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Aurora, IL, 60505
... Experience utilizing ERP systems (MES) DMAIC, SIPOC and other Six Sigma and Lean Principles as well as EHS and FDA exp. WORK HISTORY Pharmacy Technician Aurora, IL Jewel/Osco Jul 2020 to present ●Licensed Pharmacy Technician responsible for creating ...
- 2023 Oct 22
Willowbrook, IL
... •Consultant to launch medical compliance for personal health and Guided Therapy (IGT) connected product lines, achieving FDA and HIPAA certifications. Prachi Kumar ad0cnv@r.postjobfree.com Page 2 SharkNinja August 2020 – April 2021 Chief Technology ...
- 2023 Oct 13
Elk Grove Village, IL, 60007
... (Dressings and BBQ Sauces, Private Label) Elk Grove Village, IL •Facilitated announced and unannounced third party audits and two FDA inspections • Reduced downtime by modifying specifications based on process capability • Changed technician ...
- 2023 Oct 09
Round Lake, IL
... For example, life cycle requirements for medical device software, FDA Quality System Regulation for medical devices, GMP, GDP, QMS requirements for Regulatory purposes, LIMS, COTS, Clinical Trials, Medical Device, Risk Management, & CIA training ...
- 2023 Oct 02
West Chicago, IL
... Validation Consultant (November 2013 – June 2016) Review validation documentation for compliance with FDA and ISO standards. Created IQ/OQ/PQ protocols for production equipment. Revalidated equipment/systems. Assisted in evaluating the risk ...
- 2023 Sep 28
Deerfield, IL, 60015
... Schaumburg, IL Senior Labeling Associate August 2017 to December 2018 •Interfaced with CMO’s and internal stakeholders to create and update label copy for FDA submissions or to respond to deficiencies or RLD updates. •Supported labeling manager in ...
- 2023 Sep 27
Lake Zurich, IL
... Authored Installation Qualification (IQ) / Operational Qualification (OQ) procedures to qualify 125 systems to address FDA Consent Decree / CAPA observations & reviewed each completed submission. Performed laboratory layouts and facilitated ...
- 2023 Aug 25
Evanston, IL
... Supported the 2022 FDA Inspection and provided a comprehensive and timely response. Provided DMF revision and regulatory registration guidance. Developed functional Quality (QA and QC) KPIs and reported at Board of Advisors meetings. Provided Batch ...
- 2023 Aug 25
Batavia, IL, 60510
... ●Supported all corporate Maintenance Reliability initiatives: Critical equipment, labor & spare parts tracking, WO & PM Compliance KPI ●Custom Report & Application design: JDE ERW / FDA, data mapping, event rules, business function specifications ...
- 2023 Aug 23
Arlington Heights, IL
... ● Manually composed surgical and medicinal kits according to FDA instructions, documenting lot numbers and quantities of material used, maintaining accuracy in creating, inspecting materials, and building product DRx Pharmaceutical Consultants, Inc. ...
- 2023 Aug 22