2 Jobs in Brownsburg, IN
Orano Med is Hiring a Sterility Assurance Specialist Near Brownsburg, IN
Key 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.
- 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.
- 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.
- 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
- 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.
- 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.
- Work in office and clean room environments
- On site in Brownsburg, IN, with travel up to 10% to Plano, TX
Find out more about Orano Med
Job Summary
Full Time
Contract Research
$34k-43k (estimate)
04/27/2024
06/19/2024
arevamed.com
Plano, TX
<25
Contract Research
Related Companies
The job skills required for Sterility Assurance Specialist include Aseptic Technique, Leadership, Collaboration, etc. Having related job skills and expertise will give you an advantage when applying to be a Sterility Assurance Specialist. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Sterility Assurance Specialist. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Sterility Assurance Specialist positions, which can be used as a reference in future career path planning. As a Sterility Assurance Specialist, it can be promoted into senior positions as a Central Supply Supervisor that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Sterility Assurance Specialist. You can explore the career advancement for a Sterility Assurance Specialist below and select your interested title to get hiring information.
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