Quality Control Analyst I
This Quality Control Analyst II is responsible for performing routine and complex testing of in-process samples, stability
Samples and final products in accordance with SOPs for product release and validation.
· Perform UV-Vis spectrophotometry,HPLC, UPLC, and Gel assays for in-process and final product samples.
· Perform maintenance on complex laboratory equipment including HPLC, UPLC and GC systems.
· Review of QC Data for compliance to procedures and specifications.
· Calculate and evaluate results.
· Participate in training of less experienced staff.
· Transfer methods from support groups to the QC laboratory.
· Author protocols and technical reports related to the implementation of QC equipment.
· Effectively demonstrate an understanding of cGMPs and application to specific responsibilities:
· Follow accurate written procedures for testing of in-process and final product samples.
· Communicate inter-departmentally and with outside contacts to solve technical issues.
· Exercise sound judgment and decision making when problem solving.
· Revise standard operating procedures as needed.
· Work independently under general supervision and direction.
· Work in compliance with cGMPs.
· Practice safe work habits and adhere to safety procedures and guidelines.
· Experience with Dionex, GC, HPLC, Gel Electrophoresis, UV Vis Spectroscopy and wet Chemistry.
· Experience with Empower software.
· Knowledge of lab-based data management systems.
Bachelor's Degree in Life Sciences discipline and 3-6 years’ experience in cGMP lab environment, or a Master's Degree in Life Sciences discipline and 1 year experience in cGMP lab environment. Proficient in Outlook and Microsoft Word and Excel and lab based data management systems.
Laboratory Information Management Systems
Certified Global Meeting Planner
Good Manufacturing Practices
High Performance Liquid Chromatography