Assure all company SOP and external regulation compliance requirements are met through observation and documentation review and approval. Perform trending, routine monitoring, and auditing of pharmaceutical manufacturing from procurement through manufacture and analysis identifying deviations, deficiencies, and continuous improvement needs and implementing appropriate CAPA. Leading cross functional teams, develop, implement, and enforce compliance strategies to reduce or eliminate compliance gaps. Approve global validation and qualification documents, local control specifications, Test Methods, SOPs, Work instructions, Validations, Qualifications, Change Controls, and Risk Assessments.● Managed a laboratory renovation project leading a cross functional team to increase testing efficiency. ● Reduced investigations by 41% by implementing the correct CAPAs by mentoring and coaching personnel in investigation writing, root cause analysis, and identification of CAPAs.● QA CMO Contact for customer QA representatives to identify and resolve issues.● In a Data integrity Project, evaluated manufacturing equipment for adherence to data integrity guidelines and put in place remediation plans where necessary. ● Lead up to 12 internal audits of different departments to assure compliance with FDA regulations and SOPs, improving the quality systems, averaging no critical and less than 1 major observation per audit.● Hosted and supported customer audits and FDA inspections which included 2 successful PAI audits.● Managed a team where 100% of outstanding archival was completed from gap analysis, gap remediation, documentation and finally archival.

Lead Polysaccharide and Drug Product manufacturing investigations from initial deviation through final closure, including personnel interviews, root cause analysis, batch impact, and corrective and preventative actions. Assigned commitments as needed to improve or correct the system. Lead meetings to brainstorm and work around any potential obstacles with investigations.•Aseptic process and potential contamination certified. •Participate in housekeeping audits

Led laboratory investigations from initial deviation through final closure. Ran stability samples as well as troubleshot GC and HPLC. Audited and reviewed notebooks and data for adherence to internal procedures as well as cGMPs in routine stability testing and method transfer testing•Hand picked to participate in a cross training developmental assignment to bring best practices to two sites.•Lead the 5S initiative to streamline and better organize the lab.•Contributing author to the department wide newsletter.•Performed glassware washer validation to increase glassware availability for testing.•Authored and reviewed methods, protocols, validations, SOPs and reports.•Assumed all supervising responsibility for a group of 6 when the supervisor was away.

Recruited and selected to perform routine testing, calibrations, method validations and method transfers. Led investigations, deviations and CAPAs on an as needed basis. Audited and reviewed notebooks, and reports for adherence to internal procedures and cGMPs.•Developed and led a FDA Readiness Program for inspections.•Authored and reviewed numerous methods, protocols, validations, SOPs and reports.

Audited quality control and research and development data. Author and reviewer of protocols for IQ, OQ, PQ, Method Validations, reports, as well as several SOP’s and forms in the Quality Systems International (QSI) documentation system. Performed day-to-day analysis, and validation on LidoSite Iontophoretic Patches.•Performed method transfers.•Conduct Out of Specification, Out of Calibration, and unknown peak investigations.•Implemented a template and logbook system to conform to cGMPs and assure consistency throughout the Quality Control lab.•Trained new lab personnel on HPLC’s and the Empower data acquisition system.•Developed a technique to test an oxygen sensitive drug in an inert environment.

Performed release, stability, and database generation for multiple products including inhalation methods. Calibrated laboratory instrumentation. •Researched, evaluated, purchased, and authored Instrument Operating Procedure for new Atomic Absorption instrumentation.•Collaborated with other members of the Computerized Electronic Training System team to validate the database as a response to an audit observation. Maintained an accurate and current training employee training database.•Recording Secretary for the laboratory GMP committee.