1. Alice K Gray MT BS Biology (ASCP)
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21567 South Centennial Rd.
Jerseyville, IL 62052 (314) 728-1552
Objective: A position at a state of the art company which will support my aspirations to expand my
knowledge and utilize my strengths as a leader with extensive experience in microbiology,
quality and, research.
QUALIFICATIONS OVERVIEW
Eight (8) years of experience in microbiology , including four (4) years in lead/supervisory positions, in both the clinical and
manufacturing settings acquiring a wide range of experience and knowledge with applying GMP requirements, reviewing and
troubleshooting Quality Control data, drafting and approving quality documents (non-conformities/deviation reports, procedures,
waivers, etc.), conducting root cause analysis, authoring and executing scientific studies and process validations, designing and
executing experiments, performing and interpreting clinical and environmental identifications and susceptibility tests utilizing
multiple technologies (API, VITEK, Microscan, Kirby Bauer, etc.), encouraging and developing strong teams, recommending and
conducting process improvements, and participating in internal/external audits. Commended for being a thorough and quick
learner who is focuses on high quality, accuracy and timely completion of assigned responsibilities.
Employment:
2/2013- Present BioMerieux, Hazelwood MO
Industrialization,Scientist 2/2013 to 3/2016; Lead Microbiologist-Scientist 3/2016 to present
 Lead investigator into all QC lot performance issues. Investigations include
performing root cause analysis (utilizing tools such as fish bone diagrams and 5-
Whys) designing and performing experiments, determining what if any
preventative/corrective actions are needed and reviewing/updating risk analysis as
appropriate. Responsible for formalizing these findings in FDA auditable reports.
 Support the Quality Control department as the subject matter expert for the company
by reviewing any lot failures to exclude organism and/or testing issues to determine
disposition and ensure both the quality of the final released product and limit
financial loss.
 Member of numerous teams including the Material Review Board, and quality
robustness trending review board. As a participant on MRB, responsible for
reviewing and approving non-conformity material reports before the final disposition
of material.
 Recommended and implemented QC process improvements
o Modified QC procedures to align with current practices decreasing the total
number of QC performance related NCMRs per year by 30%.
 Liaison between Research and Development Department and Manufacturing.
Participate on numerous teams throughout new drug rounds and attendee for design
reviews throughout all stages of the development process. Author and execute
manufacturing process validations. Participate in investigations to determine cause of
any failures. Update all appropriate documentation as required by regulatory
agencies including risk analysis and device history files.
 Member of audit team, performing both internal and external supplier audits.
Experience with presenting and explaining data to FDA auditors. Designed, authored
and executed studies in response to audit findings. Experience as both a lead
investigator and team member on severalCAPAs created in response to findings.
 Daily use of manufacturing systems including trackwise and MES.

2.  Frequent use of Microsoft office tools including Excel, Word, PowerPoint and
Access.
1/2008-2/2013 Alton Memorial Hospital, Alton IL
12/2008-2/2013 Technical Coordinator, Microbiology and Point of Care Testing
1/2008-12/2008- Clinical Laboratory Scientist, Microbiology
Perform and oversee routine and stat microbiology testing. Responsibilities include
deciphering cultures and completing any required testing to identify and perform sensitivities
on isolated pathogens. Instrumentation includes Siemens Walkaway, and BD’s Bactec.
Supervisor responsibilities include overseeing and reviewing quality control and performing
monthly audits as part of a quality assurance program aimed at assuring the validity of both
microbiology and point of care testing. Also responsible for scheduling, writing and
reviewing procedures and making sure compliance is meant within numerous regulatory
agencies including CAP and JOCHOA.
8/2006- 1/2008 Anderson Hospital, Maryville IL
Medical Technologist, Generalist
Perform routine and stat hematology, chemistry, coag, urinalysis, and blood bank testing.
Responsibilities include evaluation of automated results and completion of any subsequent
testing, such as manual differentials, klehaur betkes and dilutions. Instrumentation includes
chemistry ECI and 5.1 analyzers, Advia 120 hematology analyzer, Stago coag analyzer and
gel testing for blood bank.
6/2005- 8/2006 St. John’s Mercy Medical Center, St. Louis MO
Medical Technologist, Blood Bank.
Perform type and cross match on patient samples and complete any additional testing such as
antibody identification, DAT or eluate testing. Issue blood products to hospital personnel,
thaw FFP, prepare pooled cryoprecipitate, pediatric aliquots and irradiate blood products.
Education: Bachelors ofScience in Biology, Medical Technology May 2005
Southern Illinois University, Edwardsville, IL
Graduated with Honors
Clinical School ofLaboratory Science June 2005
St. John’s Mercy Medical Center, St. Louis, MO
Received full scholarship for academic excellence
Certification: ASCP