What are the responsibilities and job description for the QC Analyst position at System One?
Title: QC Analyst
Shift: MON-FRI 3PM - 11:30PM
Location: Winchester KY
P ay rate: $29.08
Start: ASAP thru June 2025
Education:
• Associates degree in a Life Sciences discipline
Requirements:
2 years of relevant experience working in cGMP cleanrooms
• Experience working in cGMP Quality Control
• Experience with Microsoft Excel and Microsoft Word
• 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
PLUS:
• LIMS or MODA experience a plus
• Experience conducting bioburden and membrane filtration testing a plus
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)
• 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
• May conduct bioburden and membrane filtration testing on cleaning, in-process and release samples.
#m3
Shift: MON-FRI 3PM - 11:30PM
Location: Winchester KY
P ay rate: $29.08
Start: ASAP thru June 2025
Education:
• Associates degree in a Life Sciences discipline
Requirements:
2 years of relevant experience working in cGMP cleanrooms
• Experience working in cGMP Quality Control
• Experience with Microsoft Excel and Microsoft Word
• 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
PLUS:
• LIMS or MODA experience a plus
• Experience conducting bioburden and membrane filtration testing a plus
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)
• 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
• May conduct bioburden and membrane filtration testing on cleaning, in-process and release samples.
#m3
Salary : $29
