Sterilization Assurance Specialist Role

hace 1 día

Paraíso, Paraíso, Costa Rica Nextern A tiempo completo

This position is a pivotal part of ensuring that sterilization and product final release meet customer and regulatory expectations. The Sterilization Assurance Specialist will strategically manage sterilization requirements between Nextern, Sterilization Suppliers, and key clients to guarantee compliance with business procedures and requirements.

The role actively maintains and implements process improvements in products and development programs to ensure they are carried out efficiently and effectively. This involves collaborating closely with project managers, production personnel, quality assurance specialists, supply chain professionals, process development engineers, and other supporting roles within Nextern sites as well as with the Sr. Sterilization Assurance Engineer.

At all levels, quality roles are expected to support and promote EHS safety initiatives and general programs site-wide, following all GxP as per Nextern policies, practices, and procedures to ensure compliance with FDA and ISO regulations, as well as Nextern quality standards. This also includes supporting SGC processes in all functions across Nextern.

Main Responsibilities
  • Determining if bioburden testing is required per the Working Instruction (WI) and preparing samples from batches by selecting samples and labeling them according to the Material Procedure (MP)/Working Instruction (WI).
  • Determining the quantity of endotoxin samples needed (if required per WI) and preparing samples from batches.
  • Completing Test Request Forms as per WI: sterility TRF, endotoxin TRF, bioburden TRF, and microbiological services TRF.
  • Reviewing cycle run data for accuracy and compliance.
  • Trending bioburden and endotoxin results to identify any deviations or areas for improvement.
  • Preparing sterile release travelers to ensure seamless product delivery.
  • Preparing samples/pallets for Biennial MPQ/PPQ Runs to maintain consistency and quality.
  • Developing Routine Sterilization Monitoring Plans to proactively identify and address potential issues.
  • Creating Sterile Prep Work Instructions to standardize procedures and improve efficiency.
  • Collaborating with Quality on creating sterile release travelers to ensure alignment and compliance.
  • Analyzing annual reviews to identify trends and areas for improvement.
  • Conducting Biennial MPQ/PPQ Runs to assess product quality and compliance.
  • Evaluating the impact of design changes on sterility and implementing corrective actions as necessary.
  • Supporting Micro ISO Audits to ensure adherence to industry standards and regulations.
Requirements
  • A university degree in Life Sciences, Engineering, or Microbiology.
  • At least two years of experience in Sterilization activities in regulated industries such as Medical Devices and Pharmaceutical.
  • An advanced level of English proficiency (B1+, C1 Belt).
  • Demonstrated high-level competencies in accountability, teamwork, effective communication, and advanced planning and organizing skills.
Benefits

Nextern offers a competitive compensation package and an exceptional working environment that fosters growth and development.

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