QC Analyst II with HPLC - Waltham, MA | Biospace
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QC Analyst II with HPLC

Repligen Corporation

Waltham, MA
Posted Date:
Position Type:
Full time
Job Code:
Required Education:
Associates Degree
Areas of Expertise Desired:
Analyst, HPLC, QC,

Job Description

Essential Duties and Responsibilities:

The QC Analyst will report directly to the QC Manager and will be primarily responsible for performing in-process testing of Repligen Bioprocessing ligands, and release of OPUS pre-packed chromatography columns.   The analytical activities supporting this position include HPLC, SDS-Page, FTIR analysis and microbial testing (bioburden & endotoxin). The successful candidate will support activities for facilities including collection of Environmental Monitoring data in the ISO clean rooms as well as RODI collection and analysis.  The candidate will actively follow Repligen ISO 9001 Quality Management System in support of the Bioprocessing manufacturing processes and final product testing, including additional laboratory compliance as assigned by the QC Manager.


•   Performs final testing of finished OPUS® pre-packed chromatography columns and documents results for product release (bioburden and endotoxin)
•   Performs in-process concentration analysis by UV and HPLC
•   Performs sample preparation for FTIR analysis
•   Perform ELISA testing
•   Perform RODI water testing
•   Carries out monitoring of ISO controlled environments and records data for trend analysis
•   Writing and reviewing SOPs, writing deviations, reviewing data of peer reviews
•   Assists with OOS investigations and change controls associated with QC testing


Education and/or Work Experience Requirements:

•   Requires college level education in Biology or related field and 4-8 years’ experience in Quality Control laboratory or equivalent
•   Ability to work independently once training has been completed
•   High attention to detail applied to all aspects of daily activities
•   Ability to work efficiently in an ISO 9001 quality
•   Strong HPLC experience and a good understanding of the fundamentals of column chromatography
•   Experience with microbiological assays (Environmental monitoring, water testing, bioburden, endotoxin)
•   Experience with ELISA
•   Gel electrophoresis
•   FTIR (Fourier Transform Infrared Spectroscopy)