Leading Biotech Research company is searching for a Sterility Assurance Specialist to join their team to support scientific research performed as part of preclinical Research and Development.

Type

Contract to hire (6 month)

Schedule

1st shift Monday-Friday (9a-5p)

$30-$40 / hr

The Sterility Assurance Specialist is responsible for maintaining sterility assurance processes and ensuring compliance with industry standards and regulations.

Requirements :

• Bachelor’s degree in microbiology or related field (advanced degrees are advantageous).
• Minimum of 2 years of experience in sterility assurance or related roles.
• Strong knowledge of FDA regulations and industry standards.
• Excellent communication and collaboration skills.

Responsibilities :

Technical Expertise :

• Be a subject matter expert in sterility assurance in interactions with regulatory bodies (such as the FDA), notified bodies, and customers.
• Develop responses to microbiology and sterilization-related requests and audit findings.

Risk Assessment and Root Cause Analysis :

• Conduct risk assessments related to sterility assurance and microbiology.
• Perform root cause analyses for sterility assurance, environmental monitoring, and other microbiology-related issues.
• Develop corrective and preventive actions to address identified risks.

Compliance and Standards :

• Maintain compliance with relevant regulations (e.g. 21 CFR Part 210 / 211).
• Ensure adherence to industry standards and best practices.
• Collaborate with internal and external stakeholders to align processes with guidelines.

Quality Control and Audits :

• Regularly audit personnel and processes for bioburden control and sterility assurance.
• Manage and evaluate ISO classification activities, media fills, and gowning validation processes
• Perform trending and analysis of environmental monitoring and other microbiological data for management review and continuous improvement

Team Leadership and Training :

• Provide guidance, training, and support as needed to operators in support of aseptic and sterile operations.
• Foster a culture of quality and compliance within the team

Work Environment :

• Work in office and clean room environments
• On site in Brownsburg, IN, with travel up to 10% to Plano, TX

Last updated : 2024-06-25