Manufacturing Quality Assurance Scientist - Biotech Resume Search
Manufacturing Quality Assurance Scientist - Biotech Resume Search
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Manufacturing/Quality Assurance Scientist Resume


Desired Industry: Biotech SpiderID: 29226
Desired Job Location: San Marcos, California Date Posted: 10/20/2009
Type of Position: Full-Time Permanent Availability Date:
Desired Wage:
U.S. Work Authorization: Yes
Job Level: Experienced with over 2 years experience Willing to Travel: Yes, Less Than 25%
Highest Degree Attained: Bachelors Willing to Relocate: Yes


Objective:
A challenging position utilizing skills acquired in Quality Assurance and Manufacturing


Experience:
Adecco Employment Services, Carlsbad, CA (2007 – present)
*Contract employee at Beckman Coulter, Inc., supporting reagent manufacturing in the Special Chemistry Department (see Production Scientist below)
*Utilize knowledge and expertise with exclusive focus on the manufacture and delivery of high volume critical stock products, using focused urgency to avoid customer complaints and manual allocations

Beckman Coulter, Inc., Carlsbad, California (1986 – 2006)
Senior Quality Assurance Scientist (2004 – 2006)
*QA signature authority with primary responsibility for sixty-four products and secondary responsibility for fifty-eight additional products
*Provided product support through data review and assessment of non-conforming material dispositions, process validations, change orders, label reviews, Process Change Notifications, and FMEA risk assessments.
*Primarily interfaced with Development and Technical Operations personnel to resolve product issues
*Planned, coordinated and reported on real time stability studies to support product claims per FDA regulations (ISO 9001)
*Represented QA on Development, Current Business, Material Review Board, CAPA, and product/process improvement projects
*Participated on Customer Feedback Failure Investigation Teams
*Provided Quality Systems support through participation in the Internal Audit program

Production Scientist I (Group Lead), Special Chemistry Department (1998 – 2004)
*Managed all phases of production and troubleshooting of Special Chemistry system instruments and reagents
*Participated in departmental team hiring
*Provided guidance and direction to junior associates daily
*Directed new employee training and cross-training of current personnel
*Scheduled and coordinated lab activities/duties
*Utilized strong skills in leadership, communication, and troubleshooting in team environment
*Performed new product scale-up of pilot products
*Assisted in technical decisions and data analysis
*Ensured manufacturing and documentation was performed according to Good Manufacturing Practices (GMP’s) per FDA regulations
*Actively involved in Process Improvement Teams to improve work efficiencies
*Proficient in analytical instrumentation and Microsoft Office applications
*Working knowledge of AMAPS and Cycle Count principles

Associate Production Scientist, Special Chemistry Department (1994 – 1998)
Senior Formulations Technician, Special Chemistry Department (1989 – 1994)
Formulations Technician, Special Chemistry Department (1986 – 1989)


Education:
Bachelor of Science, Business Administration (High Technology Management), May 2003
California State University, San Marcos, California

Associate of Arts and Science, Engineering, December 1985.
Illinois Central College, East Peoria, Illinois


Skills:
• analytical instrumentation
• technical data review/analysis
• instrument and reagent troubleshooting
• team-oriented problem solving
• cross-functional team member
• leadership
• communication
• multi-tasking
• qualified trainer


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