Address
Form of work- 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
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
