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North Hollywood, CA
... TaqPath COVID-19 Combo Kit used to perform this test has been authorized by FDA under an Emergency Use Authorization for use by authorized laboratories. The test has not been otherwise FDA cleared or approved. This test is authorized only for the ...
- Apr 10
Santa Clarita, CA
... the United States and worked closely with finance in connection with insurance billing, Collaborated with Marketing on social media issues regarding privacy, CCPA knowledge, and Direct dealings with Regulators such as FDA, CMS, OCR and HHS. ...
- Apr 02
Thousand Oaks, CA, 91362
... ●Drug Safety regulations (ICH-GCP, GxP, GVP modules with new Pharmacovigilance legislation, 21 CFR Part 11, FDA,GVP, EU Annex 11, Health Canada and GAMP 5 Standards). SOFT SKILLS ●Observation and ability to grasp faster ●Clear and effective ...
- Mar 27
Winnetka, CA
... Knowledge of FDA and other interna*onal regulatory agencies, RIMS, EDMS, eCTD, Veeva Vault, File Trail, ServiceNow, Oracle, AI, MicrosoS Windows, etc. WORK EXPERIENCE Sr. Associate GRASS AMGEN, Thousand Oaks, CA 04/2004 – 12/2013 • Led the ...
- Mar 13
Newbury Park, CA, 91320
... Areas Of Expertise Quality Management Systems 21CFR 210 and 211, ICH Guidelines Regulatory Compliance FDA/External & Internal Audits/Inspections Batch Record Issuance/Review/Product Release Continuous Quality Improvement Revise/Implement SOPs and ...
- Mar 07
Chatsworth, CA
... Built commercial guidelines in anticipation of FDA approval for MRI accreditation. Regularly updated National Accounts and Medical Science teams. Achieved highest M.G.M.A. results nationwide for orthopedic health care systems with 500 employees and ...
- Feb 29
Newhall, CA, 91321
... AREAS OF EXPERTISE Quality Engineering Management Systems Regulatory Affairs Compliance Monitoring Business Consulting Project Management FDA & International Filings Submissions & Certifications Data & Statistical Analysis Policies & Procedures ...
- Feb 29
Simi Valley, CA, 93065
... Draft new designs and documentation, update existing medical device drawings for FDA, market release and implementation. BOSTON SCIENTIFIC CORPORATION — Valencia, CA Solidworks AutoCAD draftsman designer / Technical Illustrator, 11/03 to 04/10 Draw, ...
- Feb 23
Canoga Park, CA
... a position in regulatory affairs ( Chemistry, Manufacturing and Controls) where can utilize combined knowledge, experience and skills of pharmacology, clinical research, FDA regulations, ICH guidelines, public health concerns and customer service. ...
- Jan 09
Simi Valley, CA, 93065
... FDA audits and in providing responses to process related questions Eli Lilly and Company (Indianapolis, IN) 2000-2015 Chemical Process Research and Development: Consultant Chemist Conducted API process research and development for multiple projects. ...
- Jan 03