This position is responsible for tactically managing sterilization requirements between Nextern, Sterilization Supplier and key clients in the business. The Sterilization Assurance Specialist will ensure that sterilization and product final release customer and regulatory expectations are met before and after sterilization process and product release.
This role shall actively maintain and implement process improvements in products and development programs so that they are carried out in an appropriate and timely manner, according to Nextern business procedures and requirements. This role will actively interact with project managers; production, quality assurance, and supply chain personnel; process development engineers; and other supporting roles at Nextern sites, but also with Sr. Sterilization Assurance Engineer. At all levels, the roles in quality are expected to support, promote, and enforce EHS safety and general initiatives and programs site wide; follow all GxP as per Nextern policies, practices, and procedures to ensure compliance with FDA and ISO regulations, as well as with Nextern quality standards and support SGC processes in all functions across Nextern.
**Main responsibilities**
- Responsible for determining if bioburden testing is required per the WI and preparing samples from batch (select samples from batch and label per MP/WI)
- Responsible for determining quantity of endotoxin samples (if required per WI) and preparing samples from batch
- Responsible for completing Test Requests Forms per WI: sterility TRF, endotoxin TRF, bioburden TRF, and microbiological services TRF
- Responsible for reviewing cycle run data
- Responsible for bioburden and endotoxin trending
- Responsible for sterile release traveler
- Responsible for prepping samples/pallets for Biennial MPQ/PPQ Runs
- Responsible for Routine Sterilization Monitoring Plans
- Responsible for Sterile Prep Work Instructions
- Work with Quality on creating a sterile release traveler
- Responsible for annual reviews
- Responsible for Biennial MPQ/PPQ Runs
- Responsible Sterility impact for design change plans
- Support Micro ISO Audits
**Requirements**:
- University degree in Life Sciences, Engineering, or Microbiology
- Two or more years of experience in Sterilization activities in regulated industries like Medical Devices, Pharmaceutical
- Advanced level of English B1+, C1 Belt
- Demonstrated high level competencies in accountability, teamwork, communicating effectively and advanced planning and organizing skills.
**Benefits**
Competitive compensation package and an exceptional working environment.