INTERESTED IN THIS ROLE? Apply TODAY for immediate consideration to Grace at grawilliams @actalentservices.com with an updated resume!

Overview: We are seeking a detail-oriented Sterility Assurance Specialist to join our team. The ideal candidate will have a background in laboratory work, aseptic environments within a pharmaceutical or radiopharma, and possess knowledge of FDA regulations. The Sterility Assurance Specialist is responsible for maintaining microbiology and 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.

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.

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 3 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

This position offers an exciting opportunity for individuals with a passion for scientific research and laboratory work. Join us in our mission to maintain high standards of sterilization practices in support of cutting-edge research initiatives to excel in your career for growth opportunities.

INTERESTED IN THIS ROLE? Apply below today, ASAP!

• I am actively hiring and interviewing for this position and I will be conducting phone interviews as early as today. All candidates will be considered immediately and bypass the HR process to be in consideration within 24 hours of applying and reaching out directly TODAY to Grace Williams.
• HOW TO APPLY: Email your updated resume, brief intro about your interest, what method of communication works best for you (i.e., call, email, text) to grawilliams@actalentservices. com or call (317-567 -6610)

Job Type: Full-time

Pay: $38.00 - $41.00 per hour

Expected hours: 40 per week

Benefits:

• 401(k)
• Dental insurance
• Employee assistance program
• Employee discount
• Flexible schedule
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Professional development assistance
• Retirement plan
• Vision insurance

Schedule:

• 4 hour shift
• 8 hour shift
• Day shift
• Monday to Friday
• No nights
• No weekends

Application Question(s):

• What experience do you have working within clean rooms or an aseptic environment (pharma, with Sterile Liquid Injectables being the most relevant)
• Explain your Sterility/Microbiology experience (Bioburden, environmental monitoring, aseptic technique, media fills, etc.)

Experience:

• Sterility/Microbiology: 4 years (Required)

Work Location: In person