• Finished Product testing, stability testing, reporting of the QC results to management
• Support laboratory investigations, deviation investigations, CAPA follow up and implementations, change control management including procedure and form revisions
• Participate in method transfer, validation/verification activities, as necessary
• Review analytical data for compliance with regulations, methods and other specifications or criteria
• Maintenance and calibration of QC Equipment
• Prepares applicable documents, forms, and records such as method forms, protocols, and work instructions following Good Document Practices
• Support internal and external Audits and Inspections, as required

• Bachelors degree in life science required.
• Experience in the following techniques: Mammalian Cell Culture, Plaque Titer, ELISA, qPCR, Southern Blot and Western Blot
• Proficient in Microsoft Word, Excel, and PowerPoint.
• Environmental monitoring experience a plus but not required.
• A demonstrated self-starter who is highly motivated and able to address changing priorities.
• Ability to take a proactive approach on the job with the ability to work with a dynamic team.
• Excellent scientific writing, other written and oral communication skills are required.

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