The gtech microbiology lead is responsible for ensuring that all new products in development meet the requirements of qs 023 – microbiological control and qmic 0037 (microbiological approval on new and modified formulas) and qmic 0085 (microbiological approval for new product formats) and continuous improvement of the global microbiology multi-faceted technical program.
core responsibilities:
* interfaces with global & divisional quality/microbiology teams to provide input on programs, procedures and methods.
* obtains approval for exemptions to the micro approval process (map).
* supports the implementation of global programs on a divisional basis e.g., celsis, training programs and tools.
* presents divisional/regional challenges to global microbiology and other gtechs. In partnership with global microbiology, other gtechs and individuals, lead efforts to find solutions to regional challenges.
* participates in internal audits (including microbiology laboratory) and external audits (external manufacturers & labs, suppliers, etc.).
* functions as part of the divisional quality team.
* supports the product development process.
* partners with product development groups to improve formula robustness.
* provides guidance on raw material micro susceptibility and required information on methods and specifications. Leads the development and continuous improvement of the map according to category (and any regulatory) requirements and limitations.
* supports the technology transfer process including appropriate microbiology training.
* reviews and approves protocols and test methods developed to support claims for regional products. Working with local cp regulatory, ensures that they will satisfy local regulatory requirements.
* reviews and approves protocols, spis (sops), reports, (deviations and exemption where applicable) to thoroughly document all activities.
* develops and implements rapid micro methods program including celsis, charm, etc.
education & qualifications:
* bachelor’s degree in microbiology or related major. Master’s degree or ph.d. preferred. Must include significant coursework in microbiology (four courses).
* at least ten years of industrial experience (personal care, pharmaceutical, food, environmental). This experience should include working in both laboratory and plant environments with exposure to micro control programs.
* functional knowledge of standard qa testing (contamination checks, preservative effectiveness, identification systems) is a definite plus.
* engages site, division and manufacturing and technology management as necessary to provide appropriate leadership and resources to ensure full conformance to the quality and micro control standards.
seniority level
mid-senior level
employment type
full-time
job function
manufacturing and research
industries
consumer services and manufacturing
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