Job Title – QC Analyst

Location – Winchester KY 40391

Duration – 3+ months contract position

Shift Time – MON-FRI 11PM - 7:30AM OR SAT, SUN, MON 6AM - 6PM AND BIWEEKLY TUES 6AM - 2:30PM OR MON-FRI 3PM - 11:30PM

Role Description:

• Client 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. Works in a fast-paced environmental supporting the quality control department of a CMO for manufacturing of biologic bulk drug substance, sterile finished drug product, and fill/finish.

Job Roles and responsibilities

• 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.
• Conducts testing of utilities such as USP water, clean steam, and testing of other manufacturing environments (air, surfaces)
• Builds credibility within the lab group by performing high quality work
• Works closely with manufacturing and QA to coordinate routine EM, changeover EM, and monitoring to support client campaigns
• Performs media fills and fill/finish monitoring which includes continuous monitoring of air quality, personnel aseptic technique, and environment integrity
• Acts as Quality Control authority for aseptic flow and behavior within cleanrooms
• Utilizes MODA to enter, compile, and trend environmental data for reporting purposes
• Works closely with Manufacturing and Quality Assurance staff to resolve quality issues with regard to the facility
• Effectively communicates results of own work through discussions and documentation with some input from supervisor
• Flexibility in following unique campaign requirements that may include off-hour and weekend work
• May conduct bioburden and membrane filtration testing on cleaning, in-process and release samples.

Minimum Qualifications & Experience

• Associates degree in a Life Sciences discipline and 2 years of relevant experience working in cGMP cleanrooms
• Experience working in cGMP Quality Control
• Experience with Microsoft Excel and Microsoft Word
• Strong attention to detail
• Familiarity with Good Manufacturing Practices (cGMP’s)
• Have the knowledge and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasks
• Must be able to work off hours or weekends as required
• LIMS or MODA experience a plus
• Experience conducting bioburden and membrane filtration testing a plus

Company Overview:

Infojini Consulting is a Staffing and Recruitment company and incorporated in Baltimore, MD.

• Infojini caters various hospitals, health & wellness centers, pharmacy, and medical facilities over fifty states across the United States