QC Analyst- (Quality- OTC Lab)

• 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
• 401k match