Director Microbiology Plant Sanitation

Company Name:
Human Capital Resource LLC
The Director of Microbiology and plant Hygiene is 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 our products are produced and delivered under the best quality processing conditions.
Job Description:
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
Education: Masters/Bachelors Degree in Microbiology or a Life Science with Chemistry background. Masters or PHD preferred.
Five (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.

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