Quality Sterilization Analyst

Responsibilities

• Support the sterilization requalification and radiation dose audit programs to ensure continuity of validated processes.
• Cook up yearly and quarterly product re-verifications (Irradiation & Ethylene Oxide).
• Perform routine analysis of EO/ECH residual testing of terminally sterilized medical using gas chromatography (GC-FID).
• Support routine quality control testing of medical device. This can include (but not limited to): bio burden testing, sterility testing, endotoxin testing, enumeration, and environmental monitoring.
• Ensures that testing and documentation are performed according to GMP and GDP practices.
• Schedules, conducts, documents, and communicates the results of sterilization and microbiology laboratory tests.
• Ensures that product is tested in a timely manner, minimizing any impacts to production scheduling.
• Performs analysis of sterilization parameters for product release and sterilization validations.
• Conducts product release (EO & Gamma)
• Participates as a member of special project teams, as assigned, including support of sterilization, QC microbiology, R&D and plant objectives.
• Maintains metrics within sterilization in order to promote continuous improvement.
• Responsible for monitoring reagents and materials to avoid testing delays.
• Affords assistance in training of new employees, as assigned.
• Maintains good housekeeping practices in the area and participates in scheduled lab cleaning and maintenance activities.
• Reviews raw data, procedures, controls, and final reports for completion and accuracy.
• Ability to provide knowledgeable representation during laboratory audits.
• Authors and revises SOPs utilizing an SAP document management system.

Qualifications

• Required High School Diploma, or equivalent, with three (3) years relevant experience working in a laboratory environment or a combination of relevant experience and education (i.e. semester hours in a scientific discipline).
• Or Associate degree, AS, in a scientific discipline with one (1) years relevant lab experience.
• Must be able to lift and/or move up to 45 pounds.

Additional Preferred Skills And Qualifications

• Experience with Empower, Lab Ware, and SAP (preferred).
• Class I / II medical device experience (preferred).
• Experience with microbiology and sterilization related standards (e.g. ISO/ANSI/AAMI 11135, ISO-11737, ISO 10993-7)
• Strong computer literacy (Excel, Word, etc.)
• Ability to define, organize, and manage individual tasks
• Effective verbal and written communication skills
• Interpersonal skills; working in a team and as an individual contributor