Oversees the operation of the pharmaceutical microbiology laboratory. Provides Microbiology support for internal products and for client products. Manages the company's environmental monitoring program, microbiology method development, method validations, laboratory equipment validations and compendial testing. Determines root causes and Corrective Actions-Preventive Actions (CAPAs). Trains personnel on pharmaceutical microbiology. Responsible for all QC Microbiology Trend Analyses, Risk Analyses, Standard Operating Procedures, Protocols, Training Modules, Development Plans and other technical documents.

As an Associate of PPG, Laura provided Microbiology support. This contamination control and QC Microbiology expert, functioned as investigator for pharmaceutical manufacturing operations, medical devices, environmental monitoring and microbiology testing including OOS, alert and action level events. Determined root causes. Recommended and negotiated CAPAs. Conducted audits. Created Training, Stability and Auditing Programs. Wrote Standard Operating Procedures, Protocols, Training Modules, Development Plans and other technical documents.

Functioned as Microbiology Manager. Scheduled, prioritized and tracked samples, testing, reports, investigations, CAPAs and complaints. Managed up to 41 employees. Executed equipment IQ, OQ and PQs. Created and executed QC microbiology method validations. Trained production personnel in aseptic techniques and cleanroom behavior. Designed and documented Corporate and Site Specific Training Programs. Collaborated with diverse teams to meet all goals. Conducted GMP audits and investigations. Created SOPs, protocols, training plans and other documents. Reviewed and approved documentation.

Managed method qualifications, in-process testing, release testing and stability studies in support of clinical trials. Responsible for project staffing. Oversaw daily activities and prioritized team’s work. Prepared/revised stability and method qualification protocols. Sourced and selected testing laboratories and manufacturing facilities. Coordinated stability studies. Collaborated with engineers to design new cleanrooms. Reviewed electronic batch records. Coordinated sample retention, storage of products, management of documentation and distribution of clinical supplies to human study sites. Assisted in quality investigations. Collaborated in CAPA for specific products. Recommended process improvements. Managed complaint investigation initiations and resolution of Out of Specification (OOS) results with vendors. Reviewed Certificate of Analyses (COA) for raw materials and finished products.

Reviewed and approved vaccine manufacturing equipment IQ and OQ protocols pre and post execution in support of a new manufacturing building. Reviewed and approved deviations, calibrations and work orders (maintenance records). Experienced with drawings, Functional Requirement Specifications (FRS), commissioning, equipment validation and Process Controlled System (PCS) validation (Delta V). Work at Wyeth Vaccines was through Kelly Scientific.

Consulted in QC and QA. Created corporate training seminars. Presented technical training programs to over 500 scientists per year. Trained personnel on equipment validation, change control, compliance, investigations and effective corrective actions. Conducted GMP audits of pharmaceutical laboratories. Directed and provided customer service. Scheduled, prioritized and tracked client projects. Supervised 6 direct reports. Created a Pharmaceutical Quality Control training manual.

Taught an introductory course in microbiology to respiratory care technicians. Course was offered once per year.

Advised pharmaceutical companies on regulatory requirements, and testing requirements for marketed products, research samples and clinical trial materials. Represented company in over 95 client audits per year. Supervised 2 direct reports. Authored a microbiology training manual. Specialized in detailed technical training of USP methodologies. Created protocols for a wide variety of method validations, method transfers and method development. Prioritized and tracked all laboratory testing and report generation. Reviewed all laboratory reports to ensure client expectations were met. Interacted with over 120 pharmaceutical companies per year serving each one as consultant on regulations affecting microbiology testing for small and large molecules. Provided and assisted customer service. Trained laboratory personnel in autoclave validation. Collaborated in creation of validation protocols. Audited laboratory for GMP compliance. Wrote and/or revised Standard Operating Procedures (SOPs). Guided creation of Test Methods. Discussed and facilitated method transfers.

Conducted manufacturing and laboratory investigations; recommended and implemented CAPAs. Reviewed stability studies, batch records and complaint investigations. Issued Certificate of Analyses (COA) and released finished products. Trained personnel (including sales force) and audited documentation. Prioritized and tracked Spore Production team's work. Designed and conducted research. Presented and implemented cost savings ideas for Laboratory Supplies reducing costs by 25%. Supervised 1 direct report and 3 indirect reports (all supervision responsibilities except evaluations). Quality Microbiologist Performed QC product testing. Reviewed and approved batches for release to market. Conducted failure investigations for OOS results. Responsible for implementing CAPAs in Spore Production. Conducted a complete overhaul of the cleanrooms and was responsible for their management after implementing significant CAPAs. Authored and revised all Standard Operating Procedures for Spore Production. Increased spore stocks from a 2 week supply to a 1 year supply. Participated in FDA audits.