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Quality Assurance Specialist

1 week ago


Winchester, Kentucky, United States Aditi Consulting Full time
Job Description
At Aditi Consulting, we are seeking a highly skilled Environmental Monitoring Expert to join our team. As an Environmental Monitoring Expert, you will be responsible for ensuring the quality and integrity of our cleanrooms by performing environmental monitoring in classified areas, including surface, air, and non-viable air quality assessments in ISO 5, 7, and 8 environments.

Responsibilities:
- Perform environmental monitoring in classified cleanrooms, including surface, air, and non-viable air quality assessments in ISO 5, 7, and 8 environments.
- Conduct utility testing, including USP water, clean steam, and other manufacturing environments.
- Collaborate with manufacturing and QA teams to coordinate routine environmental monitoring (EM), changeover EM, and monitoring for client campaigns.
- Participate in media fills and fill/finish monitoring, ensuring continuous assessment of air quality, personnel aseptic techniques, and environmental integrity.

Requirements:
- Associate's degree in a Life Sciences discipline.
- Minimum of 2 years of relevant experience working in cGMP cleanrooms.
- Experience in cGMP Quality Control.
- Proficiency in Microsoft Excel and Microsoft Word.
- Strong attention to detail.
- Familiarity with Good Manufacturing Practices (cGMP).
- Ability to apply basic scientific and regulatory principles to operational and quality tasks.
- Availability to work off-hours or weekends as needed.
- Experience with LIMS or MODA is a plus.
- Experience in bioburden and membrane filtration testing is a plus.

Benefits:
- Competitive salary range of $27.00 - $27.76 per hour.
- Opportunities for professional growth and development.
- Collaborative and dynamic work environment.
- Recognition and rewards for outstanding performance.

About Us:
Aditi Consulting is a leading provider of consulting services to the life sciences industry. We are committed to delivering high-quality solutions that meet the evolving needs of our clients. If you are a motivated and experienced professional looking for a new challenge, we encourage you to apply.