Quality Assurance Executive
Significant experience leading QA/QC for companies in pharmaceutical, nutraceutical, and cosmetics manufacturing.Ensure FDA, ISO and cGMP regulatory compliance. Provide leadership to motivate staff for continuous improvement to increase quality awareness, productivity, and profitability. Excellent problem solving, management, communications, and customer service skills. Master of Business Administration, Graziadio School of Business and Management, PepperdineUniversity.
STRENGTHS & SKILLS
Strategic Planning & Analysis … Project Management … Systems Implementation … Multi-site Operations
Supply Chain Management … Budget Management … Continuous Improvement
Microsoft Office … QAD Mfg Pro Enterprise Resource Planning Systems …Mass200 Accounting Systems
Compliance & Risk
·Developed quality system that ensured product compliance and reduced risk of FDA regulatory action.
·Successfully registeredapproximately 100 products internationally to meet all regulatory compliance requirements.
·Established detailed company wide operating procedure and training program which lead to consistent business processes and reduced returned merchandise shipments by 20%.
·Created Engineering Change Order process to track all product revisions; this increase accuracy of BOM system and ensured correct product was manufactured.
Cost Reductions & Savings
·Developed internal regulatory expertise andreduced annual international regulatory outside consulting cost by $35K per year.
·Realized an annual savings of $90K per year through improved efficiencies and increased operation capabilities.
TeamBuilding & Training
·Instituted mentoring program for new employees that increased efficiency of employee training and employee work production.
·Developed management program that provided training and education course work to prospective managers; this lead to the promotion of more successful first time managers.
Irwin Naturals, Inc.August 2008 to Present
Privately owned mid-sized manufacturer of dietary supplements and nutritional products.
Director of Technical Operations
Responsible for managing the quality, regulatory, research and development, and consumer affairs departments as well as creating and implementing corporate compliance program that ensures company is cGMP compliant; reporting to Chief Financial Officer.
Challenge:Tasked with developing a rugged quality system with the expectation of making the Company compliant with newly instituted dietary supplement Good Manufacturing Practices regulations.
Action: Created and developed quality and regulatory departments to handle key quality responsibilities. Instituted detailed processes to direct creation and maintenance of formula specifications. Created stability program that substantiated the expiration date on all products.
Results: The Company is now compliant with current dietary supplement regulations; company successfully passed first quality audit by an independent quality and regulatory organization.
Thibiant International, Inc.January 2005 to August 2008
Privately own mid-sized contract manufacturer of cosmetics and personal care products.
Director of Quality Assurance
Report to the Vice President of Quality and Regulatory Affairs responsible for managing the chemistry and microbiology laboratories in testing and release of raw materials, bulk product, and finished goods in accordance with internal procedures and government regulation.
Challenge: Tasked with increasing the efficiency of laboratory and developing process validation program.
Action: Reorganized Stability and Analytical departments and instituted efficient daily operating procedures. Established cross training program for key department personnel to expand flexibility of department. Developed and managed a process validation program to substantiate consistent manufacturing process.
Results: Increased efficiency and flexibility of the department by 25%. Through cross training program, a cost savings of $30K per year was realized through staff reductions. A prospective validation program documented the consistent manufacturing processes for the manufacture of OTC products.
Herbalife International, IncNovember, 2000 to January, 2005
Manufacture and distribute nutritional supplements and wellness products globally.
Quality Assurance Senior Laboratory Manager January, 2003 to January, 2005
Quality Assurance Laboratory ManagerNovember, 2000 to December, 2002
Responsible for the implementation of corporate quality systems as well as troubleshoot and resolve quality issues with contract manufactures; reported to the Corporate Vice President of Quality.
Challenge: Tasked with challenge of expanding the testing capabilities of the laboratory and establishment of product specifications.
Action: Hired experienced senior level analytical personnel to develop vitamin test methods. Purchased new analytical test equipment that was used to expand testing capabilities of the laboratory. Instituted analytical and evaluation training which included sensory training.
Results:Successfully increased the testing capability of lab by 500%. The purchase and use of new analytical equipment resulted in $80K annual reduction in outside test cost. Data generated from expanded testing used to establish important product specifications and establish product shelf life claims.
Early Career History: BioScreen Testing Service, Chemistry Supervisor 1996–2000 and Senior Analytical Chemist June–1996; Bachem, Incorporated, Quality Control Chemist, 1987–1992, RanchoLosAmigosHospitalToxicologyTechnicianCounty of Los Angeles, 1986–1987.