Aerosol Expert for Performance Studies and Regulatory Agency Compliance

Expertise

• Aerosol issues (troubleshooting, clogs, leaks, failures) and aerosol performance studies.
• Quality assurance, control and regulatory with experience in manufacturing OTC drug products.
• Communication and compliance with FDA, EPA, CARB.
• Developing new systems capable of tracking location and status of all components, raw materials, and finished goods while product is in operation.

Experience

Undisclosed Company, Quality Regulatory Manager, 2010 - Present

• Manage and oversee daily routines for the Quality Assurance/Control and Regulatory Departments.
• Responsible for systems related to the manufacture of OTC Products which include:
• Creating and executing process validation protocols and issuing associated summary reports.
• Review and approve OTC batch cards and completed production packets.
• Oversee vendor qualification for active ingredients.
• Maintain National Drug Code (NDC) coding system.
• Review and approve all regulatory documents prior to submission to Customers and/or Regulatory Agencies.
• Oversee the facility's equipment qualification and cleaning and sanitization validation programs.
• Direct communication with customers regarding quality and service complaints, new projects and quality issues.
• Responsible for communication with appropriate regulatory agencies. FDA, EPA, CARB.
• Complaint investigation and resolution as well as research and development and/or production aerosol failures or issues.

Sage Quality Systems, Riverside, CA, Quality Systems Consultant, 2009 - 2010

• Onsite consultant for start-up of a liquid filling site in Culver City.
• Day to day duties:
• Purified water system validation.
• Cleaning and sanitization procedures and validation.
• Created master formula and processing instructions.
• Quality Control Laboratory instrumentation set up and calibration.
• Raw material, bulk and finished product specifications.
• Designed a system for standards and retains maintenance for raws, bulk and finished product.
• Performed internal auditing of production packets and subsequent training based on findings.
• Trained quality personnel.

KIK Custom Products, City of Industry, CA, Technical Director, 2005 - 2008

• Approximate out-put of 85 million pieces a year, roughly 60 - 65 million of which were aerosols and 20 - 25 million liquids.
• Managed daily operations for the Quality Assurance/Control, Specification and Regulatory Departments.
• Direct reports include QA Laboratory Manager, Regulatory Manager, Quality Supervisor and Specifications Manager.
• Oversee the facility's quality and GMP programs to insure compliance with regulatory agencies and customer requirements.
• Direct communication with customers regarding quality and service complaints, new projects and quality issues.
• Ensure daily and on-going compliance with all appropriate regulatory agencies. FDA, EPA, CARB.
• Interface with corporate to assist in setting the strategic direction of quality for KIK.
• Participate with and support customer service and sales in responding to and resolving customer complaints.
• Performs final review and approval of all new product specifications prior to production.
• Implemented a Positive Release System in conjunction with the Implementation of a new operating system capable of tracking location and status of all components, raw materials and finished goods.
• Substantial quality systems improvements were implemented.
• Research and development of aerosol failures or issue, conducted aerosol clogging and leakage studies and investigations.
• Proven dynamics of production line for a typical hair spray can be set up so as to produce almost 100% cloggers.
• Implemented quality systems that resulted in a 77 point improvement in the facilities overall P&G audit rating:
• Validation program.
• Self-improvement program.
• Customer learning / complaint investigation.
• Line clearance and set up.
• Calibration program.

Aerosol Services, City of Industry, CA, 1995 - 2005

Analytical Services and Quality Assurance Laboratory Manager, 1998 - 2005

• Implemented new safety policies which resulted in 50% reduction in plant's OSHA safety rating.
• Improved quality of product and efficiency of production by working closely with managers and employees of other departments.
• Implements GMP's through participation as a member of the GMP committee and employee training.
• Revises current SOP's, writes new SOP's, and continuously monitors the adherence to procedures.
• Troubleshoots, investigates, and determines disposition of problematic batches, raw materials, and finished products.
• Maintains daily laboratory operations of employee scheduling, material ordering, and instrumentation operation.
• Generates specifications for company formulated products and refines customer generated specifications.
• Performs customer complaint investigation and technical reporting.
• Responsible for review and approval of test specifications and formulations for new products.
• Responsible for product and process validation.
• Interviews, hires and trains all new employees.

Chemist, 1995 - 1996

• Performed analytical and quantitative tests on raw materials.
• Responsible for testing and releasing batches for production and finished products for shipping.
• Responsible for correcting problems found in batch samples and finished products.
• Effectively communicated with line employees, compounders, and mechanics to produce a quality finished product as identified by the customer.

Neilsen Research Corporation, Medford, OR, Inorganic Supervisor and Chemist, 1996 - 1998

• Conducted all training of inorganic employees.
• Managed daily responsibilities for laboratory analysts.
• Oversaw state mandated quality assurance and quality control protocol.
• Responsible for revising current standard operating procedures and writing new standard operating procedures for inorganic methods.
• Improved overall quality of data by reducing acceptable error on quality control samples.
• Reduced turnaround time of client samples by maximizing available resources.

Chemist Duties

• Responsible for inorganic lab testing.
• Testing methods included IC, Metals by AA (flame and furnace), UV-VIS Spec, and titrimetric methods.

Honors & Publications

Credentials

• 40 Hours ETP Training
• 5 Day P&G QAKE Training
• 3 Day ASQ Internal Quality Auditor Training

Academic and Professional Affiliations

• Safety Committee, Aerosol Services
• Good Manufacturing Committee, Aerosol Services

Education

• B.S. Chemistry, California State Polytechnic University, Pomona, CA