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QA Lab Operations Specialist
Ref No.: 18-17390
Location: Devens, Massachusetts
Job Description: Job Title: QA Lab Operations Specialist

Equipment Qualification Administrator needed for the Quality Assurance Lab Operations team in Devens, MA to participate in analytical instrument qualification such as Chromatography systems, Immunoassay instruments, Bioassay instruments, and Molecular Biology instruments. Administration activities include review and/or approval work flows for Maximo, SOP, Protocols/Reports, and any associated exceptions related to Lifecycle Management of above mentioned instrumentation.

Major Duties and Responsibilities:
• Participate in analytical instrument qualification through Pre-approval of IQ/OQ vendor documentation, as well as reviewing/approving documentation associated with Lifecycle Management of instrumentation (User Requirement and Risk Assessment documentation, Protocols/Reports, vendor documentation, forms, and SOP.
• Provide QA approval of all exceptions related to the IQ/OQ/supplemental Test script execution of instrument qualification activities.
• Knowledge of science generally attained through studies resulting in a BS/MS Degree or equivalent preferably in Biological Sciences.
• A minimum of 4 years relative experience in Quality Assurance.
• Demonstrated expertise in operational knowledge of analytical instruments and instrument qualifications.
• Working knowledge of applicable business systems including: Trackwise, Maximo, DCA, LIMS, and electronic notebooks (Smartlab/LES) is a plus.
• Strong interpersonal, oral, and written communication skills.
• Ability to adhere to scheduled timelines while maintaining flexibility and attention to Quality.
• Contribute to a team based, collaborative, and positive environment, with clarity of purpose and a high commitment to business goals.
Additional Job Requirements: