| Resume alert | Resumes 41 - 50 of 553 |
Project Management Machine Tool
Irvine, CA
... Validation, risk-based CSV/SDLC per FDA 21 CFR Part 11, ISO 14971, IEC 62304, -62366, ISPE GAMP, ICH Q9, ASTM E2500, IVDR. Data Integrity compliance, GxP assessment, create policy/SOP/template per 2018 FDA, UK-MHRA, EU Annex 11, ISPE, and ALCOA+. ... - Jan 06
... Validation, risk-based CSV/SDLC per FDA 21 CFR Part 11, ISO 14971, IEC 62304, -62366, ISPE GAMP, ICH Q9, ASTM E2500, IVDR. Data Integrity compliance, GxP assessment, create policy/SOP/template per 2018 FDA, UK-MHRA, EU Annex 11, ISPE, and ALCOA+. ... - Jan 06
Technical Writer
Huntington Beach, CA
... Lead Writer/Project Manager for business priority projects: o700 Series pumps, Guardian sensor and transmitters, and Synergy/Simplera/Instinct sensor o670G Hybrid Closed Loop – received FDA approval in record time of 102 days o630G Canada – reduced ... - Jan 05
... Lead Writer/Project Manager for business priority projects: o700 Series pumps, Guardian sensor and transmitters, and Synergy/Simplera/Instinct sensor o670G Hybrid Closed Loop – received FDA approval in record time of 102 days o630G Canada – reduced ... - Jan 05
Research Associate Product Development
Irvine, CA
... •Proficiency in MS Word, Excel, and experience in cGMP, GLP and FDA regulations for biotech and pharmaceuticals. SKILLS •Experienced in HPLC, GC, AA, FTIR and Dissolution •Report technical writing, training •Proficiency in MS Word, Excel, Powerpoint ... - Jan 03
... •Proficiency in MS Word, Excel, and experience in cGMP, GLP and FDA regulations for biotech and pharmaceuticals. SKILLS •Experienced in HPLC, GC, AA, FTIR and Dissolution •Report technical writing, training •Proficiency in MS Word, Excel, Powerpoint ... - Jan 03
Sales Manager Regional
Dana Point, CA, 92629
... Successfully integrated a Patient Advocacy position into the Operations Team that improved patient outcomes Launched new FDA-approved drugs Soliris (for MG) and Radicava (for ALS) throughout Arizona and Nevada AVELLA SPECIALTY PHARMACY (ACQUIRED ... - 2023 Dec 31
... Successfully integrated a Patient Advocacy position into the Operations Team that improved patient outcomes Launched new FDA-approved drugs Soliris (for MG) and Radicava (for ALS) throughout Arizona and Nevada AVELLA SPECIALTY PHARMACY (ACQUIRED ... - 2023 Dec 31
Design Build Construction Superintendent
Pomona, CA
... developed and received FDA approval for CIPP liner for their potable water. • Supervised infrastructure rehabilitation projects for oilfields, including CCTV inspection down deep vertical well shafts, mainline and lateral cured-in-pace-pipe, and ... - 2023 Dec 24
... developed and received FDA approval for CIPP liner for their potable water. • Supervised infrastructure rehabilitation projects for oilfields, including CCTV inspection down deep vertical well shafts, mainline and lateral cured-in-pace-pipe, and ... - 2023 Dec 24
Medical Devices Product Development
Irvine, CA
... Excellent knowledge of FDA, GMP, and ISO 13485 & 9001. Verified and validated products and processes per CFR 21 FDA 820 regulations and ISO standards. Essential qualifications: Board Level Presentations, Concept to Commercialization Management, ... - 2023 Dec 12
... Excellent knowledge of FDA, GMP, and ISO 13485 & 9001. Verified and validated products and processes per CFR 21 FDA 820 regulations and ISO standards. Essential qualifications: Board Level Presentations, Concept to Commercialization Management, ... - 2023 Dec 12
Quality Assurance Customer Service
Fountain Valley, CA
... Customer Service/ Satisfaction 21 CFR Part 820, 211, 210,111, 110 / FDA/ CDPH/ cGMP Project Management External/ Internal audit expertise Resource Allocation and Administration Seeking advancement opportunities as a Quality Systems professional. ... - 2023 Dec 11
... Customer Service/ Satisfaction 21 CFR Part 820, 211, 210,111, 110 / FDA/ CDPH/ cGMP Project Management External/ Internal audit expertise Resource Allocation and Administration Seeking advancement opportunities as a Quality Systems professional. ... - 2023 Dec 11
Business Development Client Service
Orange, CA, 92866
... Bexa™ is a new, FDA-cleared 510(k) medical device that employs high resolution elastography to produce a map of abnormal breast tissues and masses. Addition of Bexa™ to a breast exam is quick, painless, radiation-free and produces immediate results. ... - 2023 Dec 11
... Bexa™ is a new, FDA-cleared 510(k) medical device that employs high resolution elastography to produce a map of abnormal breast tissues and masses. Addition of Bexa™ to a breast exam is quick, painless, radiation-free and produces immediate results. ... - 2023 Dec 11
Quality Engineer Principal
Huntington Beach, CA
... Statistical Process Control (SPC) EXPERIENCE BRIDGING CONSULTING LLC, Los Angeles, CA 2023-present Consultant Reviewing protocols for real time/accelerated aging, and Process Qualification (PQ) protocols for FDA submission by overseas vendor. ... - 2023 Dec 09
... Statistical Process Control (SPC) EXPERIENCE BRIDGING CONSULTING LLC, Los Angeles, CA 2023-present Consultant Reviewing protocols for real time/accelerated aging, and Process Qualification (PQ) protocols for FDA submission by overseas vendor. ... - 2023 Dec 09
Data Information .Net Core
Tustin, CA
... Developed and enforced software requirements management and allocation, software design and implementation, and V & V procedures and methodologies compliant with company Quality Manual standards and FDA Guidelines. Insured and enhanced the overall ... - 2023 Dec 06
... Developed and enforced software requirements management and allocation, software design and implementation, and V & V procedures and methodologies compliant with company Quality Manual standards and FDA Guidelines. Insured and enhanced the overall ... - 2023 Dec 06