Quality Control Analyst II

Overview:

The Quality Control Analyst II will report directly to the QC Lead and will primarily support activities for the site including collection of Environmental Monitoring (EM) data and trending of the ISO clean rooms as well as Reverse Osmosis Deionized (RODI) water collection and analysis. The analytical activities supporting this role include microbial testing e.g. bioburden testing, endotoxin analysis, and microbial identifications. The candidate will actively follow Repligen ISO 9001 Quality Management System in support of all manufacturing activities, including additional laboratory compliance as assigned by QC Management.
Responsibilities:

• Performs testing of cassettes and documents results for release (bioburden and endotoxin).
• Performs microbial identifications and establishment of microorganism libraries for all Repligen sites.
• Carries out environmental monitoring of ISO controlled environments.
• Performs RODI water collection and testing.
• Trends data collected during all QC testing.
• Writes, reviews and assists with quality events such as deviations, corrective actions and non-conformances.
• Reviews data performed by peer.
• Assists with OOS investigations associated with QC testing.
• Maintains laboratory and laboratory supplies.
• Performs site gowning training and qualifications as needed.

Qualifications:

• Requires BA/BS level education in Biology or related field and minimum of 2-5 years’ experience in Quality Control laboratory or equivalent.
• Experience with environmental monitoring and/or water collection.
• Ability to work independently once training has been completed.
• Familiarity with SAP and Canea One is preferred.
• Ability to communicate with multiple departments and analyst.
• Applies a high level of precision to all aspects of daily activities.
• Ability to work efficiently in an ISO 9001 quality system with appropriate attention to detail in the performance of controlled procedures.
• Good understanding of the critical utilities a plus.
• Experience in the following a plus: Microbiological assays (pH, conductivity, bioburden, endotoxin, microbial identification) and aseptic technique.

Regularly required to bend, reach, stand, walk or sit daily.
Must be able to regularly lift 20+ pounds.