Performing onsite and remote audits for Microbiology and Sterilization compliance to ISO 13485, ISO 9001, Medical Device Directive (MDD) and Medical Device Regulation (MDR) for the medical device industry. Contributing as a technical resource to members of the BSI team.

Lead team of 50+ Microbiologist testing pharmaceutical, medical device, and API products in all aspects of microbiological testing. Eliminated a 12 week backlog in the Sterility group and reduced turnover from >40% to less than 10% in the first eight month after joining SGS. Spearheaded a variety of process improvement initiatives, promoted harmonization, and focused on continuous development of the team. Routinely supported Business Development with client contact to increase revenue. Broke records for revenue. Finished first year ahead of budget.

Provided onsite support for remediation of microbiology laboratory in sterile API facility in India. Prepare and lead global training and harmonization initiatives. Onsite audit preparation and support for FDA and BSI inspections, as well as lead onsite audits for contract laboratories. Contributing member to the Aseptic Production Community of Practice concerned with sterilization, environmental monitoring, and production support.

Subject Matter Expert in Microbiology providing technical knowledge, audit support, and gap remediation. Responsible to coordinate and support validation activities at manufacturing sites worldwide and assess risk to product in the field as a result of specification changes. Lead investigations and participate on teams authoring responses to 483 Observations affecting multiple sites, as well as backroom support during FDA inspections. Supporting sterilization validation activities for steam, EtO, e-beam and gamma sterilization.Ensure compliance to USP and ISO standards. Perform gap remediation on sterility and bacterial endotoxin test method validations.

Subject Matter Expert leading the Quality System integration for Laboratory Controls following the acquisition of Hospira by ICU Medical. I support design verification activities from a sterilization and bacterial endotoxin perspective, which has lead to significant savings in terms of testing and greater compliance with ISO standards and FDA guidelines. Support BSI and FDA audits onsite at both Lake Forest and at manufacturing sites. I also perform onsite vendor audits and troubleshoot vendor issues relating to Environmental Monitoring, cleanroom qualification, and nonviable particulate testing. 13485 Lead Auditor Certified.

Subject Matter Expert in areas relating to Environmental Monitoring, aseptic technique, and microbiological testing. Authored procedures to ensure compliance with USP <71> requirements for sterility testing as well as ISO 14644 requirements for Environmental Monitoring. Identified gaps and paths forward for remediation.

Wrote and lead environmental monitoring investigations and deviations. Represented the Microbiology group in cross functional team meetings. Developed training programs, with an emphasis on increasing communication across departments. Routinely gowned and performed environmental monitoring in ISO 5 environments. Responsible for a team of three degreed microbiologists, and worked to increase opportunities for their career development. Authored, performed, and trained operators to support smoke visualization studies to validate RABs system in cleanrooms.

Part time negotiation of real estate transactions. Exceeded national averages for transactions and earnings in 2009. Property Management of over $1.1 million in residential rental properties.

Stay at home caretaker for my two children while looking for permanent employment in the pharmaceutical/biotech fields. Sold firewood on Craigslist for extra income. A wonderful experience, wouldn't trade it for anything.

Performed batch record review and releaseAssisted with internal and external auditsProficient with Oracle data management system

Provided microbiological support as well as analytical method review of HPLC data. Ensured harmonization between relating to Microbial Limits and Chromagenic Endotoxin methods. Revised and authored GMP methods adopted from sister location in Breso, Italy.

Performed analytical tests on in-process and final product samples: FACS flow cytometry, ELISA, chromagenic LAL, CBC counts.Provided microbiological support by reading CFR sterility bottles, EM plates, and Gram stains. Reviewed in-process and final product documentation.

Lead a team of up to 4 associates through shutdown of the facility.Responsible for review of all environmental monitoring and water testing paperwork.Created and routed company-wide reports for EM and water testing.Lead all microbiological-related investigations.Ensured compliance with federal regulations.Implemented new technologies.Championed cross-training of direct reports.

Lead the revision of all environmental monitoring documentation.Trained all QC and manufacturing staff in aseptic technique and clean room gowning.Implemented new technologies.

Primarily responsible for sterility testing and environmental monitoring.Validated novel technology to reduce product release time from 14 to 7 days by replacing the USP sterility test.Lead all microbiological investigations.Wrote protocols submitted to, and approved by, the FDA.

Responsible for training employees on D-value determination, biological indicator preparation, and container integrity testing. Prepared sections in submissions to the FDA. Performed validation studies in manufacturing sites in Puerto Rico as well as the United States.Represented Sterility Assurance in cross-disciple product development teams.Responsible for performing and scheduling of microbial ingress testing.