Sr Quality Assurance Specialist

Millipore Corporation

2020-10-12 20:19:40

Job location Carlsbad, California, United States

Job type: fulltime

Job industry: Other

Job description

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
  • Complete line clearances
  • General product observation
  • Reviewing process validation documentation
  • Logging and monitoring quality related data
  • Other Quality Assurance related duties and projects as assigned

Physical Attributes:

  • Sitting and reaching to use computers and other office equipment
  • Viewing objects at close and distant ranges
  • Employee works in a professional office environment with computer equipment and at times within a manufacturing and laboratory environment with machinery, tools, and moderate amounts of noise and activity
  • Employee may occasionally be exposed to fumes, airborne particles, chemicals, vibration and biohazardous materials

Who you are:
Minimum Qualifications:

  • High School Diploma or GED equivalent and 3+ years of experience in Biologics, 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
  • 2+ years of experience supporting client audits and regulatory inspections

Preferred Qualifications:

  • Bachelor's degree in a scientific discipline
  • 2+ years of Contract Manufactured Organization (CMO) experience
  • 2+ years of experience identifying, communicating, investigating, and driving quality system events to completion
  • Knowledge of governmental regulatory guidelines, directives, and regulations relating to the manufacture of biologics and pharmaceuticals
  • Cleanroom experience
  • Experience performing internal audits


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