GMP, regulatory requirements, computer system validation **Basic Requirements:** * Minimum BS in ... with Lilly quality standards including the development and execution of validation strategies and associated documentation * Automation support for capital projects… more
- Cardinal Health (Indianapolis, IN)
- … validation , and/or transfer protocols, analytical equipment qualification protocols, or computer system validation test scripts, as needed. + Performs ... stability testing in alignment with stability protocols at the prescribed cadence. + Performs laboratory investigations, change controls, deviations, and corrective/preventative actions as needed. + Authors and optimizes SOPs, analytical testing forms, and… more
- Quality Consulting Group (Villalba, PR)
- …Engineering + Minimum of 2 years of relevant experience + Knowledge in Process Validation , Equipment IQ and Computer Software validation + Technical writing ... knowledge and Communication skills + Investigation and root cause analysis skills + Must have good writing skills and communication skills in English and Spanish + Administrative Shift Quality Consulting Group, LLC is an equal opportunity employer, and all… more
- Jabil (Elmira, NY)
- …equipment associated with product launches. + Coordinate and support equipment and process validation lifecycle elements such as computer system validation , ... safety risk assessment, installation qualification, process risk assessment, operation qualification and performance qualification. + Author equipment and process standard operating procedures. + Author test protocols and technical report documents. + Perform… more
- Quality Consulting Group (Humacao, PR)
- …experience. + Statistical Knowledge + SPC Knowledge + Experience and knowledge in Process Validation and Computer software validation + Experience in Medical ... Devices + Shift: 1st (40 hours per week) Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity,,… more
- Lilly (Lebanon, IN)
- …both technical and non-technical audiences * Knowledge of GMP, regulatory requirements, computer system validation **Basic Requirements:** * Minimum BS in ... with Lilly quality standards including the development and execution of validation strategies and associated documentation * Automation support for capital projects… more