The Sterilization Control Assurer will be responsible of sterilization validations, cycles maintenance, sterilization cycle evaluation, product adoption  and ensuring compliance to the applicable methods and regulatory standard requirements.

What you will do

• Assure and enforce compliance to sterilization controls regulatory requirements as they relate to the production and release of sterile products.
• Continuously fully complies with all regulatory and quality system requirements.
• Ensure that the appropriate documentation and procedures are established and reviewed as per latest regulatory requirements to assure compliance to the sterilization control sub-system and requirements set for the Environmental Controlled Areas.
• Effectively follow up to interactions of all control and monitoring processes/programs within the Sterilization Controls sub-system elements as defined above to assure product sterility.
• Effectively follow up to interactions of all control and monitoring processes/programs within the ECA to assure compliance to regulatory requirements.
• Effectively follow up on all documentation related to final product release.
• Monitor the state of the Sterilization Controls sub-system, the Environmental Controlled Areas, Batch Record Review and Product Disposition through tracking and trending, monthly reports and product/system audits as applicable and identifying areas of opportunity and possibilities for growth.
• Ensures regulatory compliance by evaluating proposed changes as they relate to the Sterilization Controls requirements.
• Conducts & documents sterilization controls, environmental controlled areas and Product disposition related investigations as needed.
• Employee has authority to recommend and initiate preventive and corrective action with regard to product non-conformance’s and quality system activities as they relate to the Sterilization Controls sub-system elements, Environmental Controlled Areas and Product Disposition

What you need

• B.S. in Science or related discipline (biology or microbiology preferred).
• Thorough understanding of QSR, ISO 13485, and other applicable medical device regulations, plus sterilization controls related standards (e.g. ISO 11135, 11137, 14644, 10993).
• Highly Desirable:
  • Formal Sterilization and Toxicity Training
  • Lean Six-Sigma, Certified Lead Auditor, Risk Management
  • Formal studies in Education and Teacher License -or- Train the Trainer certification.
• 3-5 years in Quality or Compliance related functional area in FDA regulated environment.
• Solid previous clean room and/or EO/Gamma sterilization technology experience.
• Extensive experience conducting and documenting non conformance investigations.
• Microbiology and sterility testing execution skills and high level proficiency in sterilization controls related matters.