Quality Sterilization Analyst

Position:
Quality Sterilization Analyst

Location:
Sandy, UT

Duration: 6‑12 month position, with potential for permanent role.

Total Hours/week: 40.00

1st Shift

Primary responsibilities for a Quality Sterilization Analyst will include supporting a broad range of activities to maintain the sterilization assurance program. Work with the sterilization team to support new product development and validation activities. Support these activities with the necessary preparation, quality assurance, and documentation.

• Support the sterilization requalification and radiation dose audit programs to ensure continuity of validated processes.
• Coordinate 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.
• Ensure that testing and documentation are performed according to GMP and GDP practices.
• Schedule, conduct, document, and communicate the results of sterilization and microbiology laboratory tests.
• Ensure that product is tested in a timely manner, minimizing any impacts to production scheduling.
• Perform analysis of sterilization parameters for product release and sterilization validations.
• Conduct product release (EO & Gamma).
• Participate as a member of special project teams, as assigned, including support of sterilization, QC microbiology, R&D and plant objectives.
• Maintain metrics within sterilization in order to promote continuous improvement.
• Monitor reagents and materials to avoid testing delays.
• Assist in training of new employees, as assigned.
• Ensure that good housekeeping practices are followed in the area and participate in scheduled lab cleaning and maintenance activities.
• Review raw data, procedures, controls, and final reports for completion and accuracy.
• Provide knowledgeable representation during laboratory audits.
• Author and revise SOPs utilizing an SAP document management system.
• Comply with all local, state, federal, and BD safety regulations, policies, and procedures including RCRA Hazardous waste regulations.
• Comply with all local BD quality policies, procedures, and practices through consistent application of sound quality assurance principles.
• Other duties as assigned.

• 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) year of relevant lab experience.
• Must be able to lift and/or move up to 45 pounds.

• 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.