Diposting di: Lain-lain di Amerika Serikat | Terkirim: |
Review daily instrument calibration and verifications; and review of logbooks
Review testing with other analysts and supervisor
Perform calibration and system suitability using approved Methods
Problem solve with colleagues regarding OOS results, discuss additional testing, operation of equipment, meeting to share ideas. CAPA responsibility
Review NCRs prior to submission to Lab Manager, check calculations, possible cause with review of batch records.
Assist with quality and environmental health and safety audits
Perform analytical testing using HPLC, GC, ICP-OES, UV-VIS, Karl Fischer, etc.
Compliance to Data Integrity requirements
Assist with investigation of quality issues such Out of Specification (OOS), Out of Trends (OOT), etc.
Train on and support the chemical hygiene program for the laboratory
Execute testing methods, protocols and other work instructions
Assist in managing of chemical and consumable stocks
Perform calibrations and system suitability under supervision
Familiar with USP/NF Compendia, ASTM, ISO Stds
Familiarity with US FDA 21CFR Part 210 & 211 (Drug Product) and Cosmetic GMPs is mandatory
Requirements
Bachelor’s degree in Chemistry or related field
Strong knowledge in GMP, GLP, Root Cause Analysis & Corrective Action Planning Tools
Laboratory management experience preferred, with experience in Cosmetic or Pharmaceuticals desired
1+ years Quality Control Analytical Lab experience with HPLC, GC, ICP-OES, UV-VIS, Karl Fischer, etc
Good interpersonal and written communication
Flexible, ability to multitask and designate
Good organizational skills
Benefits
Medical, Dental, and Vision Insurance
Life Insurance paid 100% by the company
401K after 6 months