Experience

Diasorin - Molecular

• United States
• Biotechnology
• 200 - 300 Employee

• Production Supervisor

  • Nov 2018 - Present



NAMSA

• Sterility Assurance Supervisor

  • Feb 2015 - Nov 2018

  Directly responsible for overseeing of Sterility testing of BIs, SCBIs, product testing, HCTP, pharma samples by means of Direct transfer, Membrane Filtration, In-situ and ensure dynamic schedule are met and in compliance with SOPs, cGMPs, QSR, GTP, ISO standards and company procedures. Manages In-house media preparation, weekly schedule, sustaining in-house media inventory for Sterility Assurance department. Conducts nonconformance investigation (Trackwise), Planned Deviation, Risk Assessment, CAPA and Effectiveness Check. Report reviewer and approver. •Established min-max for in-house inventory resulting in timely delivery of client’s test results •Client communication- including responding to client’s prelims results, culture check, testing due updates •Selects, develops and evaluates personnel to ensure functional objectives are met and ensured all team members have the appropriate skills and training necessary to successfully perform their tasks •Collaborates with Medical Research Managers/Client Care for scheduling of client’s sterilization validation projects (fractional, half cycle and full cycles) resulting in client’s meeting their project’s deadline. •Optimized numerous Logs and SOP’s to increase efficiency and to be in compliant. Show less



Intechrity, Inc.

• Production Supervisor

  • Apr 2012 - Sep 2013

  April 2012 – September 2013 INTECHRITY Inc., Irvine, CA Responsible for supervising and guiding the activities of manufacturing personnel to ensure production schedule, substantial inventory and timely delivery of finished products are met while adhering to established procedures. • Mentored diverse group of direct reports on cGMPs, GDP and Safety, resulting in a highly efficient production performing team • Implemented corrective and preventive actions on mislabeling and miscounts thus reducing the NCRs • Resolved inventory issues by organizing raw materials and synchronizing quantity on hand, ensuring accuracy in logs and in the WASP system • Spearheaded various projects such as the Gowning cost reduction program which also maximized process efficiencies Show less



Integra Orthobiologics

• Orange County, California Area

• Senior Manufacturing Manager

  • Oct 2008 - Dec 2011

  Directly responsible for effectively managing production of assigned products to ensure daily priorities, project deadlines and dynamic schedules are met in compliance with SOPs, cGMPs, QSR, GTP, ISO standards and company procedures. • •Consistently monitored weekly scheduling of product shipment to E-Beam and Gamma sterilization facilities resulting in process efficiency and substantial reduction of back-order and cost savings of ~$6k/month or more • Developed and streamlined production work standards to meet quality and regulatory requirements • Actively contributed in Internal/External Audit, CAPA /NCR closure and Lean manufacturing initiatives Initiated and implemented the optimization and consolidation of complex Manufacturing Work Instructions/QA documents from “start to finish”. The successful project resolved and prevented numerous issues such as: 1) Closing of ~ forty one (41) corporate audit findings 2) Elimination of redundant documentation entries 3) Substantial increased productivity on the manufacturing floor by 30% 4) Simplified QA's final review and compilation of the Lot History/Batch Record prior to product release and greatly increased efficiency by 50% 5) User-friendly and prevented operator’s documentation errors • Actively provided R&D support, participated in design control, FMEA and risk management activities • Collaborated with other functional areas to ensure accomplishment of overall plant objectives: Engineering/QA support on Validation projects such as optimization of steam disinfection process/E-beam/Gamma sterilization processes, in-vitro testing, packaging integrity, new equipment/new components • Provided direction to Facilities and EHS Departments, implemented CAPA activities and maintained facility beautification projects • Managed the critical Labeling operation of the Packaging Department and staging of components to ensure timely completion of build plan and special projects Show less



Isotis OrthoBiologics

• Orange County, California Area

• Manufacturing Manager

  • Nov 2004 - Oct 2008

  Responsible for managing the company's manufacturing operation to ensure daily priorities, project deadlines and dynamic schedules are met in compliance with SOPs, cGMPs, QSR,GTP ISO standards and AATB compliance requirements as well as company procedures. Scheduled packaging activities and anticipated timelines and delivery dates as well as tracking and updates of all activities. • Managed labeling, staging preparation and steam disinfection (Autoclave ) processes • Responsible for timely investigation and closure of assigned NCRs and CAPAs • Managed department processes and associated documents (SOPs, WIs, specs, labeling artwork and forms) to meet compliance requirements • Review and revision of procedures, specifications and forms and updates applicable logs/ databases • Represented manufacturing department in internal, corporate, 3rd party audits and regulatory audits (FDA, AATB) cross functional teams and projects • Closely worked with R&D and process engineering to support development of new products • Developed production work standards meeting quality and regulatory requirements and conducts training of department processes • Collaborated with Inventory/Purchasing/Planning and QA/QC Department and anticipated the completion and released of weekly build plans ahead of schedule • Provided guidance, directions and training to direct reports (Supervisors and staff) to become a highly efficient production performing team. Show less



GenSci OrthoBiologics

• Orange County, California Area

• Production Supervisor

  • Jul 1998 - Nov 2004

  Responsible for supervising various manufacturing processes which include product formulation in clean room environment, labeling and final packaging operations, steam disinfection process, scheduling of Gamma/E-Beam sterilization activities, freeze drying operations and review of batch records/shop orders. • Optimized receiving and shipping of product to and from sterilization facilities resulting in increased efficiency in the receiving process • Selects, develops and evaluates personnel to ensure functional objectives are met and ensured all team members have the appropriate skills and training necessary to successfully perform their tasks • Coordinated with other departments (Materials/QA/QC) and anticipated timely completion and release of product to Finished Goods Area • Coordinated scheduling of lyophilizer (freeze-dryer) operation and steam disinfection (autoclave) activities to maximize equipment efficiency and prevented zero downtime • Conducted time studies and anticipated output and equipment efficiency • Trouble shoot associated equipments thus preventing delays in the manufacturing floor Show less