What are the responsibilities and job description for the Quality Control Associate - Environmental Monitoring position at Intellectt Inc?
Role: Quality Control Associate - Environmental Monitoring
Location: Winchester KY/100% Onsite role
Duration: 4 months
The role focuses on Environmental Monitoring (EM), microbiological testing, and aseptic monitoring to support GMP manufacturing of biologic drug substances and sterile products.
Key responsibilities include:
- Monitoring air, surfaces, and non-viable air quality in cleanrooms (ISO 5, 7, 8).
- Testing utilities such as USP water and clean steam.
- Coordinating EM activities with manufacturing and QA teams.
- Performing media fills, fill/finish monitoring, and ensuring aseptic techniques.
- Compiling and trending environmental data using MODA.
- Communicating findings and addressing quality issues with stakeholders.
Requirements:
- Associates degree in Life Sciences and 2 years of cGMP cleanroom experience.
- Familiarity with cGMP, Excel, and MODA/LIMS .
- Strong attention to detail and ability to work flexible hours when required.
