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Resume alert |
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Bloomington, IN
... 2019 - June 2023 Sustaining Engineer II Led 5 projects for EU MDR remediation while reviewing, supporting, and coordinating work of up to 5 contractors, and led 9 projects updating labeling for FDA 510k remediation on various urological devices. ...
- Mar 21
Bloomington, IN
... IURA, PHA, dFMEA/aFMEA/FTA, Prototyping, Performance testing, FDA V&V strategies, DHF, and DMR. BS OF BIOMEDICAL ENGINEERING TEXAS A&M UNIVERSITY GPA 3.54 HONORS CREDITS: 86 AUG 2018 – MAY 2021 ACTIVITIES AND SOCIETIES: Engineering Honors College, ...
- 2023 Mar 06
Bloomington, IN
... Implement and maintain compliance with current good manufacturing practices (cGMP), environmental health and safety (EHS) guidelines, and FDA regulations. Maintain department support exceptions and requirements, document review, employee time ...
- 2020 Nov 27
Bloomington, IN
... ● Operating Procedures ● Hydraulics ● Design and Assembly ● Gown IN/Gown Out ● Pneumatics ● Start up/Tear Down ● Pumps and Piping ● Schematics ● FDA EXPERIENCE O’Reilly Auto Parts,Bloomington,IN. Assistant Manager 2016 – Present Oversee day to day ...
- 2019 Oct 24
Bloomington, IN
... Working knowledge of FDA regulations, QSR, ISO, 21 CFR Part 820, ISO 14001. •Authored and created dossier content from source documentation as needed for module registrations and provide writing support for technical reports and global regulatory ...
- 2019 Feb 13
Bloomington, IN
... and development, and quality assurance departments Ensure project team procedures, objectives, and deliverables align with FDA and ISO quality requirements Evaluate technical documentation, identify deficiencies, implement and execute strategies to ...
- 2017 May 03
Bloomington, IN
... Responsible for releasing raw material, in-process, finished product and stability drug substance to ensure purity and compliance with FDA requirements. Responsible for, and supervised the work of twelve Quality Analysts in the laboratory. Duties ...
- 2016 May 03
Bloomington, IN
... Know well about the FDA’s Food and Drug Law and Regulation, and ICH guidance.
- 2014 Jul 25
Bloomington, IN
... I know how to follow all cGMP guidelines and am also aware of all OSHA and FDA regulations. I also follow good documentation practices. I am a hard worker and show up every day on time, and love to work overtime. I have had a few days unscheduled ...
- 2014 May 21
Bloomington, IN
... also with FDA examinations - administrative duties include inventory accounting (weekly and monthly reports), weekly/monthly product trackers, monthly expense reconciliation, product budgeting and sample compliance/distribution reconciliation. ...
- 2014 Apr 25