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Yyyyyy x. yyyyyy

0000 xxxxxx xxxx , xxxx , xxxxx 00000

Phone: (xxx-xxx-xxxx abc@xyz.com

 

Dedicated Sterilization Microbiologist eager to contribute exemplary operations leadership and project management talents toward supporting a dynamic organization in achieving goals and objectives.

 

Profile

 

         Proven success in planning, coordination, and management of sterilization projects in strict compliance with industry standards and quality control guidelines.

         Offer 10 years of experience in research and development for medical device industry with proficiency in directing and performing powder filling, labeling, packaging, and sterilization operations.

         Advanced understanding of FDA and ISO requirements for implantable medical devices.

         Expert in wide range of sterilization processes, bio-burden control, and pyrogen testing.

         Consistently adhere to specific standard operating procedures (SOPs) and work instructions (WIs).

         Substantial strengths in use of state-of-the-art laboratory equipment and instrumentation.

         Structured, systematic, and highly skilled at driving cooperative efforts among peers and management.

         Well-versed in Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and lab safety rules and regulations including hazardous materials management, OSHA criteria and chemical hygiene policies.

 

Professional Experience

 

Self-employed, New Brighton, MN,  2007 to Present

Microbiological / Sterilization Consultant 

  • Perform broad-scope gamma irradiation and e-beam sterilization studies, biocompatibility  testing, pre-clinical animal testing, Notified Body (NB) quality audits, and microbiology assessments.
  • Apply strong attention to detail and accuracy in conducting supplier audits, establishing protocols, and preparing SOPs and WIs for projects and validation activities.

 

Boston Scientific Corporation, Minneapolis, MN,  2006

Senior Sterilization Microbiologist

  • Served as key member of process validation team in Department of Corporate Sterilization Services.
  • Completed and documented EtO (Ethylene Oxide) validations at contract sterilization vendors.

 

Medafor, Inc., Minneapolis, MN, 2000 to 2006

Vice President, Operations

  • Directed daily operations for medical device product development encompassing powder filling, packaging, labeling, and sterilization.
  • Drove cohesive and collaborative efforts among cross-functional teams to ensure compliance with clinical and regulatory requirements, while effectively optimizing productivity and quality control.
  • Spearheaded planning, design and management of technical projects from concept to timely and budget-compliant completion.

 

Senior Sterilization Microbiologist

  • Provided hands-on leadership for production of safe and efficacious class II/III sterile medical devices.
  • Executed sterilization validation procedures including quarterly dose audits and pyrogen, bio-burden, and environmental testing.

 

Continued

 

 

Professional Experience continued                                                             Yyyyyy x. yyyyyy C Page 2 of 2

 

  • Conducted in vivo and in vitro animal and biocompatibility studies and resourcefully implemented histopathology processes.
  • Efficiently performed powder filling, labeling, packaging, and sterilization while serving as key technical resource and mentor to marketing, regulatory and clinical departments/personnel.
  • Diligently completed domestic and foreign vendor audits in adherence to both FDA guidelines and NB requirements for CE marking.
  • Played an integral role in FDA Quality System Regulation (QSR) audit and NB microbiological assessment audit for CE marking.
  • Contributed extensive technical acumen and industry background toward authoring sections of Premarket Approval Application (PMA), technical files for CE marketing, and 510(k) applications for usage as a topical device.

 

Surmodics, Inc., Minneapolis, MN, 1998 to 1999

Research Microbiologist

  • Proactively supported product development activities for in-dwelling catheters and stents by researching and testing antimicrobial coatings.

 

Medivators, Inc., Minneapolis, MN, 1996 to 1998

Research Microbiologist

  • Conducted comprehensive research and development efforts for new disinfectant products used in sanitizing endoscopes.

 

Prior Background:

 

Sales and Technical Service Manager C Midwest, Idetek, Inc., Sunnyvale, CA

Microbiologist / Product Development Specialist, BallistiVet, Inc., St. Paul, MN

Microbiologist, University of Minnesota College of Veterinary Medicine, St. Paul, MN

 

Education

 

Master of Arts in Biological Sciences, University of Nebraska, Omaha, NE

 

Bachelor of Science in Biological Sciences, St. Cloud State University, St. Cloud, MN

 

Professional Development

Biocompatibility Testing C WuXiAppTec Laboratories

Industrial Sterilization for Medical Devices C AAMI

Current Issues in Medical Device Sterilization C STERIS/Isomedix

ISO 9001:0000 xxxxxx xxxx , xxxx , xxxxx 00000 C BSI

Good Laboratory Practices for Technical Staff C University of Minnesota/Pacific Rim Consulting

Design Controls: How to Comply with GMP and ISO Requirements C Biological Process Technology Institute at the Institute of Minnesota

Microbiological Quality Assurance for Pharmaceuticals C American Society of Microbiology

GMP s for Pharmaceutical and Allied Health Industries; Industrial Sterilization / Microbiological Quality Control; Clean Room Technology C Center for Professional Advancement

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