Job Information
Astrix Technology Sterility Assurance Specialist in Indianapolis, Indiana
Sterility Assurance Specialist
Laboratory
Indianapolis, IN, US
Pay Rate Low: 30 | Pay Rate High: 40
- Added - 14/06/2024
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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 : 1 st shift Monday-Friday (9a-5p)
Pay : $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:
Provide technical expertise in bioburden reduction methods, including aseptic techniques, cleaning, and disinfection practices.
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
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.