QA Associate I
Job Details
Corporate Headquarters - North Augusta, SC
Full Time
4 Year Degree

Quality Assurance Associate I

Primary Responsibilities:

  • Review and release of raw materials. Ensuring that all materials are reviewed and released within the required time frame. Request deviations are needed.
  • Track and disposition materials past re-evaluation dates.
  • Review and track all temperature chart recorders. Request deviations as needed.
  • Review and disposition cleaning verification batch records and testing packages.
  • Perform room and equipment clearances per procedure following cleaning conducted by production.
  • Maintain a full understanding of all AmbioPharm SOPs and policies along with all cGMP, CFR, ICH guidances that are applicable to the manufacturing of APIs.
  • Issues re-packaging paperwork and performs review and approval when returned. Tracks the documentation through the process.
  • Issues labels as requested.
  • Perform weekly housekeeping tours.
  • Works cross-functionally to assess impact for potential deviations and assist in identifying if an investigation is required.
  • Other assignments as needed within the scope of QA Associate training curriculum. These assignments may be distributed among the QA I Associates.
  • Enforcement of GMP Compliance.
  • Promotes teamwork and good communication.

QUALIFICATIONS:

  • A Bachelors Science Degree is required.  (Chemistry, Biology, or other Life Science degree) or one-year work experience in manufacturing / laboratory at AmbioPharm.  (Exceptions can be made if the candidate is an employee of Ambiopharm).
  • Microsoft Office Suite proficiency is required; this includes Microsoft Office.
  • Team player with good communication skills, proficient reading, and comprehension skills.
  • Familiarity with basic laboratory instrumentation
  • Safe work habits
  • Ability to follow written and verbal instructions and make sound decisions when needed.
  • Able to work with limited supervision for routine tasks.
  • ADA-These Requirements are a Condition of Employment:

  • Must be able to push, pull, squat, stand, sit and walk through-out the day.
  • Must be able to lift to 20lbs.
  • Must be able to wear safety shoes & glasses through-out the day while in designated areas. (provided by the company)
  • You must be cleared by a physician to wear a respirator throughout the day while in designated areas.
  • You must be able to work in a chemical environment.
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