Kelly Scientific Resources is working with a Medical Device manufacturing firm in Morrisville, NC seeking a validation associate to write, revise, review and approve EO validation protocol. This is a 3-5 month project on the day shift.
- Prepare and execute sterilization validations and test protocols/reports for all internal and external sterilization facilities.
- Provide support when evaluating the impact/efficacy of existing sterilization methods on new products or new product designs
- Evaluate the impact of new or modified manufacturing related changes on existing sterilization methods.
- Maintain and execute a sterilization and biocompatibility program/policy to ensure all products and processes comply with the regulatory standards.
- Provide input to creating strategies to assure compliance to regulatory standards regarding sterilization
- Provide support for company-wide, consistent and compliant methods for the following: EO Residuals, bioburden monitoring, environmental monitoring, cleanroom practices, and bacterial endotoxin testing.
- Train appropriate company personnel on sterilization and microbiological methods and processes as needed.
- Ensure company documentation related to sterilization and microbiological controls are maintained and updated with most current regulations, standards, and industry practices.
- B.S. degree in Biology, Chemistry, Microbiology, Engineering or related scientific discipline
- 3+ years of experience in EO sterilization of medical devices.
- Strong communication skills (written and verbal)
- Prior experience writing and reviewing validation protocol in a GMP setting
Perks of working for Kelly?
As a Kelly Services employee, you will have access to numerous perks, including:
- Exposure to a variety of career opportunities as a result of our expansive network of client companies
- Career guides, information and tools to help you successfully position yourself throughout every stage of your career
- Access to more than 3,000 online training courses through our Kelly Learning Center
- Weekly pay and service bonus plans
- Group- rate insurance options available immediately upon hire*
NOTE: Please submit resume in MS WORD format
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