Janine Cisneros Email and Phone Number

Collaborated with manufacturing and laboratory management to ensure regulatory manufacturingcompliance by reviewing batch records, conducting quality checks, and analyzing testing material data.Lead troubleshooting efforts for manufacturing and QC laboratory investigations, generating process updates consistent with Quality Management Principles.Conducted quality reviews of manufacturing and laboratory investigations, GMP and Quality Systemissues, non-conforming materials, and CAPA as needed.Generated deviations and CAPAs to enhance compliance and prevent recurrence of deviations.Established and maintained procedures in accordance with ISO 15189 to ensure data integrity andcompliance. Proposed and established changes to systems, procedures, and methods.Effectively managed multitasking responsibilities and addressed Quality issues and reported non-compliant findings to Laboratory and Technical Directors promptly.Prepared and submitted to management monthly reports tracking assay control trends.Contributed to ISO 13485 certification through developing new procedures and writing SOP’s forreviewing and validating manufactured materials.Demonstrated strong analytical and problem-solving skills, with a focus on quality assurance and riskmanagement.Represented the QC Department in new assay validations. Built analysis tools for new testing materials, performed the lengthy process to input new reagents into internal LIMS, and edited R&D procedures for clarity in manufacturing.

Supported testing of 3.4 million patients annually by providing uninterrupted stream of reagents used in 100+ lab developed tests by manufacturing MSD/Elisa Plates, Labels, Cell Lysate, Calibrators, Controls and Buffers.Used 5S technique to organize reagent storage locations to improve usability within department andpreserve drug materials within FDA and DEA compliance.Streamlined the QC manufacturing process by building a data log that houses critical instructions whichreduced overall manufacturing rejects, reworks and indicated adequate lead times so no deadlines were missed or assays delayed.Used proper PPE and aseptic technique to maintain and pass K-562 cell line. Performed technicalprocedure for cell protein S35 radioactive Methionine labeling for laboratory Myositis test.Worked and collaborated in cross functional teams with Research and Development, Manufacturing, and Technical Directors to troubleshoot and improve process in a fast pace, dynamic team setting.

Processed 2000+ specimens per day on multiple, high complexity analyzers in Clinical Chemistry.Specialized in highly specific and sensitive endocrine testing services certified by CAP, CLIA, and ISO.Designated as Department Trainer by management. Trained new staff on specialized testing equipment, computer systems, and performed annual competency assessments.Performed instrument carry-over testing to prevent inaccurate results of patient samples. Documented and performed preventive maintenance, calibration, troubleshooting, and repairs on instruments.Conducted departmental internal review and inspections of lab documentation and work areas cleanliness in preparation of ISO, CAP/CLIA audits.Performed Performance Qualification test runs on new analyzers to ensured incoming equipment meets all acceptable performance criteria.