QC Validation Supervisor
- Employer
- AmbioPharm, Inc.
- Location
- North Augusta, SC
- Start date
- Apr 20, 2022
View more
- 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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