What are the responsibilities and job description for the Quality Control Analyst position at Infojini Inc?
Job Title – QC Analyst
Location – Winchester KY 40391
Duration – 3 months contract to hire position
Shift Time – SAT, SUN, MON 6AM - 6PM AND BIWEEKLY TUES 6AM - 2:30PM
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
