- Cardinal Health (Indianapolis, IN)
- … validation , and/or transfer protocols, analytical equipment qualification protocols, or computer system validation test scripts, as needed. + ... of relevant work experience working with 21 CFR 210, 211 in the FDA regulated industry (Pharmaceutical or Medical Device) preferred. + Has experience in authoring… more
- Jabil (Elmira, NY)
- …and support equipment and process validation lifecycle elements such as computer system validation , safety risk assessment, installation qualification, ... trending. + Gain exposure to concepts of GMP/GXP as well as introduction to FDA , ISO, Safety, and Environmental regulations. + Act as team member supporting capital… more
- Colgate-Palmolive (Emporia, KS)
- …more years of experience in an analytical laboratory. + Knowledge of quality systems . + Computer skills including email, spreadsheet, presentation and database ... is also responsible for driving efficiency and efficacy of all quality systems in the Emporia, Kansas facility. **Core Responsibilities:** Understands and is… more
- ThermoFisher Scientific (Middletown, VA)
- …team skills. + Lead learning and education initiatives on Quality Assurance systems and Standard Operating Procedures (SOPs) to maintain compliance. + Monitor, ... and ISO requirements to support regulatory compliance objectives. + Complete spreadsheet validation training and oversee validation activities to maintain data… more
- Catalent Pharma Solutions (St. Petersburg, FL)
- …train junior colleagues; contribute to continuous improvement within the group. Comply with FDA , EPA and OSHA regulations, performing all work in a safe manner. ... FL location. **The Role** + Performs analysis of finished products, validation samples, in-process materials and raw materials, moisture testing, Gas, Water… more
- Contract Pharmacal Corp (Hauppauge, NY)
- …best practice standards. + Collaborate with Facilities Maintenance, Engineering, Validation , and other cross-functional teams to coordinate activities related to ... with relevant departments. + Utilize maintenance and/ or project management systems to establish and track documentation and schedules. + Other responsibilities… more
- BD (Becton, Dickinson and Company) (Canaan, CT)
- …performance to meet goals and schedules. Ensures compliance with BD quality systems , policies, procedures and best practices, and all local, state, federal and ... investigations as appropriate. Responds to product defect notifications. + Authors validation and change control protocols and provides input during the execution… more
- Philips (San Diego, CA)
- …projects (SaMD) as well as software-related aspects of complex medical systems (SiMD). Manages the development, oversight and execution of comprehensive software ... internal policies throughout the software lifecycle. + Authorizes/Leads the assessment, validation and approvals of software designs/inputs, overseeing the review of… more
- Jabil (Hunt Valley, MD)
- …major and/or experience working in a regulated life-science. . Strong understanding of FDA 's Six- System Audit Schema . Ability to effectively present information ... customers, and other entities as it pertains to Pii's Systems and Processes. . Ability to define problems, collect...valid conclusions. . Advanced skill to operate a personal computer including using a Windows based operating system… more
- BioFire Diagnostics, LLC. (Hazelwood, MO)
- …With engineering centers in the United States, France, and Italy, our Systems Development team collaborates globally to build products that ensure patient health ... Click Here to "Be More" - With the bioMerieux Systems Development Team (https://www.youtube.com/watch?v=hpzozgabt88) Description We develop equipment, tests and… more
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