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Knowledge of cGMP's for Pharmaceuticals and Quality Systems: 21 CFR Part 210, 211 and 820. Exposure to control systems validation within regulated FDA environment. We are looking for a Senior Automation Validation Engineer with a minimum of 10 years experience in Delta V with the implementation and validation of Delta V and OSI PI with Instrumentation and Controls in an FDA regulated environment.
Full-timeExpandApply NowActive JobUpdated 3 months ago - UpvoteDownvoteShare Job
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Experience in clinical research, familiarity with oncology protocols, clinical trials operations, GCP, NCI guidelines and federal regulations both FDA and HHS. Knowledge and familiarity of e-regulatory systems (Veeva), DocuSign, ImageNow and other applications used in the conduct of clinical research along with the relevant regulations.
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This position directly supervises a team of QA Specialists covering a vast functional area centralizing all aspects of product quality, requiring an abundance of knowledge and established interpretation of FDA Quality Systems Approach to Pharmaceutical cGMP Regulations as well as excellent attention to detail in a rapidly growing business environment.
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Experience working effectively with CROs/CSPs. Expe rience with electronic Quality Management Systems and Trial Master File. Skills and Abilities A solid understanding of GCP, GLP, GMPs and CMC requirements is expected.
$155,000 - $190,000 a yearFull-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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At American Vision Partners (AVP) , we partner with the most respected ophthalmology practices in the country and integrate best-in-class management systems, operational infrastructure, and advanced technology to provide the highest quality patient care possible.
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Provides review of technical, validation and other protocols and reports, with emphasis on adherence to quality systems, and with FDA, EMEA, ICH and JP regulations/guidance. Provides quality support within the Pilot Plant in the execution of key quality systems, including equipment, system, and utility validation, SIP, Autoclave, and on-going process improvementefforts.
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Use a variety of laboratory instrumentation (KF Titrator, DSC, HPLC, Particle Size, Tensile Tester, spectrophotometer) and computer systems to collect and record data. Support laboratory equipment qualification Support test method validation Support laboratory investigation and conduct nonconformance investigation Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations.
ExpandApply NowActive JobUpdated 3 months ago - UpvoteDownvoteShare Job
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Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations. Knowledge of basic laboratory and pharmaceutical production equipment including but not limited to: autoclaves, process tanks, incubators, analytical equipment, and CIP/SIP systems.
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Adheres to Integer Values and all safety, environmental, security and quality requirements including, but not limited to: Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and other regulatory requirements.
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Support complex technical quality requirements in specific IT Infrastructure and CSV situations, such as validation of new systems, upgrades, changes or remediation, etc. Demonstrated expertise in at least one aspect of system qualification and regulatory compliance (e.g., FDA, EMEA, GCP, GLP, GMP, QSR, etc.
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And quality management systems (HACCP, SQF, etc. Bachelor's degree in Food Science, Microbiology, Quality Assurance, or a related field. We are a leading dairy and cheese product manufacturer committed to producing high-quality and delicious offerings for consumers across the globe.
$70,000 - $80,000 a yearFull-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Ensures compliance with all applicable federal, state, and local regulatory standards (ex TJC, DOH, FDA, HIPAA, HCFA, DPW, LCGME, SCGME, etc) Achieves proficiency in automated systems; such as EPIC APM and EMR (including inbasket), hospital based EMRs (where necessary), Navinet, credit card machines, IPayment, etc.
Full-timeExpandApply NowActive JobUpdated 16 days ago - UpvoteDownvoteShare Job
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Adhere to Integer's Value and all safety, environmental, security and quality requirements including, but not limited to: Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and other regulatory requirements.
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Internal Stakeholders: Manufacturing, Technology Transfer, Quality Control, Quality Assurance, Warehouse & Logistics, R &D and EH&S. The Maintenance Technician shall adhere to all applicable regulatory requirements, including FDA, EPA, OSHA, and related safety, health and environmental procedures, policies and practices.
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Familiarity with quality-based computer systems such as LIMS. Knowledge of aseptic sampling and testing techniques and microbiological testing according to FDA, cGMP, GLPs and USP testing methodology.
$23.5 an hourFull-timeExpandApply NowActive JobUpdated 3 months ago
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