QC Analyst (Biotechnology Environmenatl Monitoring)
Job Title: QC Analyst (Biotechnology Environment)
Location: Kentucky, USA (Open for local candidates within a 50-mile radius)
Positions: 4
Employment Type: Contract-to-Hire (First 4 months by contract)
Shifts:
- Monday - Friday, 3:00 PM - 11:30 PM
- Saturday, Sunday, Monday 6:00 AM - 6:00 PM, and Biweekly Tuesday 6:00 AM
- Monday - Friday, 3:00 PM - 11:30 PM - 2:30 PM
Duration: Approximately 4 months
Job Summary:
Our client, a growing Biotech Contract Development and Manufacturing Organization (CDMO), specializes in providing process development and GMP manufacturing services for Phase I/II clinical trials. They partner with industry leaders and innovative startups to develop state-of-the-art vaccines and therapies. As a QC Analyst, you will play a key role in ensuring quality control through environmental monitoring and microbiological testing to support GMP manufacturing. This is a fast-paced environment supporting the production of biologic bulk drug substances, sterile finished drug products, and fill/finish operations.
Key Responsibilities:
- Perform Environmental Monitoring (EM) in classified cleanrooms, including ISO 5, 7, and 8 environments.
- Monitor surfaces, air, and non-viable air quality to ensure compliance with GMP regulations.
- Conduct utility testing for USP water, clean steam, and air/surface samples in manufacturing environments.
- Work closely with Manufacturing and QA to coordinate routine EM, changeover EM, and client-specific monitoring requirements.
- Execute media fills and fill/finish monitoring, including continuous air quality assessment, personnel aseptic technique evaluation, and environmental integrity verification.
- Act as a Quality Control authority for aseptic flow and behavior within cleanrooms.
- Utilize MODA for data entry, compilation, and trending of environmental monitoring results.
- Assist in identifying and resolving quality issues related to facility operations in collaboration with Manufacturing and QA teams.
- Communicate test results and findings effectively through documentation and discussions.
- Demonstrate flexibility in adapting to unique campaign requirements, including off-hour and weekend work when necessary.
- Conduct bioburden and membrane filtration testing on cleaning, in-process, and release samples as needed.
Qualifications & Experience:
- Associate’s degree in Life Sciences or related field with at least 2 years of relevant experience in cGMP cleanroom environments.
- Hands-on experience in cGMP Quality Control operations.
- Proficiency in Microsoft Excel and Word for documentation and reporting.
- Strong attention to detail and ability to follow strict regulatory guidelines.
- Knowledge of Good Manufacturing Practices (cGMPs) and regulatory compliance standards.
- Ability to apply scientific and regulatory principles to operational and quality tasks.
- Willingness to work off-hours or weekends as required.
- Experience with LIMS or MODA is a plus.
- Prior experience conducting bioburden and membrane filtration testing is a plus.
How to Apply:
If you meet the qualifications and are interested in this opportunity, please submit your updated resume for consideration. We look forward to reviewing your application!