QC Raw Materials Analyst

Raleigh, USA

Cellectis’ Quality organization is seeking a highly motivated Quality Control– Raw Materials Analyst to complete daily QC Raw Materials activities and documentation, including but not limited to incoming materials inspection, distributing release testing samples to Bioassay and Microbiology Labs, and incoming materials testing.

Published on May 15, 2020

Responsibilities

Responsibilities include but are not limited to the following:

  • Ensure compliance with applicable US and European cGMP regulations, corporate policies and company Standard Operating Procedures
  • Perform cGMP sampling, inspections, distribution of samples, and testing on raw materials and consumables
  • Review and evaluate timely issuance, review and approval of Raw Material testing results
  • Author, review, and/or approve SOPs/policies and technical reports
  • Evaluate laboratory deviations and initiate and coordinate corrective and preventive actions as required
  • Support operational systems to track and trend key Quality Indicators and ensure KPIs are addressed
  • Execute Raw Material analytical methods as needed
  • Perform other duties as assigned by the Head of Quality or the Site Head

 

Qualifications & Experience

  • Minimum BS in a Life Science or Analytical Science, with 1-3 years of relevant laboratory experience in a biopharmaceutical company
  • Working knowledge of regulations regarding cGMP as defined by the US Food and Drug Administration and European Medicines Agency
  • Experience authoring Standard Operating Procedures and Work Instructions
  • Strong written and verbal communication skills 
  • Accountable for making independent decisions regarding daily QC Raw Materials laboratory with minimal supervision
  • Ability to set and manage priorities and schedule activities accordingly
  • Demonstrated interpersonal skills to work effectively with subordinates, peers, managers and cross-functional teams
  • Excellent organizational skills with attention to detail and deadlines