QC Analyst I/II - Analytical - Lexington, MA

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Active since 21-03-2018 Job category Quality / Health / Environment ...
Location Lexington, MA Level Professional
Educational level Bachelor / Graduate Employment type -
Hours 40 Salary Competitive

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.

Main purpose of the job:

The QC Analyst will be responsible for routine/non-routine QC sampling and testing according to Standard Operating Procedures (SOPs). This position is based at uniQure’s new state of the art facility in Lexington, MA.

Key Responsibilities:

  • Assist with the new lab set up and system maintenance.
  • Participate in equipment validation, method transfer/validation, and special protocol.
  • Establish, revise, review and maintain procedures (including protocol and technical report).
  • Responsible for change control and deviation related to QC operations, including assisting with LIs, OOSs, and OOTs.
  • Oversee sampling and storage of QC samples and maintain retain inventory.
  • Maintenance of laboratory equipment/instrument and systems to ensure compliance.
  • Perform routine/non-routine testing of in-process, final product, raw material samples in accordance with Standard Operating Procedures (Protein Assays (Bradford, Lowry), Q-PCR, Potency Assay, Western Blot, Refractometry, Osmolality, ELISA, etc.)
  • Water testing (such as heavy metals, nitrates, pH, conductivity, and TOC, etc.).
  • Responsible for protocol and report generation/revision, as required.
  • Perform sample management such as receipt, inventory, tracking, and aliquoting.
  • Coordinate shipment of samples to contract testing laboratories, as required.
  • Assist with data trending and aid in compilation of trend reports.
  • Complete documentation in accordance with current Good Manufacturing Practices (cGMP).
  • Maintain QC lab and related systems to ensure compliance with industry standards.

Other Responsibilities:

  • Troubleshoot equipment and analytical testing methods.
  • Manage technical studies performed with external companies with provision and review of reports.
  • Maintain QC Laboratory related systems in compliance with industry standards.
  • Training of other QC Analysts within the department.
  • Other tasks, as assigned.

Educational Requirements:

  • BA or BS in Chemistry/Biochemistry or other related science.

Experience and Skill Requirements:

  • Minimum 3years of analytical laboratory base experience within QC testing capacity, preferably in GLP/cGMP environment.
  • Excellent analytical and relevant instrumentation skills such as Q-PCR, Osmometer, Refractometer, HPLC, and Gel Electrophoresis, etc.
  • Thorough understanding of industry testing requirements/standards.
  • Computer literacy (MS Word, Excel, and LIMS).
  • Good/effective communication and organizational skills with the ability to work well with others and independently.
More information
This listing is a full-time job

Job category Quality / Health / Environment / Safety
Industry / Industries Biotechnology
Region United States
Keywords Quality Control, Analytical

Contact information

Name Jennifer Wagner