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QC Validation Supervisor

Employer
AmbioPharm, Inc.
Location
North Augusta, SC
Start date
Apr 20, 2022

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Discipline
Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Full time
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  • Basic understanding and knowledge of instrumentation, lab functions, and techniques to identify problems and trouble shoot problems to the completion of work assignments.
  • Become familiar with, and adhere to, requirements as documented in SOPs for Good Manufacturing Practices.
  • Prepare and review Protocol, Reports, Development report, Change controls as well as quality control Specification & test methods.
  • Supervise daily activities of their group chemists and leads.
  • Support method optimization, transfer, and validation activities.
  • Support routine R & D support analysis of quality control testing for drug substances and drug product by using GC, HPLC, IC, GCMS, and UHPLC.
  • Support QA for DP stability data tracking and trending.
  • Oversee minimum of 4-6 peers for regular validation/ transfer and verification testing.
  • Assist the QC group with writing and editing of deviations, CAPA, OOS and OOT.
  • Develop teamwork and communication skills through active listening and honest dialog with peers and supervisors.
  • Communicate effectively with internal team personnel, as well as external team.
  • Track all the sales order for method validation/Verification and transfer work on timely manner.
  • Other duties as assigned by management.

Qualifications:

  • Minimum Education: Bachelor or Master degree in Chemistry, life sciences, or related discipline.
  • Minimum Laboratory Experience: 5-7 years for Bachelor degree and 4-6 years for Master degree of bench experience in an Quality control laboratory environment.
  • Must be able to push, pull, squat, stand and walk through-out the day
  • Must be able to lift up to 40lbs.
  • Proficiency in use of software including Microsoft Word and Microsoft Excel.
    Good communication and writing skills.
  • Empower 2 or 3 software proficiency is preferred.
  • 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.
  • Must be able to work in a chemical environment

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