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.