Sterility Assurance Specialist III

Company: Integrated Resources, Inc
Location: Alpharetta
Posted on: March 17, 2023

Job Description:

Duration:0-6 month(s)

Description/Comment:To provide technical expertise in the terminal sterilization sciences for medical devices products. These activities include but are not limited to: Support with coordination and development activities for terminal sterilization methods (ethylene oxide, gamma/E-Beam irradiation) required to support medical product manufacturing. Provide sterilization sciences expertise and validation subject matter expertise in support of product design and product and/or material changes. Ensure compliance to quality system and sterilization standards requirements ISO 13485, ISO 11135 and ISO 11137. Support with SA assessment for new business acquisition.
Product:
The incumbent reports to the Manager Sterility Assurance. He/she provides technical expertise within the company for supporting activities related to: validations and requalifications following ISO 11135 and ISO 11137, training implementation for knowledge in ISO 11135 and ISO 11137, integration of standards operating procedures related to sterility assurance. Integration / Gap assessment / Remediation for new business acquisitions.
Sterilization Sciences Leadership:
Work within cross functional teams to support: Validation requirements for new materials/products, specifically focus on material compatibility, microbial controls required and qualification activities for new product/process sterilization validations. Lead and ensure validation actions are compliant to all international sterilization standards and meet all regulatory compliance requirements for sterile products.
Deliverables, Responsible for support:
Sterilization Validation Protocol. Sterility Assurance Assessments. Sterilization Specifications. New Contract Sterilizer Quality Plan. Protocols and Validation Reports Sterilization Specifications. Training.
Education:
B.S in Microbiology, Engineering, or Sciences. Extensive knowledge of various modes for terminal sterilization, Regulatory requirements, material compatibilities, validation requirements and all related sterility assurance activities for medical devices. Knowledge and experience with ISO Sterilization Standards, Medical device GMPs.

Additional Job Details:Looking for a contractor resource (assignment will be for about 6 months); the candidate should have some knowledge of microbiology and sterilization techniques for medical devices (EO and Radiation gamma preferably), also general Quality Management System knowledge. 1. To support implementation of Sterility Assurance Quality System program 2. To support with development of protocols and reports for sterility assurance studies 3. To support with development of reports for microbiology studies

Keywords: Integrated Resources, Inc, Alpharetta , Sterility Assurance Specialist III, Other , Alpharetta, Georgia