Quality Control Specialist

• Apr 2021 - Present

Quality Technician

• Jun 2019 - Apr 2021

Responsible for sampling, disposition, and analytical testing programs for current batches, sample retains, and stability. Responsible for sampling, disposition, and analytical testing programs for current batches, sample retains, and stability.

QC LIMS System Analyst

• 2005 - 2019

• Created and maintained analyses, calibration intervals, alert limits, product specifications and stability protocols in LabWare LIMS, supporting over 130 product families.• Authored and implemented cross-functional Standard Operating Procedures (SOPs), decreasing redundancies and paper processes while improving site compliance. • Planned and coordinated system effective dates and Compendia updates, working closely with Document Management, Quality Assurance, and Regulatory Affairs.• Provided LabWare LIMS training and customer support for over 60 QC employees.

Quality Control Team Leader

• 2003 - 2005

• Managed a team of 6 chemists, delivering accurate quick turnaround results to the manufacturing team. • Implemented High Performance Work Cells across two shifts to achieve continuous high throughput supporting a high demand, fast paced production schedule. • Provided supervision, training, and data review for all testing including Blend Uniformity, Packaging Components, Bottles, Closures, Capsules, and Colors.

Quality Control Chemist

• 1997 - 2003

• Tested, reviewed, and released Active Pharmaceutical Ingredient (API) and Excipient batches following USP and internal methodology. • Participated in Continuous Improvement, Lean, 5S, and Work Cell projects including implementation of analysis templates to replace lab notebooks. These improvements reduced testing cycle time by 50%. • Chaired Safety Team, and provided support for the Hazardous Waste Team. Adhered to current Health, Safety, and Environmental (HS&E) Procedures and Department of Transportation labeling of waste streams.

QC Organic Prep Analyst/Team Leader

• 1994 - 1997

• Assigned work responsibilities and managed a team of 5 analysts. • Tested and released environmental samples following Contract Protocol. Testing included BNA, PCB, Pesticide, and Herbicide extractions on aqueous and soil samples. • Developed a visual work management system to better manage incoming samples, backlog, and due dates. These improvements led to increased internal customer satisfaction, and reduced prep lab cycle time by 25%.

QC Organic Prep Lab Technician/Analyst

• 1990 - 1994

• Assisted with sample preparation, balance calibrations, and sample chain of custody.• Stocked and ordered laboratory supplies using Just in Time and Kanban principles.• Washed and rinsed glassware.• Disposed of solvent/acid waste, provided employee training on safety requirements and use of personal protective equipment (PPE).