Aerosol Expert for Performance Studies and Regulatory Agency Compliance

Technical Consultant #1809


  • 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.


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


  • 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


  • B.S. Chemistry, California State Polytechnic University, Pomona, CA
Save Resume #1809
to Contact Form?

You must first click "Yes" to save this resume

Submit Request

You have no Saved Resumes

Add resumes within our various Ares of Expertise by clicking "Add Resume(s)" below.

Add Resume(s)