Midura_Resume
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Paul Midura has over 10 years of experience in quality engineering and healthcare. He has a B.S. in biomedical engineering from Arizona State University and certifications in pharmacy technician, ISO 13485 internal auditor, and FDA CFR 820. His experience includes quality engineering roles at Auer Precision and C.R. Bard where he performed risk management, developed manufacturing and inspection procedures, and updated design history files. He also has experience in pharmacy and healthcare as a senior intervention specialist, supervising pharmacy technician, and account manager.
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Ronald Preibis has over 17 years of experience in the biotech field, including extensive experience in all aspects of cell culture and purification. He has worked in manufacturing roles at several biotech companies, leading teams and supervising processes. His experience includes process development, cGMP manufacturing, analytical testing, documentation, and ensuring regulatory compliance. He is pursuing additional education in life sciences and biomedical laboratory sciences.Tandler Resume August 2015
Tandler Resume August 2015Robert Tandler
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Robert Tandler has over 25 years of experience in engineering consulting, project management, and product development for dental and medical device companies. He has extensive experience in 3D modeling, prototype development, manufacturing process development, regulatory compliance, and product launch. Currently he provides engineering consulting services for several companies involving product design, intellectual property negotiation, and strategic marketing.Cindy See Resume Sept 2016
Cindy See Resume Sept 2016Cindy See
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This document is a resume for Yon H. (Cindy) See. It summarizes her experience in supply chain management, procurement, and medical assisting roles over 20 years. She has extensive experience managing suppliers and developing procurement processes for healthcare companies. Currently, she works as a medical assistant at Duke Health, monitoring patients and assisting medical professionals. She also has project management and administrative experience from her time at IBM.Paul E Schafer Resume_9-9-2016
Paul E Schafer Resume_9-9-2016Paul E Schafer
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Paul E Schafer is a regulatory affairs specialist with over 5 years of experience in an ISO 13485 medical device manufacturing facility. He is looking to leverage his knowledge and experience in a role as a regulatory affairs specialist. His experience includes coordinating international device registration, managing complaint information, and facilitating regulatory support. He also has experience in quality roles such as document review, quality training management, and filling in as document control.CV-FORMAT Stein Steven 
CV-FORMAT Stein Steven Steven Stein
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This document provides a summary of Steven Stein's career experience and qualifications. He has over 50 years of experience in roles such as sales, service, operations management, and customer support within the manufacturing and logistics industries. His background includes extensive experience implementing quality management systems and obtaining product certifications for medical devices and analytical instruments.Eva Harding Resume_2015
Eva Harding Resume_2015Eva Harding
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Eva Harding has over 20 years of experience in the medical device industry, primarily focused on quality engineering roles at Abbott Vascular. She has supported new product development programs from design controls through regulatory submissions. Her experience includes risk assessment, design validation, human factors engineering, and submissions for CE marking and US approval. She is looking to expand her career into a leadership role where she can help meet and exceed corporate goals.AWR resume
AWR resumeAnthony Ross
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Anthony Ross is seeking a position where he can apply his knowledge and skills gained through years of experience in analytical chemistry and quality roles in pharmaceutical and medical device companies. He has extensive experience in analytical testing, writing and reviewing technical documents, validation, and ensuring compliance with cGMP and GLP regulations. Ross has over 20 years of experience in analytical chemistry roles, most recently as an Analytical Technologist at Dow Chemical where he performs testing, updates procedures, assists with validations, and trains personnel.Hanife Akin -updated
Hanife Akin -updatedHanife Akin
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Hanife Akin has over 15 years of experience in pharmaceutical manufacturing operations and leadership. She currently serves as Senior Director of Pharmaceutical Manufacturing at Stason Pharmaceuticals, where she oversees manufacturing, technical operations, and other departments. Previously, she held roles with increasing responsibility at other pharmaceutical companies, managing projects, process improvement initiatives, and validation activities. Akin has expertise in various manufacturing processes and dosage forms. She is a skilled leader and problem solver with strengths in project management, team building, and strategic planning.Melissa CV
