Experience

Pacira BioSciences, Inc.

• United States
• Pharmaceutical Manufacturing
• 500 - 600 Employee

• Technology Partner for Quality, QC, R&D, and Manufacturing

  • Jan 2020 - Present

  United States

• Senior Laboratory Systems Analyst

  • Aug 2015 - Dec 2019

  La Jolla, California Acted as primary IT vendor/quality system manager for multiple laboratory/manufacturing/company software systems. I built relationships between IT and user groups. These quality systems included a large Agilent Openlab CDS, implementation/validation of Empower Enterprise CDS, two facilities and calibration management systems (RAM, and AMMS), the environmental monitoring system Lighthouse and two LIMS systems (LabWare and MODA). Openlab was having consistent usage errors. I analyzed the… Show more Acted as primary IT vendor/quality system manager for multiple laboratory/manufacturing/company software systems. I built relationships between IT and user groups. These quality systems included a large Agilent Openlab CDS, implementation/validation of Empower Enterprise CDS, two facilities and calibration management systems (RAM, and AMMS), the environmental monitoring system Lighthouse and two LIMS systems (LabWare and MODA). Openlab was having consistent usage errors. I analyzed the system, improved processes, and reduced error. For the LIMS systems, I was IT’s specialist and assisted in building processes/guided admins during two install/validation projects. For the facilities systems, I ran the projects to upgrade current v10 system to v12 which included new requirements and validated and cutover the company to a full validated RAM CMMS. I also upgraded/validated MasterControl QMS. I was responsible for IT Change control, procedure development and management as well as numerous other cross functional roles.



Genoptix, Inc.

• United States
• Hospitals and Health Care
• 1 - 100 Employee

• Senior LIMS Analyst

  • Jul 2012 - Aug 2015

  Carlsbad, CA Worked with a team to choose an all encompassing flexible Laboratory Information Management System (LIMS) from multiple vendors which would provide GxP compliance (21 cfr part 11) for the Genoptix/Novartis lab, obtained certification in Labvantage 6.0 Lab Admin/System Admin due to laboratory needs, developed this LIMS asset according to workflow knowledge and experience, participated in the development of all encompassing documentation for our GxP validation (IQ, OQ, PQ) of this system. This… Show more Worked with a team to choose an all encompassing flexible Laboratory Information Management System (LIMS) from multiple vendors which would provide GxP compliance (21 cfr part 11) for the Genoptix/Novartis lab, obtained certification in Labvantage 6.0 Lab Admin/System Admin due to laboratory needs, developed this LIMS asset according to workflow knowledge and experience, participated in the development of all encompassing documentation for our GxP validation (IQ, OQ, PQ) of this system. This work underwent auditing and passed with no issues. Took on the Clinical Data management and resulting side of the LIMS development and worked with multiple large pharma cross functional data management teams to provide specifically designed data structures which allow for increased compliance study wide.

• Scientist

  • Dec 2007 - Jul 2012

  Carlsbad, ca Participated in the building of a large multidisciplinary department (Flow, IHC, Molecular, Cytogenetic, and Solid Tumor) answering to multiple regulatory groups (CLIA, CAP, GXP, FDA, etc) while providing clinical trial results specific to client need, streamlined the department to smoothly develop and transfer assays and procedures into the onsite CLIA lab. Successfully validated assays for new CLIA/CAP licensure , participated many years in a validated environment, provided many GXP… Show more Participated in the building of a large multidisciplinary department (Flow, IHC, Molecular, Cytogenetic, and Solid Tumor) answering to multiple regulatory groups (CLIA, CAP, GXP, FDA, etc) while providing clinical trial results specific to client need, streamlined the department to smoothly develop and transfer assays and procedures into the onsite CLIA lab. Successfully validated assays for new CLIA/CAP licensure , participated many years in a validated environment, provided many GXP phase I-IV data cleanses and data transfers with full documentation, Managed the development and validation of multiple timeline sensitive assays for exterior Biopharma/Pharmaceutical clients, developed and ran study-specific flow and IHC assays (Breast, Prostate Lung and Cell line) as the primary specialist, managed clinical trials from inception to completion, managed eCRF’s on global phase three trials (in Chronic Lymphocytic Leukemia, and Multiple Myeloma) and phase four trials (Multiple Schlerosis), worked with international clinical study sites on protocol compliance, created numerous documents in regard to these clinical trials to comply with GLP regulations.

• Flow Cytometry Specialist

  • Dec 2005 - Dec 2007

  Carlsbad, Ca ·Ran study-specific flow assays as the primary technician. Assisted in the Validation of three functional flow assays and one standard flow assay for an outside company. Setup proper procedures for reagent tracking and assay setup. Streamlined assay procedures for smooth and simple runs.



Group Technology

• Information Technology & Services
• 1 - 100 Employee

• Clinical Research Contractor

  • Sep 2005 - Dec 2005

  Contracted my services in the transfer of clinical laboratory oncology and RA testing, samples, archive, and process to outsourcing labs (CRO’s.) Biogen Idec decided to outsource all in house clinical trials and brought in myself as a contractor to help existing trials reach endpoints and move testing to offsite without data corruption and/or damaging testing quality.



Biogen

• United States
• Biotechnology Research
• 700 & Above Employee

• Research Associate II

  • Sep 2002 - Sep 2005

  La Jolla, CA Headed Sample Management for ELISA and FLOW work groups, worked with multiple Cancer and RA clinical sites and CRA’s for data quality, data storage and reporting, stained and ran Flow Cytometery samples, ran high throughput phase III ELISA samples, FICOLed cells from blood for testing, ran Intracellular cytokine staining, was in charge of freezer install, organization, usage, and validated studies. and kits, helped lab meet FDA/GLP standards, worked with SQL LIMS for sample management… Show more Headed Sample Management for ELISA and FLOW work groups, worked with multiple Cancer and RA clinical sites and CRA’s for data quality, data storage and reporting, stained and ran Flow Cytometery samples, ran high throughput phase III ELISA samples, FICOLed cells from blood for testing, ran Intracellular cytokine staining, was in charge of freezer install, organization, usage, and validated studies. and kits, helped lab meet FDA/GLP standards, worked with SQL LIMS for sample management (logging, tracking, pulling, running), used and maintained Sysmex hemocytometer and FACSCaliburs, worked as second tech for validation on Cellular Bead Assays, wrote SOP’s, and integrated new systems processes into our GLP environment, assisted with any computer or technological problems that any Clinical Immunology employees came across, used sterile technique and good lab practices Show less



Baylogics

• Executive Assistant

  • Jan 2002 - Jun 2002

  San Diego, California