A major biotechnology company is seeking a QC Associate located in Cambridge, MA.
� Perform all task per cGMP and SOPs
� Support manufacturing by performing environmental monitoring and water sampling, also provide support during validations
� Provide support to manufacturing and purification
� Read EM plates from QC, manufacturing and bottling activities
� Submit micro identifications
� Submit Alert/Action reports through Trackwise for excursions
� Perform water testing for bioburden and endotoxon
� Enter results from QC, manufacturing, and bottling activities into LIMS
� Gain on the job training of general knowledge of industry practices, techniques, and standards
� Train lab analysts on basic assay and laboratory procedures as required
� Participate in laboratory support functions (ie. cleaning, logbook review, material stocking)
� Maintains QC Equipment for QC and Manufacturing
� Constantly update on trainings
� Assist with executing non-routine studies to support investigations
� Document work clearly, accurately, and in accordance with cGMP
� Attend team, department, and corporate meetings as required
� Demonstrate organizational skills.
� Ability to read and follow standard operating procedures.
� Ability to work under close supervision.
� Demonstrate good written and verbal communication skills.
� Ability to read and interpret technical data
� Ability to sit, stand, and move within work space for extended periods.
� Ability to perform repetitive tasks including frequent hand to finger manipulations, grasping, pushing, and pulling
� Ability to work independently and as part of a team. Interacts with employees within own department. Occasional interaction with employees from other departments.
� BS in Biological Sciences or related technical field,
� 0-2 years of related experience or equivalent combination of education and experience
Website : http://www.inventivhealth.com/