QC Analyst

Alltech Consulting Services; Durley; On-site; GBP 35,000 - 50,000; Full time

Job summary

A leading biotech CDMO is looking for an Environmental Monitoring specialist responsible for testing and monitoring in cleanroom environments. Ideal candidates will have an Associate's degree in Life Sciences, two years of experience in cGMP cleanrooms, and proficiency in Microsoft tools. This role requires strong attention to detail and flexibility to meet campaign demands.

Qualifications

• 2 years of relevant experience in cGMP cleanrooms.
• Proficiency in conducting bioburden and membrane filtration testing preferred.

Responsibilities

• Conduct environmental monitoring in classified cleanrooms.
• Testing of utilities and maintaining quality control standards.
• Collaborate with QA to resolve quality issues.

Skills

Attention to detail

Environmental Monitoring

Quality Control

Education

Associates degree in Life Sciences

Tools

Microsoft Excel

Microsoft Word

LIMS

MODA

Job description

Social network you want to login/join with:

Job Description

Paragon Gene Therapy is a growing Biotech Contract Development and Manufacturing Organization (CDMO) with an internationally recognized tradition of quality and service. Paragon Bioservices provides process development and GMP manufacturing services for Phase I/II clinical trials to industry leaders as well as innovative start-ups utilizing novel technologies to produce state-of-the-art vaccines and therapies for people when they are most in need.

As a Paragon employee, you will actively contribute to the delivery of our services and products to our customers and their patients. This role is responsible for Environmental Monitoring sampling, analyzing, and aseptic monitoring and microbiological testing to support Phase I/II GMP manufacturing. You will work in a fast-paced environment supporting the quality control department of a CMO for manufacturing of biologic bulk drug substance, sterile finished drug product, and fill/finish.

Key Responsibilities include but are not limited to:

1. Primary responsibility is in Environmental Monitoring in classified cleanrooms. Monitoring of surfaces, air, and non-viable air quality of ISO 5, 7, and 8 cleanrooms.
2. Conduct testing of utilities such as USP water, clean steam, and other manufacturing environments (air, surfaces).
3. Build credibility within the lab group by performing high-quality work.
4. Work closely with manufacturing and QA to coordinate routine EM, changeover EM, and monitoring to support client campaigns.
5. Perform media fills and fill/finish monitoring, including continuous monitoring of air quality, personnel aseptic technique, and environment integrity.
6. Act as Quality Control authority for aseptic flow and behavior within cleanrooms.
7. Utilize MODA to enter, compile, and trend environmental data for reporting purposes.
8. Collaborate with Manufacturing and Quality Assurance staff to resolve quality issues related to the facility.
9. Communicate results of work through discussions and documentation, with some input from supervisor.
10. Maintain flexibility to follow unique campaign requirements, which may include off-hour and weekend work.
11. May conduct bioburden and membrane filtration testing on cleaning, in-process, and release samples.

Experience & Education:

• Associates degree in a Life Sciences discipline and 2 years of relevant experience working in cGMP cleanrooms.
• Experience working in cGMP Quality Control.
• Proficiency with Microsoft Excel and Word.
• Strong attention to detail.
• Familiarity with Good Manufacturing Practices (cGMPs).
• Knowledge and ability to apply basic scientific and regulatory principles to solve operational and routine quality tasks.
• Ability to work off hours or weekends as required.
• LIMS or MODA experience is a plus.
• Experience conducting bioburden and membrane filtration testing is a plus.