Kelcey Gamble Email & Phone Number

Charlotte, Nc, Us

Austin, Texas, Us

As a QC Operations Trainer I support the laboratory personnel to maintain proficiency and competency of standard operating procedures in the Operations Department. I work closely with other department managers to ensure company and team goals are met. I am proficient in qualitay assurance of CLIA, CAP, NY, and FDA regulations and support the laboratory in maintaining compliance with internal audits, tracking competencies and training. I also manage and approve NCR, ACA and CAPA quality events. Proficient in technical writing creating and formatting Standard Operating Procedures (SOP), Work Instructions (WI) and forms. I worked as part of the implementation team in revamping the entire training and LMS management; transitioning from Success Factors to Cornerstone and Dot Compliance. Worked towards automating all processes from complete manual processes to efficiently track and maintain all training, license, and competency deadlines. I personally revamped the continuing education program to parallel CLIA/CAP regulations as well as conform to all NYS and FDA standards. My current project utiliizes Adobe Captivate to revamp and create training modules for the cornerstone and Dot Compliance platforms that are geared towards more interactive adult learning and retention.

Tempe, Arizona, Us

Assists with training laboratory employees, evaluating staff competency, and completing training documentation. Performs automated and manual testing on donor blood samples to ensure the safety, potency and purity of the blood supply as required by the regulatory agencies. Coordinates and supervises training assisting in scheduling, planning, designing, developing, implementing, and measuring effectiveness of technical training and education programs.*Instrumental in the implementation of the NEO Iris from the Galileo.*Part of the implementation Team for COVID antibody screening from workflow to training the use of Ortho Diagnostics VITROS XT7600 / VITROS 3600 analyzers. *Worked as a part of the implementation team for the Ortho PROVUE.

Tempe, Arizona, Us

Performs testing on blood donor samples. Proficient at the use of the Immucor NEO Iris instrument for IAT and ABO/Rh testing; Beckman Coulter PK7300 for ABO/Rh, Syphilis and CMV, SickleDex for HgbS testing; Immucor Manual ABO/Rh testing; and Stratec Gemini for Human leukocyte antigen (HLA) screening. Beckman Coulter AU680 Ferritin/ Triglycerides/ Cholesterol screening. Immucor Manual Antibody Titer Testing. Understand and comply with applicable federal and state regulations, AABB Standards, and ARCBS directives pertaining to blood banking and safety. Adhere to quality assurance procedures and current Good Manufacturing Practices.