Integrated Resources, Inc

Company Details

Quality Control Analyst

Job ID

: 22788

Location

: Cambridge, MA, USA

Salary

: Not Specified

Job Views

: 32

Posted

: 10-14-2019

Key Skills

"CELL CULTURE" OR BIOASSAY OR ELISA OR QPCR

Job Description

Quality Control Analyst – QC Testing Group (Contract)
Duration: 12 months

Location: Cambridge, MA

Join bluebird bio’s enthusiastic and collaborative team by contributing to the overall success of our novel gene therapy approach. We seek a QC Analyst to support establishing new commercial-level GMP testing laboratories for release and stability for multiple stages of our gene therapy products.   This includes performing analytical methods, data review and trending, supporting continuous improvement of GMP systems to ensure a compliant Quality Control lab. The candidate will interface with Analytical Development and Method Validation ensuring successful method transfer, Quality Assurance, IT, Facilities, and other cross-functional teams as required.  A cGMP operational and technical background in cell biology, biochemistry, and/or molecular biology will be utilized in the role.

About the Role:

  • Perform cGMP analytical testing (pH, osmolality, appearance, bioassay, cell culture, flow cytometry, qPCR, and ELISA)
  • Review and evaluate raw data (peer review level)
  • Author SOPs/Forms and technical reports with guidance
  • Initiate laboratory deviations and support investigations (IA, OOS, AR), performing assessment, authoring protocols/reports and investigation closure with guidance
  • Author, review, and execute equipment validations with guidance
  • Support operational systems (equipment/instrument maintenance/calibration, equipment alarm monitoring, sample handling/tracking, data integrity/control, cGMP documentation, LIMS, laboratory audit, and method training)
  • Execute phase-appropriate test method validation protocols as needed
  • Participate in providing the necessary information for regulatory filings and inspections.
  • Support CAPA/Continuous Improvement Initiatives

About You:

  • BS with 4+ years in a biotechnology discipline
  • 4+ years of experience in a cGMP/GxP environment is preferred
  • Preferable hands on experience in cell culture, flow cytometry, quantitative PCR, and other bioanalytical methods such as ELISA
  • Superb organizational, analytical, and communications skills and “do-what-it-takes” attitude
  • A passion for addressing the critical unmet medical needs of patients
  • Self-directed individual who is able to work with limited direction in a fast-paced, goal-oriented environment

Willingness to embrace and demonstrate the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself

 

 

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Employment Types
Contract - W2
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