- Eurofins (Lancaster, PA)
- …perform software/firmware upgrades, update user account information, and complete periodic system compliance reviews. + Validation Testing - Determine and/or ... + Compliance - Ensure projects are completed in compliance with existing quality systems . Stay current with client, regulatory, validation , IT, and e-record… more
- Amgen (Holly Springs, NC)
- …Data Integrity Assessments for Lab systems + Capable of defending Amgen's Lab systems validation and data integrity philosophy in an Audit situation ... System (CMMS) Maximo. Responsible for authoring/owning and approving Validation Life Cycle documents for computer related systems...school diploma / GED and 10 years of cGMP laboratory , analytical instrument validation , and/or… more
- Amgen (Holly Springs, NC)
- …**Basic Qualifications:** + High school diploma / GED and 8 years of cGMP laboratory , analytical instrument validation , and/or Process Engineer experience OR ... System (CMMS) Maximo. Responsible for authoring/owning and approving Validation Life Cycle documents for computer related systems...+ Associate's degree and 6 years of cGMP laboratory , analytical instrument validation , and/or… more
- Digital Prospectors (Woburn, MA)
- … lab systems . + Approve BMRAM work orders for lab systems . + Review and approve validation lifecycle documents (ie, SLRA, DI Assessments, DR/DQ, ... focus on quality and/or validation . + Hands-on experience with analytical instrument qualifications, computer system validation , and data integrity… more
- Biomat USA, Inc. (Seattle, WA)
- …limited to instrument configuration, LIS connectivity, customer training and instrument validation support + Independently coordinates and provides technical ... support staff with identification, analysis, and resolution of complex instrument implementations, including pre-installation planning to resolution of post-implementation… more
- Fujifilm (Thousand Oaks, CA)
- …we call Genki. The QC Instrumentation Specialist will a** **uthor, review, approve laboratory procedures, instrument validation , CAPAs, deviations and change ... validation for both direct and indirect GMP impact systems . The candidate must have strong GMP experience with...Up to 10% **Primary Responsibilities:** + Author, review, approve laboratory procedures, instrument validation , CAPAs,… more
- West Pharmaceutical Services (Exton, PA)
- …support for maintaining the instrument quality program including the creation of validation documents. The Specialist must work with Lab Operations, D&T, and ... and maintain the quality management system for laboratory instruments. + Support and maintain the instrument...and activities for new installation projects. This includes creating instrument validation plans and change controls for… more
- Curia (Burlington, MA)
- …the following duties: * Conduct equipment qualification, specifically laboratory instrument qualification, which includes software validation ; * Develop and ... with Engineering and Facilities personnel to ensure proper installation and operation of systems prior to and post- validation . Provide technical support to users… more
- BioFire Diagnostics, LLC. (Hazelwood, MO)
- …of a product-development organization (medical-device or biotech industry) preferred*Familiarity with Lab Information Systems (LIS) and instrument ... and executing lab - validation protocols and performing instrument - validation testing*Demonstrated ability to gather customer requirements and create… more
- University of Rochester (Rochester, NY)
- …finance and budgeting, creation of a business plan, instrument validation and selection, administrative functions of laboratory medical directors at ... Medical Center: School of Medicine and Dentistry: Pathology & Lab Med **Salary Range or Pay Grade** 85376.00 **Description**...the hospital and system level, strategic planning, laboratory standardization in systems , laboratory … more