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FDA resumes in Painesville, OH

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Document Control Operations Specialist

Rock Creek, OH, 44084
... EDUCATION Bachelor of Arts University of Akron EXPERIENCE SENIOR REGULATORY OPERATIONS SPECIALIST / STERIS-CORPORATE (NOV 2021 – APRIL 2024) • Manage Document Control for AST BU Global Quality Management System • Completed the FDA annual ... - May 06

Shipping Receiving Quality Inspector

Willowick, OH, 44095
... Work Experience TT Electronics Perry, Ohio 6/23 – Present Quality Inspector Level III Quality audits (internal, external) Quality inspections/1st articles Familiar with FDA regulations/ ISO 13485 Military/defense regulations NCR and Customer ... - Mar 15

Customer Service Content Writer

Madison, OH
... Ensures label and packaging designs accommodate and comply with Hazardous Materials / Dangerous Goods classification, FDA, EPA and DOT regulations Maintain / Redesign / Revising & proofing of all labeling for consumable packaging based upon ... - Jan 31

Data Entry Clinical Research

Mayfield, OH
... May be responsible for reporting/completion of Serious Adverse Events and/or safety log as defined per protocol as they occur and completion of Food and Drug Administration (FDA) and sponsor forms in accordance with GCP guidelines. Communicates with ... - 2023 May 24

Engineer Software

Mentor, OH, 44060
... Steris Validating user tools both in house and third party, based on FDA & Steris requirements Generation and Management of all necessary Quality Document, Including but not limited to Assessment, Requirements, Test Procedure, & Test Scripts. ... - 2020 Feb 03

Medical Technologist Laboratory

Euclid, OH
... The blood and blood products processed by this institution are FDA regulated and require GMP guidelines which include the extensive documentation of all procedures performed. WARDE MEDICAL LABORATORY, ANN ARBOR, MICHIGAN (2/05 to 10/05) Employed as ... - 2018 Apr 14

Quality Assurance

Willoughby, OH, 44094
... • Successfully hosted 4 FDA inspections, and 5 notified body inspections (New Jersey Department of Energy, AABB, NMDP, HRSA and New Jersey Department of Health) • Launched HIPAA/Privacy program in the eastern district. Served as Chief Privacy ... - 2018 Mar 30

Manager Project Management

Painesville, OH, 44077
... Regulatory Knowledge and Compliance: Deep understanding of regulatory frameworks and ISO and IPC procedures, processes, and standards such as FDA GMP; Mil-Spec 883 Class S (Space) and Class B (Mission Critical); AS9100; ISO 9000, TS 16949, and IS0 ... - 2018 Mar 26

Engineer Customer Service

Beachwood, OH, 44122
... for test execution • IEC 60601 Standards • Reviewed test results to meet FDA standards • Worked with system and subsystem team members to resolve defects and other issues • Troubleshot and resolved software and hardware issues on CIRS Invacare Inc. ... - 2018 Jan 29

Customer Service Mechanical Engineer

Mentor, OH, 44060
... Specifically, attended FDA remediation in 2016 assuring program validation. Accounted for the hardware program audits and monitored regimens; successfully identifying potential risk outliers, and completed all compliance resolution disputes. Approve ... - 2018 Jan 17
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