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Director of Microbiology and Sanitation

The Company

A leading supplier of products for the Home Care and Personal Care markets in the US and Overseas.

Position Overview

The Director of Microbiology and Sanitation's primary responsibility is to ensure that all microbiological and sanitation requirements under cGMP as well as by local, state and federal guidelines are met and that products are produced and delivered under the best quality processing conditions.

Responsibilities

  • Develop & Review Microbiological and Sanitation procedures and testing capabilities.
  • Continually  strive to improve the quality of work through existing and new technologies.
  • Ensure sample turnaround time goals are met or exceeded.  This includes, but is not limited to, sample preparation for sample analysis, data review and reduction, and providing  data interpretations and opinion.
  • Oversee daily lab operations including: employee  leadership, process control, continuous quality improvement, and innovation through information technology.
  • Ensure regulatory procedures pertaining to sample testing are followed correctly.
  • Responsible for the supervision,  organization, and coordination of all technical activities of personnel within the principles  of sound scientific endeavors  and the professional development of subordinate employees.
  • Manage the technical conduct, quality control, and related record keeping of all microbiological and sanitation evaluations  performed.
  • Represent  the laboratory in technical meetings.
  • Understand and follow each Quality System document  relevant to employment  responsibilities, e.g., methods, SOPs, etc.
  • Ensure Calibrations  are maintained and in compliance for the Lab.
  • Propose changes to documents  and approve documents  when required
  • Handle outsourcing and management of clinical lab studies
  • Review and approve Stability protocols  and studies
  • Audit and Manage contract laboratories
  • Create Certificates  of Analysis
  • Participate in Design Control of new formulations  and packaging
  • Participate in R&D Magic Wand Innovation meetings
  • Manage  Temperature & Humidity monitoring  of all production, laboratory, and warehouse areas

Requirements

  • Education: Masters/Bachelors Degree in Microbiology or a Life Science with Chemistry background. Masters or PHD preferred.
  • Experience:
    • Eight (8) years experience in the pharmaceutical or cosmetic industry.
    • Five (5) years experience in a managerial position.
  • Experience in environmental monitoring, water monitoring, Microbial limits validation, Preservative testing, Celsis, Alternative Rapid microbial detection and FDA 21 CFR 210- 211, ISO, FDA, GMP, EPA, and/or USP specifications.
  • Aseptic technique
  • Experience in Cleaning, Sanitization, and Hygiene procedures and design.
  • Knowledge of Microbiological methods and theory and ability to incorporate them into daily
    tasks and problem solving.
  • Ability to demonstrate skill in performing work accurately and precisely and to be able to
    follow test methodology.
  • Knowledge of FDA 21CFR211, 21CFR820, ISO and related guidance documents
  • Computer Skills - Microsoft Excel, Word, Power Point, and Adobe Acrobat.