QC Analyst at Aditi Consulting

Job Summary:

Paragon Gene Therapy is a growing Biotech Contract Development and Manufacturing Organization (CDMO) recognized for its commitment to quality and service. We provide process development and GMP manufacturing services for Phase I/II clinical trials, supporting both industry leaders and innovative start-ups in producing vaccines and therapies. This role is responsible for environmental monitoring, aseptic monitoring, and microbiological testing to support Phase I/II GMP manufacturing. The position operates in a fast-paced environment within the Quality Control department, supporting the manufacturing of biologic bulk drug substances, sterile finished drug products, and fill/finish operations.

Key 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.
• Serve as a Quality Control authority on aseptic flow and behavior within cleanrooms.
• Utilize MODA for data entry, compilation, and trending of environmental data for reporting.
• Work closely with Manufacturing and Quality Assurance staff to address facility-related quality issues.
• Communicate test results effectively through discussions and documentation with guidance from a supervisor.
• Adapt to unique campaign requirements, including off-hour and weekend work as needed.
• Conduct bioburden and membrane filtration testing on cleaning, in-process, and release samples as required.

Qualifications & Experience:

• 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.

Compensation:

The pay rate range above is the base hourly pay range that Aditi Consulting reasonably expects to pay someone for this position (compensation may vary outside of this range depending on several factors, including but not limited to, a candidate’s qualifications, skills, competencies, experience, location and end client requirements).

Benefits and Ancillaries:

Medical, dental, vision, PTO benefits and ancillaries may be available for eligible Aditi Consulting employees and vary based on the plan options selected by the employee.

Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human-based decision making in employment decisions. By applying to this position, you agree to Aditi’s use of AI technology including calls from an AI Voice Recruiter.

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