Quality Assurance Control
Resume:
Heather L. Gingerich
************@*****.***
Ft. Wayne, IN 46805
PROFESSIONAL
SUMMARY
Innovative, organized, and detail-oriented Quality Assurance and Safety Professional with over 9 years of experience in the Biotech, Environmental and Agricultural Testing Industry and the Non-Profit Sector. Extensive experience working in National, Federal and State regulated environments: GMP, GLP, ISO, FDA, EPA, IOSHA, CAL OSHA & NELAP.
SKILLS
Specialized in research, experimental design, data analysis, developing and leading collaborative efforts, streamlining processes, employee training, team building, and theory-based social innovation
Authored and initiated the revision of safety training, training manuals, flow charts, organizational charts, standard operating procedures, pilot studies, verification protocols, reports, summaries and certificates of analysis
Proficient in Microsoft Word, Power Point and Excel
Excellent verbal and written communication
Motivated team player also accustomed to working independently
Operational skills in HPLC, peptide synthesis, spectrophotometric analysis and lyophilization.
EXPERIENCE
Harvest Mission International, Inc., Fort Wayne, IN November 2009 – September 2012
Community Development Strategist & Community Coordinator
Reported directly to and assisted the Chief Executive Officer and Chief Financial Officer
Strategic development of organizational mission and direction
Interpreted and translated organizational concepts and ideas for public
Assisted in the initiation of and maintenance of several collaborative efforts between various non-profit organizations, city and county officials
Conducted new initiatives and assisted in the development of several pilot studies
Researched theories behind all projects and initiatives
A & L Great Lakes Laboratories, Fort Wayne, IN June 2008 – December 2011
Quality Assurance Coordinator & Safety Officer
Reported directly to and assisted the Laboratory Quality/ Safety / IT Manager
Gained and maintained regulatory compliance through the development of relationships within and between Laboratory Departments
Conducted mandatory and research based audits for both Quality Assurance and Safety purposes
Edited and authored several Standard Operating Procedures
Updated and initiated new Respirator Program and yearly fit-test schedule
Developed laboratory wide instrument calibration and proficiency test schedule
Conducted time sensitive proficiency tests in order to maintain laboratory certifications
Updated and revised entire Safety Program
Applied Biotech, Inc., San Diego, CA August 2005 – December 2006
Product Support Chemist I / Quality Control Technician
Reported directly to the Lead Chemist
Developed a strong working relationship and improved communication among Product Support Team and Quality Control Team members in order to create a more efficient and productive laboratory
Specialized in conducting research and optimizing immuno-assays
Authored several verification protocols and revised standard operating procedures
Collaborated with other scientists to conduct several sensitivity, precision design verification, stability and clinical studies
Researched infectious diseases and various hormones
Validated, programmed, calibrated and operated instrumentation
Maintained cGMP and Safety compliance, conducted investigational testing, and handled non-conforming materials according to standard operating procedure
Strengthened Quality Control team by devising more efficient testing methods
Genebact Biotechnologies, Inc. August 2003 to December 2003
Research Assistant
Reported directly to and assisted the Chief Executive Officer and Lead Scientist
Assisted in the production of and researched suitable applications for ICPF (Immune Cell Potentiating Factor)
Performed HPLC analysis, peptide synthesis, the lyophilization of ICPF and instrument maintenance
Prepared power point presentations and reviewed protocols
Kept lab notebooks in accordance with GLP for research and manufacturing laboratories
Conducted pilot stability studies, temperature stability studies and Quality Assurance audits
CANJI, Inc. December 2002 to June 2003
Receiving Manager & cGMP Inspector
Quarantined and distributed hazardous biological, chemical and radioactive substances
Implemented new receiver safety protocols and developed receiver training manuals
Packaged and shipped hazardous materials
Performed bi-monthly laboratory safety inspections, quarantined, inspected and released cGMP materials
Inspected and monitored clean room
EDUCATION
Biology Major at South Western College; Chula Vista California
Biology Major, 2003
Associates of the Arts; Ohio University, Athens Ohio 1996
CERTIFICATIONS
Biotechnology Course of the Regional Occupation Program; Chula Vista California 2002-2003
ADDITIONAL
EXPERIENCE
Mission Team Member, 2009-Current
Dermatological Nurse, 2007 - 2008
Group home foster parent, 2004-2005
Teacher’s Aide, Summer 2005
Assistant to President of Proactive Environmental, Summer 2003
Martial Arts Instructor, 2000-2002
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