Senior Quality Assurance Associate

4 days ago


Thousand Oaks, United States Randstad Life Sciences US Full time

Senior Associate Quality Assurance

3 Years

Thousand Oaks, CA

Max PR: $37.44/hr


HIRING NOTES:

Must be flexible as it is possible worker will start on any shift. Rotate every 6 months.

  • DAY 7 AM - 8 PM
  • SWING 1 PM to Midnight
  • NIGHT SHIFT 7 PM - 8 AM
  • Will change on the business they are supporting
  • Rotate every 6 months


Basic Qualifications

  • Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience

Top 3 Must Have Skill Sets:

  • - Flexibility on shifts
  • - Attention to detail
  • - Quality background

Day to Day Responsibilities:

  • Duties include purposeful presence on the floor, electronic batch record review, SOP revision & approval, work order approval, and quality approval of minor deviations . Responsibilities will include evaluation of compliance issues, providing recommendations, and assuring progress of quality records to completion. The Sr. Associate will also represent functional area for the Drug Substance Quality Assurance department in the execution of projects necessary to achieve departmental operational goals and will work in a team matrix environment.



Job Summary

This position supports Company’s Quality Assurance program under the Plant QA organization providing daily oversight of the Drug Substance manufacturing areas. Under general supervision, the role provides support and compliance oversight to Manufacturing and Facilities & Engineering areas/staff in the execution of their processes, procedures, and use of quality systems.


Job Responsibilities

Duties include purposeful presence on the floor, electronic batch record review, SOP revision & approval, work order approval, and quality approval of minor deviations . Responsibilities will include evaluation of compliance issues, providing recommendations, and assuring progress of quality records to completion. The Sr. Associate will also represent functional area for the Drug Substance Quality Assurance department in the execution of projects necessary to achieve departmental operational goals and will work in a team matrix environment.


Education & Qualifications

  • Bachelor's Degree in Biochemistry, Biology, Chemistry, or related science field.
  • Demonstrated ability to perform GMP operations including following detailed SOPS, maintaining training, and good documentation practices.
  • Also, ability to make Quality based decisions in order to ensure compliance.
  • Experience managing projects through to completion & meeting timelines.
  • Evaluating documentation and operations according to company procedures.
  • Experience working with Quality Systems, Strong organizational skills and ability to manage multiple tasks at one time/ Effective communication skills (both written and verbal)
  • Demonstrated ability to work as both a team player and independently
  • Display leadership attributes and drive improvement initiatives.



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