Associate Scientist, Sterility Assurance

Position Summary

Support sterilization/microbiological methods and process controls related to purchased products designed by Teleflex Medical and manufactured by contractors, products designed and manufactured by Teleflex Medical and/or purchased products labeled and sold by Teleflex Medical.  Review and approve sterilization cycle development, process validations, equivalency reviews, alternate sterilization methods, facility environmental controls and product microbiological controls (as needed). 

Principal Responsibilities

•    Collaborate with Global Procurement and the site/business unit quality team(s) to provide the appropriate sterility assurance support for purchased finished good (PFG’s) and sterilization suppliers.
•    Serve as a sterilization subject matter expert in Purchasing & Supplier Controls
•    Prepare and execute sterilization validations and test protocols/reports for all internal and external Teleflex Medical sterilization facilities (as needed).
•    Evaluate impact/efficacy of existing sterilization methods on new products or new product designs. Act as sterilization expert for teams bringing new products to market.
•    Evaluate the impact of new or modified manufacturing related changes on existing sterilization methods.
•    Provide support for sterilization practices to ensure all products and processes comply with the regulatory standards.
•    Provide input to creating strategies to assure compliance to regulatory standards regarding sterilization for Teleflex Medical products.
•    Provide sterilization expertise during internal and external audits. 
•    Provide support to ensure contract manufacturers use consistent and compliant methods for the following:  EO Residuals, dose audits, dose setting, dose mappings, dose augmentations, bioburden monitoring, environmental monitoring, cleanroom practices, and bacterial endotoxin testing. 
•    Provide sterilization, microbiological and environmental control expertise during supplier quality audits of critical suppliers/vendors (as needed).
•    Provide expertise in support of process deviations.
•    Support developing, implementing, and executing proactive supplier risk profiling to identify and eliminate potential supplier risks.
•    Support sterilization supplier facility compliance audits to ensure sterilization and microbiological controls are maintained and updated with most current regulations, standards, and industry practices.
•    Support developing and implementing management reporting tools for in-crisis suppliers and proactive risk monitoring. 
•    Perform miscellaneous projects and duties at the direction of Sterility Assurance Management.
•    Adhere to and ensure the compliance of Teleflex Medical Code of Conduct, all company policies, rules, procedures, and housekeeping standards.
 

Education / Experience Requirements

•    B.S. Degree in Biology, Chemistry, Microbiology, or other related science, or Engineering with strong chemistry or biology background and 3-5 years of experience in sterilization of medical devices. Msc. Qualification preferable but not essential.

Specialized Skills / Other Requirements

•    Knowledge / experience in EO and gamma radiation sterilization
•    Regulatory, cGMP, QSR knowledge base
•    Statistical knowledge (DOE, SPC, Sample comparison, etc.)
•    Supplier audit skills
•    Strong communication skills (written and verbal)
•    Ability to communicate and operate effectively with multiple teams.
•    Negotiation and strong problem-solving skills
•    Computer literate (MiniTab, Word, Excel, etc.)
•    Ability to adapt to shifting priorities, work with minimal supervision, resolve problems/conflicts, and demonstrate solid reasoning. 

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Working Conditions / Physical Demands

TRAVEL REQUIRED: up to 30%

WORKING ENVIRONMENT:
☒ Office/Professional        ☒ Plant/Manufacturing    ☐ Remote/Field     ☐ Laboratory