cGMP Manager at Kodak in Rochester, NY 1766_1498337
cGMP Manager
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  Closed for new applications

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Rochester / NY
Employment type
Job description

Job Description:

Kodak is Hiring!

We are looking for a cGMP Manager to join our Advanced Materials and Chemicals division in Rochester, NY.

In this role, you will develop and implement a cGMP compliant quality system, and manage the Quality Assurance Organization in support of the commercialization and manufacture of chemicals used within the pharmaceutical marketplace.

The ideal candidate will have cGMP management skills and a deep knowledge of Quality Assurance.  The manager will lead the Quality Assurance group and implement quality systems for Kodak's chemical manufacturing division, ensuring that pharmaceutical  related products are manufactured within cGMP guidelines.

Key Responsibilities to include:
  • Create and maintain a Quality Assurance program that is designed specifically in support of the manufacture of APIs
  • Oversee the conversion of a portion of Kodak's Fine Chemicals multipurpose batch plant to cGMP compliance
  • Review legacy quality system and upgrade to meet cGMP standards
  • Develop and maintain SOPs required for obtaining cGMP certification
  • Manage the Quality Assurance organization

Required Skills/Experience:
  • Experience operating within a cGMP Environment
  • Experience in Quality Assurance Management
  • Ability to identify investments necessary to meet business objectives
  • Ability to manage and meet project timelines
  • Thorough understanding of FDA regulations pertaining to CMOs
  • Experience implementing cGMP within an organization that is ISO certified
  • Highly effective at building and driving collaborations across organizational boundaries
  • Experience in preparation of FDA audits
  • Bachelor’s Degree in related field +10 years' experience supporting a cGMP environment, OR an Advanced Degree (M.S. or above) in a related field +5 years' experience supporting a cGMP environment

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About Kodak
Kodak is a technology company focused on imaging. We provide - directly and through partnerships with other innovative companies - hardware, software, consumables and services to customers in graphic arts, commercial print, publishing, packaging, electronic displays, entertainment and commercial films, and consumer products markets.

cGMP Manager

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