Medical Device Manufacturing, Quality Assurance, Regulatory
Resume:
Kyle Onjukka *** S Jupiter Rd., Apt. ***,
Allen, TX 75002
Cell: 971-***-****
Email: ac1kke@r.postjobfree.com
Objective:
A long term challenging position that uses my organizational, solution orientated, administrative skills with a company that provides advancement and learning opportunities.
Qualifications:
Motivated self-starter. Very organized and detail orientated. I am excellent with computer systems, a fast learner and loyal employee. Efficient in maintaining a clean and organized work space, with attention to detail. Proficient in lab procedures related to analytic chemistry for environmental compliance and FDA and ISO compliance.
Education:
Bachelor of Science: Biology, Microbiology, Portland State University, August 2005
Work Experience
Regulatory and Quality Assurance Associate Primal Health 10-2016 to 7-2017 Allen, TX
Responsible for Document Control document change control operations
Performing cGMP and environment for dietary supplement distribution company
Quality Assurance SOP writing and review
Assisting in document management procedure development
Distribution control for dietary supplements
FTC and FDA document control for dietary supplement company
Reviewing and developing employee training protocols
Ensuring FDA compliance for released dietary supplement products
Performing Document Control operational logistics
Review of Clinical Trials for Structure Function Claims
21 CFR 111 compliance for GMP practices for holding and distribution of dietary supplements and contract manufacturing of dietary supplements
Master Manufacturing Record review and Batch Production Record review of contract manufacturer’s dietary supplement manufacturing records
Medical Device Coordinator Nephron Pharmaceuticals 12-2015 to 07-2016 Columbia, SC
Responsible for Document Control document change control operations
Responsible for FDA compliance in Medical Device Manufacturing
Developing medical device manufacturing and management
ISO 13485 compliance reviews with managers and ISO auditors for development of product
Responsible for personnel training paperwork maintenance
Responsible for document management maintenance
Lead weekly Quality Assurance meetings with owner, COO, Project Manager, and Sales
Developed SharePoint based document control infrastructure
Human Study Clinical Trials and reports for medical device approval
21 CFR 210 and 21 CFR 211 compliance for nebulized drug product
21 CFR 820 compliance for medical device manufacturing with nebulizer
QA Systems Specialist Oligos Etc., Inc. 08-2014 to 09-2015 Wilsonville, OR
Responsible for Document Control document change control operations
Performing cGMP and ASR product Quality Assurance document review operations
Assisting in document management procedure development
Design control for nebulizer project
Risk Control for nebulizer project
Reviewing and developing employee training protocols
Ensuring FDA compliance for released products
21 CFR 210 and 21 CFR 211 compliance for cGMP manufacturing processes with synthetic RNA and DNA manufacturing
Performing Document Control operational logistics
Clinical Trials design and reporting for in-vitro diagnostic studies
21 CFR 820 compliance review, and process development for synthesized DNA/RNA used for in-vitro diagnostic (IVD) during weekly quality meetings with company owner and area supervisors
AO Manufacturing Technician Genentech 12-2013 to 06-2014 Hillsboro, OR
Performing material handing for Aseptic Operations in the plant
Assisting in cleaning, set-up, sterilization, and disassembly of processing equipment
Performing preparation of sterile manufacturing components
21 CFR 211 and 21 CFR 210 compliance for manufactured pharmaceutical products
Performing cGMP documentation throughout manufacturing operations
Utilizing software applications (SAP and MES systems) throughout manufacturing processes
Environmental Safety Technician Acumed 01-2009 to 08-2013 Hillsboro, OR
Responsible for safety training classes and safety compliance in two manufacturing plants for all employees. Utilized MS Office, Windows XP/NT, PowerPoint and Presentation.
Initiated OSHA and EPA programs in the plants, and was able to get both facilities certified. Maintained the compliance with both plants.
Risk Control for orthopedic implant manufacturing.
21 CFR 820 compliance review with process and product engineers for medical device manufacturing and possible facility issues in root cause analysis and out of specification investigations and reviews
ISO 13485 compliance reviews with managers and ISO auditors annually
Was certified in a 40 hour Hazardous waste operations training, and implemented the plants hazardous waste management program and waste stream analysis.
Conducted forklift training classes, building management programs, and supervised contract labor for large projects, such as the Heating Ventilation Air Conditioning control, Fire Safety, and compliance inspection programs
Material handling and disposal, including 55 gallon drums containing hazardous waste, and gas cylinders.
Annual 29 CFR 1910 compliance review for facilities and procedures with Quality Managers
Lab Technician Test America Inc., 7-2007 to 12-2008 Beaverton, OR
Facilitated analysis on transformer oil for presence of PCB, as a beginning oil quality analyst.
Tested for volatile dissolved gas.
Tested for power factor and other varied oil quality tests.
Advanced to Hazardous waste specialist, before taking on the position at Acumed.
Lab Technician /Aid/Productions Specialist
Various lab facilities in Portland area. (specific company information available upon request).
August 2005-July 2007.
Was responsible for performing gel and chromatography analysis.
Lead in testing for Bovine Viral Diarrhea disease utilizing RNAase-free technique for real time-PCR/Learned to operate HPLC and GC machines.
Organized and prepared supplies for testing to keep tests on or ahead of schedule.
References:
Upon Request
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