Sr QA Specialist -- Cell and Gene Therapy

Location
El Camino Real in Carlsbad
Posted
Jul 02, 2021
Required Education
Bachelors Degree
Position Type
Full time

Your Role

As a member of the Client Facing Quality Assurance team, you will be responsible for the critical, quality review and disposition of raw materials and product batch records. In this role you will effectively communicate with clients, independently manage timelines, and continually strengthen client relations. You will also work independently within prescribed guidelines and collaboratively as part of a team as well as be able to obtain direction and commitment to ensure that projects are completed by deadlines and streamlining processes to maximize productivity. This role will work successfully, strategically and tactically in a fast-paced, multi-disciplinary environment with potential for rapidly changing priorities. This position has the utmost responsibility for compliance with the rules and regulations regarding a safe and healthy work environment relative to their actions. Off-shift, weekend, and overtime duties may be assigned by the manager of the employee.

  • Performing product inspections and facility inspections
  • Batch Record reviews
  • Deviation and Change Management
  • Reviewing process validation documentation
  • Logging and monitoring quality related data
  • Other Quality Assurance related duties and projects as assigned

  

Who You Are:

Minimum Qualifications:

  • Bachelor’s Degree in Biology, Chemistry or other Scientific discipline
  • 3+ years of experience in Biologics, Biotech, Pharmaceuticals or Medical Devices.
  • 3+ years of experience working within Quality in a cGMP environment
  • 2+ years of experience creating, revising, reviewing, and approving of controlled documentation
  • 1+ years of experience supporting client audits and regulatory inspections

Preferred Qualifications:

  • Contract Manufactured Organization (CMO) experience
  • Batch record review
  • Knowledge of governmental regulatory guidelines and regulations relating to the manufacturing of biologics and pharmaceuticals
  • Manufacturing or Cleanroom experience
  • Experience performing internal audits