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Quality Control Analyst II
Ref No.: 15-04161
Location: Allston, Massachusetts
 Quality Control Chemistry is responsible for testing intermediate and final product samples to demonstrate that all products meet all standards required for CGMP operations. Various techniques are utilized in Quality Control including, HPLC, GC, Gel Electrophoresis and multiple types of spectrophotometry. Additional functions include raw material testing, stability testing, assay transfers and the qualification of new instrumentation utilized in the Quality Control laboratory.
 
This position is responsible for performing routine and complex testing of in-process samples and final products in accordance with SOPs for product release and validation.
Responsibilities include:
 
Performing UV-Vis spectrophotometry assays for in-process and final product samples
Performing HPLC methods for final bulk material/finished goods
Performing maintenance on complex laboratory equipment including HPLC and GC systems
Review of QC Data for compliance to procedures and specifications
Calculation and evaluation of results •Participation in training of less experienced staff Transferring methods from support groups to the QC laboratory Authors protocols and technical reports related to the implementation of QC equipment
 
 
Effectively demonstrates an understanding of CGMP's and how it applies to specific responsibilities:
 
Following accurate oral and written procedures for testing of in-process and final product samples
Communicates inter-departmentally and with outside contacts to solve technical issues
Exercises sound judgment and decision making when problem solving Revises standard operating procedures as needed
Works independently under general supervision and direction
Work in compliance with CGMP's

Skills: Proficient in Outlook and Microsoft Word and Excel and lab based data management systems Ability to lift 40 lbs Exp with UV Vis Spectroscopy and wet Chemistry Scientific technical writing ability

Education: Bachelor's Degree in Life Sciences discipline and 2 years experience in CGMP lab environment
 
Or Master's Degree in Life Sciences discipline and 1 year experience in CGMP lab Environment