Job description – QC Analyst II – Flow Cytometry

Cognate is currently seeking an Analyst II to perform flow cytometry for our Quality Control Department. The successful candidate will be responsible for performing routine quality control product and raw material release testing utilizing multi-color flow cytometry as well as various biochemistry, molecular biology, and general laboratory techniques according to GMP. Additionally, the analyst will assist with technology transfer of new client assays by authoring SOPs or other required documentation and/or assisting QC Scientists.

The position requires the utmost attention to detail, very strong organizational skills, computer proficiency, and a basic understanding of laboratory instrumentation. In addition, effective communication skills and the ability to function in a fast-paced, highly technical environment with minimal supervision are essential for success.
 

DUTIES AND RESPONSIBILITIES:

  • Perform routine in-process and final release assessments of products using multicolor flow cytometry
  • Reviews test results of other QC analysts for accuracy and precision and maintains efficient workflow of all required testing documentation ensuring timely submission relative to product release dates
  • Enters assay results into the appropriate trending databases for periodic analysis
  • Assists the QC Team with maintaining proper overall operation of department (physical inventories, logs, documentation, filing, etc.)
  • Maintains familiarity with QC-relevant cGMP guidances (CFR, USP, EP, ICH, etc.)
  • Drafts new SOPs or other documentation, as required, in support of new procedures adopted by the QC Department, either internally or at client request
  • Assists with the implementation of quality improvement initiatives for QC laboratory operations
  • Participates in laboratory, OOS, CAPA or other investigations, as required
  • Maintains laboratory supplies, media and reagents inventory
  • Adheres to standard operating procedures and good documentation practices to ensure data integrity and traceability
  • Responsible for assisting with routine laboratory upkeep and organization
  • Other duties as required

 

EDUCATION AND/OR WORK EXPERIENCE REQUIREMENTS:

  • Previous experience running multi-color flow cytometry on blood-derived cell types
  • Familiarity with FACS Canto II flow cytometer or similar preferred.
  • BS or higher degree in the biological sciences or related field with a minimum of 4 years relevant laboratory experience or experience in a cGMP/FDA regulated industry
  • Ability to work independently and as part of a team
  • Demonstrated knowledge in “core” laboratory techniques (e.g. ELISA, cell culture/counting, PCR, etc.) and aseptic techniques required
  • Detail-oriented with strong written and verbal communication skills
  • Ability to problem-solve and troubleshoot as necessary

 

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