Sterility Assurance Technician

Medasource; Durham (NC); On-site; USD 50,000 - 70,000; Full time

Job summary

A leading company in the healthcare sector is seeking a Sterility Assurance Technician for night shifts. The role involves ensuring compliance with sterility assurance protocols, executing routine activities, and collaborating with teams to troubleshoot contamination issues. Candidates should have experience in qualification or validation activities and a strong understanding of aseptic techniques. Excellent communication and organizational skills are essential.

Qualifications

• Experience in qualification or validation activities for contamination control.
• Understanding of aseptic techniques and media fill processes.

Responsibilities

• Participate in qualification and validation activities for bioburden control.
• Analyze environmental monitoring data for product quality.

Skills

Attention to Detail

Organizational Skills

Communication

Job description

Job Title: Sterility Assurance Technician

Schedule: Night shift including weekends, 12-hour shifts on a 2-2-3 rotation. Must be flexible to accommodate additional work in extended hours and/or off-hour work.

Need to come in 8AM-5PM for training, probably the first two weeks, then switch to nights.

Key Responsibilities:

• Participate in qualification and validation activities related to bioburden control strategies for facilities and equipment.
• Execute routine sterility assurance activities.
• Support media fill simulations and provide documentation to ensure compliance with regulatory guidelines.
• Analyze and interpret environmental monitoring data, identifying trends and potential risks to product quality.
• Collaborate with cross-functional teams to troubleshoot contamination events and recommend corrective actions.
• Maintain accurate records and ensure timely reporting of sterility assurance results.

Qualifications:

• Experience in qualification or validation activities supporting contamination control measures in manufacturing facilities or equipment.
• Comprehensive understanding of aseptic techniques, either through hands-on operational experience or involvement in media fill processes.
• Prior experience participating in media fill simulations in a regulated environment.
• Ability to work in a fast-paced environment with strong attention to detail and organizational skills.
• Excellent written and verbal communication skills.

Seniority level:

• Associate

Employment type:

• Full-time

Job function:

• Science

Industries:

• Hospitals and Health Care