uniQure

QC Analytical - Temp and/or Perm. - Lexington, MA

All jobs Print Apply
English

Job

Active since 25-05-2017 Job category Quality / Health / Environment ...
Location Lexington, MA Level Professional
Educational level Bachelor / Graduate Employment type -
Hours 40 Salary Competitive
The QC Analyst Contractor will be responsible for routine/nonroutine QC sampling and testing according to Standard Operating Procedures (SOPs). This position will be based at uniQure’s state of the art facility in Lexington, MA.

Key Responsibilities:

  • Perform routine/non-routine testing of in-process, final product, raw material samples in accordance with Standard Operating Procedures such as Protein Assays (Bradford, Lowry), Q-PCR, Potency Assay, Western Blot, Refractometry, Osmolality, ELISA, etc.
  • 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.
  • Participate in equipment validation, method validation, and special protocol.
  • Establish, revise, review and maintain procedures (including protocol and technical report).
  • Assist in the management of the lab and assay transfer/set up from Amsterdam.
  • 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.
  • Water testing (such as heavy metals, nitrates, pH, conductivity, and TOC, etc.).
  • Aseptic technique and working with cell culture and live viruses.
  • Responsible for protocol and report generation, as required.
  • Perform sample management such as receipt, inventory, tracking, and aliquoting.

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 5 years of QC Analytical laboratory experience 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 Pharmaceutical
Region United States
Keywords Quality Control, Analyst

Contact information

Name Jennifer Wagner

Location

Apply