| Job Description | uniQure is dedicated to bringing therapies for unmet medical needs to patients. In doing so each function in uniQure is directly or indirectly responsible for the lives of patients. This responsibility should be part of our day-to-day working life (i) by living up to high quality standards and (ii) by recognizing the sense of urgency in areas of high medical need.
The Quality Control (QC) department is responsible for monitoring the quality of our AAV-based products, and the quality of the raw materials and starting materials used. QC is also responsible for execution of the Environmental Monitoring (EM) program in place to monitor uniQure?s manufacturing environment (clean rooms). These activities are all performed in accordance with cGMP guidelines, and are supported by departmental and inter-departmental policies and standard operating procedures.
Summary of Job Description:
The Microbiology Analyst III will be responsible for the performance of the routine QC sampling and testing within the function of the QC Microbiology Laboratory.
Key Responsibilities:
?Assist in establishing of utilities monitoring programs and lab set up.
?Environmental monitoring of the HVAC and utility systems.
?Perform routine QC Microbiology sampling/testing such as bio burden, endotoxin, growth promotion, Gram stain, and microbial identifications, following SOPs.
?Water sampling and associated water testing (such as chemical analysis to include visual appearance, heavy metals, nitrates, pH, conductivity, etc.).
?Sampling and testing of gas supplies to manufacturing suites.
?Trend environmental monitoring data and aid in compilation of trend reports.
?Write and revise SOPs, protocols and technical reports as necessary.
?Review testing data of other QC Analysts, as applicable.
?Complete documentation in accordance with current Good Manufacturing Practices (cGMP).
?Maintain QC Microbiology related systems in compliance with industry standards.
?Raising change controls and deviations related to QC and assisting with non-conformance investigations.
?Coordinate shipment of samples to contract testing laboratories and review of testing data reports.
?Additionally, the analyst will assist in scheduling of the routine QC Microbiology testing and oversee the performance of non-routine / investigational testing performed within the Microbiology Laboratory, as required.
Other Responsibilities:
?Perform laboratory tasks including general housekeeping, equipment monitoring and maintenance, inventory of supplies, etc.
?Troubleshooting equipment and microbiological testing methods.
?Perform QC testing of in-process and product samples following Standard Operating Procedures (SOPs).
?Training of other Analysts within the department within scope of knowledge.
?Maintaining microbiological isolates and performing identification, as required.
?Other duties, as assigned.
Educational and Other Requirements:
?BA or BS in Microbiology or other related science.
?Experience and Skill Requirements:
?4-7 years of Microbiology laboratory base experience in a QC testing capacity.
?Excellent microbiological skills and aseptic technique technical experience is a must.
?Thorough understanding of industry testing requirements for QC Microbiology and experience of cGMP.
?Computer literacy (MS Word and Excel), good communication and organizational skills are required. |
| | Company | | uniQure | Job Code | | State or Province | | Massachusetts | | |
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