Performs defined quality control microbiological procedures. Tests and evaluates raw materials, bulk, package components, finished goods, and special samples as required. Compile, analyze and report on quality performance data in order to direct and prioritize quality improvement efforts for areas of production. Practice and enforce good laboratory practices in the GMP laboratories.
- Ensures compliance with current procedures, specifications and methods.
- Maintains accurate records of test results and issues reports as required.
- Performs and/or manages air, water, and environmental sampling.
- Performs and/or manages microorganism identification on environmental, water and product isolates. Maintain accurate records on all isolates.
- Performs and/or manages preservative efficacy testing with outside laboratory as appropriate and recording of results.
- Responsible for alerting senior member of management of potential problems in the areas of quality control.
- Manage training and development of personnel assigned, continually encouraging 100% employee engagement (if applicable).
- Analyze and report on bulk, raw material, and finished goods.
- Analyze and report status on quality incidents, raw material, bulk, and finished good non-conformances. Conducts OOS investigations.
- Develop quality trends based on analysis of waivers and non-conformances. Identifies plan for improvements.
- Develop training and train laboratory personnel on the use of new test methods and equipment.
- Involvement and follow up on the corrective action process.
- Purchase and implement new test equipment for the Industrial Quality Laboratories.
- Manage and enforce the compliance to ISO, GMPs, FDA, DGO regulations.
- Leads a team of professionals and technicians, continually encouraging 100% employee engagement.
- Carry out all duties in accordance with Good Laboratory Practices.
Educational or Certification Requirements:
- Bachelor’s degree in Microbiology or other related science.
- Quality & Hygiene Regulations – FDA, HACCP, or relevant.
- 5+ years’ experience in a related industry, cosmetic experiencepreferred. Must have experience in dealings with FDA and/or Equivalent audits.
- Must demonstrate excellent people management skills including the ability to develop a team of individuals capable of producing extraordinary results.
- Personal computer skills, to include experience with spreadsheets, presentations, and database management.
- Good level of understanding of Quality & Hygiene Regulations – FDA, HACCP, or relevant
- Experience with SAP a plus.
- Experience with lean laboratory a plus.