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Click here or scroll down to respond to this candidateCandidate's Name
EMAIL AVAILABLE PHONE NUMBER AVAILABLELINKEDIN LINK AVAILABLE Topeka, KS Street Address
Accomplished and detail-oriented professional with extensive experience in supporting drug manufacturing programs. Proficient in collaborating with Executive Leadership to develop long-range strategic plans while delivering operational efficiency. Proven ability to make real-time decisions and resolve issues quickly. Expert in identifying process and system improvement opportunities by monitoring existing metrics, analyzing data, and partnering with internal teams to positively impact results. Adept at complying with cGMP, identifying and implementing best practices, and training new teams on new projects.Areas of ExpertiseProject/Program ManagementFinancial ReportingProcedure & Policy AdherenceRegulatory ComplianceContinual Process ImprovementsTeam Leadership & DevelopmentQuality Auditing ProcessesOversee Training & PerformanceRisk Detection and ManagementProfessional ExperienceDaVita Kidney Care Topeka, KS 2022 currentOperations Manager (06/22 current)Responsible for monthly monitoring of financial results, variance reporting and action plans to meet established budget objectives Maintain Quality Assurance Programs by ensuring compliance with policies and procedures in accordance with State and Federal Regulations for patient care and services (HIPAA, CMS, OSHA, or other governing agencies). Participate in development and revision of policies and procedures with Regional Management and Medical Director to ensure consistent, efficient and safe treatment delivery.Received highest achievement rating in Operational Readiness Assessment.Improved Quality Index score by 166% within two months of facility acquisition.Grifols, Biomat USA Inc., Topeka, KS 2006 2022Center Manager (2009 2022)Oversee compliant collection of source plasma for manufacturing of medications. Perform internal quality audits and monitor regulatory compliance. Set, enforce, and optimize internal policies and company/customer standards to maintain efficiency and responsiveness to demands. Strategically plan methods to achieve operational goals and targets. Represent company with outside vendors, customers, and auditors.Successfully opened new plasma donation center meeting FDA, OSHA, cGMP, and EU guidelines while managing two locations simultaneously for six months.Recognized as a leader in the region for maintaining quality KPI scores at 92% in 2021.Lowered return donor cycle times to 83 minutes on average.Maximized efficiency by coaching and mentoring 50+ personnel on drug manufacturing, industry practices, and company processes/procedures.Efficiently handled overall program, resulting in increasing production levels.Managed center budget of $1M+ as well as monitored and evaluated all financial operations to assess performance and develop targeted improvements and implement changes resulting in meeting financial, efficiency, and quality goals.Quality Supervisor (2006 2009)Uncovered operational issues and developed corrective action plans using root cause analysis. Directed and monitored quality program to ensure compliance of plasma collections. Observed and analyzed employees and processes to ensure compliance with safety and quality standards. Maintained knowledge of institutional policies and regulatory compliance. Developed monthly reports showing inspections and improvements.Headed audits, including FDA, Corporate, IQPP, CLIA, and EMA audits and led teams to fully investigate quality control processes and root out deficiencies.Assured all plasma collections meet specifications and requirements of SOP, following cGMP, OSHA, and FDA regulations.Additional ExperiencePhlebotomy Lead/Phlebotomist, Grifols, Biomat USA Inc., Topeka, KSEducationBachelors of Science in Biology Cum LaudeWashburn University, Topeka, KSCoursework: Organic Chemistry, Immunology, and GeneticsAffiliationsMember, Tri-Beta Biological Society |
