Quality Lab Associate III
Resume:
Amy R. Mayes
Camby, IN ****3
****.********.**@*****.***
Summary
A hardworking and dedicated biologist/microbiologist performing a variety of chemical, biological, or physical analyses on products and systems in support of a quality program, ensuring production of high quality sterile products. Employment Experience
Baxter Pharmaceutical Solutions 2002 - Current
Quality Laboratory Associate III
Served as interim supervisor for the department for 6 months
Assisted in managing the monitoring program for critical utilities at the facility, including WFI, Clean Steam, Compressed Gasses, incoming city water and Softened and Reverse Osmosis feedwater.
Represented the department as Subject Matter Expert for regulatory audits including FDA, TGA and EMA.
Provided Sterility Assurance support testing for equipment validations and performance qualifications which include BI transfer, CCIT UV analysis, Particle analysis, and Residual LSK-9 detection, Sodium Chlorine detection, spiking containers/closures with endotoxin, sodium chloride and microorganisms and Bacterial Endotoxin Testing of containers/closures.
Maintained data integrity and ensured compliance with SOPs, Good Laboratory Practices and Good Documentation Practices.
Initiated and authored laboratory investigation reports, NWA and sub-alert level trending reports.
Executed sampling and testing of utilities for routine monitoring, PQ and/or annual systems confirmations of several critical systems, including: o WFI loops and supporting water pre-treatment systems o Clean and Pure Steam Systems
o Nitrogen and Processed Compressed Air Systems.
o Test methods executed include: microbial (mesophile and coliform) water testing, endotoxin testing, total organic carbon, conductivity, chlorine content, hardness content, silica content, total particle count, moisture content, oil content, nitrogen identification, EP nitrates testing; Steam quality – dryness fraction, non-condensable gases and super heat.
Knowledge of instruments and software, including endotoxin readers (Cambrex), HIAC liquid particle counter (Pharmspec), UV-1700 (Pharmspec), conductivity meters, pH meters and Anatel portable TOC analyzers.
Maintained the overall sample flow process through value stream mapping, scheduling and sample plans. Integrated lean tools to improve the sampling process.
Proficient with BPLM TeamCenter, Crystal Reports, NWA Quality Analyst and Track Wise Team Access and SQL*LIMS.
Qualified for and maintained gowning access into aseptic areas.
Participated in rapid microbial method evaluations, including the IMD-A rapid microbiological air sampler, and initial evaluation of the IMD-W rapid microbiological water sampler.
Cross functionally trained with the Chemistry department testing finished product and stability samples for particulate analysis (sterile injections and lyophilized product).
Education
Colorado State University-Pueblo Graduated 1996
Pueblo Colorado
B.S. Biology
Skills and Qualifications
Computer literacy with Microsoft Office suite of products
Operational experience with analytical instrument software, including WinKQCL, and NWA.
Experience with enterprise software systems, including SQL*LIMS, TrackWise, Qumas and BPLM.
Completed MALDI Biotyper Basic Operator Training References
Christy Butcher, QCCS Laboratory Supervisor. 812-***-**** Stacey Humerickhouse, CAPA Administration Supervisor. 812-***-**** Tina Agnew, Quality Manager I. 812-***-****
Daniel Hrnciar, Research Scientist I. 773-***-****
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