Melissa CVMelissa Allen
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Melissa Allen has over 15 years of experience in veterinary medicine and animal health industries. She has worked as a registered veterinary technician providing customer service and technical support to veterinarians. Her experience includes managing adverse event reporting, performing pharmacovigilance reviews, and supporting marketing initiatives. Allen has extensive skills in Microsoft Office, databases, and laboratory equipment. She is a member of NAVTA and holds certifications in veterinary technology and laboratory animal techniques.JANELLE HEPPES RESUME
JANELLE HEPPES RESUMEJanelle Heppes
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Janelle Heppes is seeking a position as a Quality Control Laboratory Supervisor. She has over 13 years of experience in this role at 3M, where she supervised chemists, led daily lab operations, and ensured on-time testing. Some of her accomplishments include receiving safety awards, product approvals from the FDA, cost savings initiatives, and process improvements. She is skilled in leadership, collaboration, execution, developing others, and acting with integrity.Pfizer Sr. QC Scientist
Pfizer Sr. QC ScientistMaleeka Kazmi - Catalyst - Results Driven - PM Process Eng. Analytical Lab.Troubleshooting Expert
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Maleeka Kazmi has over 10 years of experience in quality control and analytical testing for the pharmaceutical industry. She has a strong background in analytical techniques like HPLC, GC, and UV/Vis and experience with method development, validation and technology troubleshooting. Currently she works as a quality control scientist at Pfizer performing testing, audits and continuous improvement projects.Midura_Resume
- 1. PAUL J. MIDURA 3771 EAST JASPER DRIVE – GILBERT, ARIZONA – 85296 MR.PAUL2012@GMAIL.COM – 480.275.0752 OVERVIEW Detail–oriented technical professionalwith B.S. in Bioengineering; FDA CFR 820; ISO 13485; cGMP; DFMEA and PFMEA risk management activities; Design History File experience; Sales-engineering accomplishments; MiniTab, Infinity QS SPC, Excel, Outlook, PowerPoint, Visio and Word software proficiency; Cross-functional team mindset; Clean-room manufacturing experience; Gauge R&R studies EDUCATION  Arizona State University Biomedical Engineering,B.S.E. – Tempe, Arizona (May 2008) CERTIFICATIONS  Certified Pharmacy Technician, CPhT Arizona State Board of Pharmacy – T022994 (Valid through October 31, 2016) Pharmacy Technician Certification Board (PTCB) – 10085933 (Valid through July 31,2017)  ISO 13485 Internal Auditor: Medical Device Quality Management Systems British StandardsInstitution (October2014) PROFESSIONAL EXPERIENCE Quality Engineer – Auer Precision – Mesa, Arizona (August 2014 – October 2014)  Participated in client meetings outlining manufacturing needs and production costs  ISO 13485:2003 Internal Auditor training and coursework  Wrote control plans for large scale manufacture of customer designed medical devices  Wrote operational qualifications for stamping, slitting, and converting systems  Utilized SPC software for performance analysis of new equipment vs. current processes  Active in manufacturing operations in an effort to identify equipment settings for production Quality Engineer – C. R. Bard – Tempe, Arizona (December 2011 – June 2013)  Risk-management activities for design reviews; DFMEA and PFMEA  Utilized FDA design controls in new product development activities  Wrote and executed IQs, OQs, and PQs for manufacturing and inspection equipment  Updated Design History Files (DHF) for stent graft and angioplasty product lines  Wrote and executed manufacturing procedures,inspection procedures, and Gauge R&R studies  Utilized complaint files of marketed products to identify potential origin of device/design failure Senior Intervention Specialist – Express Scripts – Tempe, Arizona (December 2010 – December 2011)  Managed resolution of rejected insurance claims for the Department of Defense  Participated in efforts to minimize DPMO in prescription processing  Analysis and review of work orders, patient profiles, and processing errors Supervising Pharmacy Technician – Bashas’ – Tempe, Arizona (January 2010 – December 2010)  Trained pharmacy technicians for multiple locations  Resolved rejected insurance claims for retail operations  Managed medication inventory,returns, expiration, and forecasting for business outlook Account Manager – Lost Sheep Coffee Company – New Orleans, Louisiana (October 2008 – January 2010)  Business to business sales of whole bean coffee to local cafes, restaurants,and grocery/retail locations  Initiated promotional efforts for active sampling at grocery stores,farmer’s markets, and restaurants  Responsible for price negotiation, whole-bean production estimates, and product distribution