Florian R. Sumedrea, Lssbb Email & Phone Number

Cleveland/Akron, Ohio Area

Managed the Quality Control group at the Ohio manufacturing site. Provided supervision, development, and performance management for 12 QC Engineers and QC Inspectors. Oversaw activities in three QC labs, including analytical and functional testing supporting Affymetrix Microarray Reagents, Molecular Biology, and Biochemical products ensuring correct and complete ISO documentation and specification adherence. Aligned QC testing with manufacturing, purchasing, and commercial operations strategy to balance inventory levels with commercial needs. Worked with Corrective and Preventive Action (CAPA) teams to investigate product performance issues and alleviate customer complaints. Performed internal audits, reviewed Nonconforming Material Reports (NCMR), and documented process deviations to ensure compliance against quality standards. Reviewed and approved document changes as a member of Change Control Board (CCB). Managed the design and construction of a new GeneChip QC lab to consolidate operations unit in one building; used Lean tools to improve lab efficiency and integrate QC labs in a single location; supervised new lab construction, moved and re-validated entire instrument fleet; completed project in-time and on-budget.Evaluated talent and assigned three effective group leads.Revised, measured, and analyzed QC group key performance indicators (KPI); consistently exceeded department goal of 92% first-time pass rate while maintaining target testing turnaround time.Implemented OOS investigation process which reduced OOS cycle time by 8 percent and brought site to full compliance with OOS guidance. Assisted in operations transition and site closure following acquisition; hosted transfer site QC team hands-on training; traveled to transfer site and conducted follow-up training session; coordinated QC labs packing, cleaning and closure.

Planned, prioritized and supervised activities in GeneChip QC lab at the Ohio manufacturing site. Managed the workload of three to six QC Engineers supporting functional testing of Affymetrix Microarray reagents product lines. Completed the successful transfer of QC operations from California to Ohio and supported implementation of ISO 13485.Learned, performed and trained functional assays of Microarray reagents. Reviewed, coordinated, and executed reagent stability studies. Participated in extensive product failures investigations as member of CAPA teams. Worked with various cross-functional teams to support new product introduction, improve standard operating procedures (SOP), and reduce testing redundancy. Conducted functional assays required for manufacturing process validation of IVD reagents.Established an effective training process and developed focused expertise groups within GeneChip QC lab; supported company-wide implementation of training software (LMS). Implemented lab/instruments maintenance protocol and schedule. Performed new instrument qualification (IQOQPQ).Created reports to track workload, testing schedule, and test progress; characterized GeneChip QC lab workload by measuring direct and indirect labor hours; developed capacity utilization strategy to control product realization time and reduce operating cost. Implemented consumable point-of-use (POU) and used Lean tools to streamline QC lab workflow.

Conducted wet chemistry, spectrometry, and physical property tests on incoming raw materials and Biochemical products. Reviewed test results and manufacturing documents to confirm accuracy and compliance with specifications. Prepared Certificates of Analysis, revised product specifications. Maintained and calibrated laboratory instruments to ensure proper performance. Managed lab inventory (reagents, standards, consumables).Designed and implemented sample tracking/testing status database for biochemical QC lab. Implemented OOS form and developed OOS database.

Bucharest, Romania

Conducted research and proposed treatment solutions to reduce industrial wastewater pollutants to acceptable levels according to governmental regulations. Conducted sampling and sample preservation, performed literature search to determine treatment options, executed and coordinated lab testing to characterize wastewater chemical load prior and post-treatment, and wrote reports.

Master Of Science - Ms, Environmental Science

Bachelor Of Science - Bs, Physical Chemistry