Primary Responsibilities:

• Quality Assurance review and approval of analytical data for release of CGMP manufacturing batches (UPLC, HPLC, IC, etc)
• Review of instrument audit trails for compliance
• Quality Assurance review and approval of analytical method protocols, validations and reports (UPLC, HPLC, IC, etc)
• Creation of CoAs for analytical testing
• Review and approval of analytical change controls and deviations and CAPAs
• Perform internal facility and quality system audits.
• Assist with SOP revisions and writing new SOPs.
• Other duties as requested by the Quality Management.

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.