- Degree: BS or MS Degree in Micro, Bio, etc.
- Years of Exp: 2+ years of sterility
- EM Program oversight - understand the requirements for Sterile Injectable
- Industry: Sterile Injectable pharma exp with aseptic techniques
- Skills: Bioburden, CAPAs, Root Cause, and Auditing exp
- The Sterility Assurance Specialist is responsible for maintaining sterility assurance processes and ensuring compliance with industry standards and regulations. They collaborate with cross-functional teams to develop and implement bioburden reduction strategies, perform risk assessments, and address microbiology-related issues.
- 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.
- Qualifications:
- 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 Environment:
- Work in office and clean room environments
- On site in Brownsburg, IN, with travel up to 5% to Plano, TX (twice a year)
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Sterility Assurance Manager-226305 - Brownsburg, United States - Medix™
Description
HIRING Sterility Assurance Manager Medix Life Sciences is the fastest growing staffing organization specializing in Clinical Research and Life Sciences placements for all the major health systems and research organizations throughout the country. Medix is looking for an candidate with a BS or MS degree and 2+ years of experience in Sterility Assurance
Requirements:
Position Summary: Location: Brownsburg, IN 46112 Pay: 70-85k depending on experience Hours: M-F 9am-5pm before starting production, then move to 2pm-10pm Sun-Thurs
Position Description:
Qualified candidates are encouraged to applyWe would love to discuss these positions with you further
