Sterility Assurance Specialist
hace 1 semana
The Sterility Assurance Scientist at Viant Medical plays a pivotal role in ensuring the highest quality of medical devices by providing support to sterilization projects and programs. This position involves managing and supervising processes such as sterilization validation protocols, sterilization assessments, dose audits, and sterilization failure investigations, all while maintaining compliance with ISO 13485:2018 and 21 CFR 820.
Key Responsibilities:
- Develop and implement product sterilization methodologies across multiple sites in support of legacy products and NPI programs.
- Maintain a deep understanding of various sterilization methods and types, including medical devices, pharmaceuticals, and combination devices.
- Lead the supplier/vendor selection process for sterilization and conduct onsite/remote supplier audits.
- Author sterilization assurance validation protocols and reports in conjunction with contract sterilizers and labs, adhering to customer requirements.
- Create and implement test methods to evaluate and ensure the safety of sterilized products.
- Develop written procedures to control routine sterilization processing.
- Provide training and guidance to site-level personnel and document training in accordance with site procedures.
- Identify and elevate opportunities for preventive and corrective action, assist in implementing proactive programs that are plant-specific and corporate-wide in sterilization/microbial control.
- Monitor change control of products, product transfers, processes, and facilities with regard to impact on sterilization and microbial control, through document change requests, audits, and project participation.
- Create project plans, timelines, and budgets to ensure sterilization project goals are achieved, communicating progress and escalations to the executive team and site leadership.
- Maintain a complete understanding and compliance with FDA, OSHA, EPA, and Viant Medical mandates regarding sterilization, microbiological quality control, and medical products manufacturing environments.
- Ensure state-of-the-art methodology and results using documented procedures, equipment, and accept/reject criteria of sterilization process and validation testing.
- Establish and maintain a routine internal audit program, as well as evaluation/audit of contract sterilizers and laboratories, in conjunction with other business units.
- Conduct or participate in customer and regulatory body audits.
- Interface between the laboratory and other areas of the company to ensure test reports are clearly written and understood.
Requirements:
- Bachelor's Degree in Engineering, Microbiology, Biology, or equivalent.
- Minimum 2 years of work experience within the medical device or pharmaceutical industry in Medical Devices Sterilization, Sterility assurance, and product testing.
- Knowledge of GMPs, ISO, USP, and FDA regulations as they relate to laboratory operations and investigations and sterilization.
- 25% travel.
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