Kimberly Harris

Background

About Kimberly Harris

Nearly 9 years of experience in the Pharmaceutical IndustryCo-Managed Internal QA Monthly System Audit process for BioLife Facilities.Experience with the following FDA regulations (Blood, Plasma, and Medical Devices Regulations): CFR 606, CFR 610, CFR 640, CFR 630, CFR 660, CFR 820, CFR 211, and 510K Submission process.Managed the Systemic Review of Internal Monthly System Audits for BLPS facilities. Procedure Writer for BioLife Standard Operating Procedures (SOPs) and protocols. Co-Managed Record Retention Process for BioLife/Baxalta Divisions for onsite and offsite storage. Facilitated and assisted in Internal and External Quality Systems Audits including FDA, EMA and Chinese FDA.Facilitated Operational and Technical training of Electronic Quality Management System known as Trackwise.Facilitated and supported strategic planning of Leadership and Technical Development for BioLife Center Leadership Teams.Provided support to newly promoted QMRs and QLTs at BLPS facilities through training assessments leadership development and inspection readiness.Managed 3 BioLife Plasma Facilities conducting center analysis, strategic planning and implementing systems to support business improvements. Provided Operational and Quality onsite Leadership and Technical Training to over 50% of all BioLife Plasma Facilities.Subject Matter Expert in Change Management, Lean Process, CAPA and Leadership Development.Provided support to the various divisions of BioLife for effective and efficient implementation of the Quality Management System and CAPA process. Lean Green Belt Certified with 6 years of experience.