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Equipment Qualification Administrator
Ref No.: 18-10596
Location: Devens, Massachusetts
Job Description: Equipment Qualification Administrator needed for the Quality Control Technical Support team in Devens, MA to participate in analytical instrument qualification such as Chromatography systems, Immuno assay equipment, TOC, FTIR, SpectraMax L, AKTA, and Karl Fisher. Administration activities including entering work flows into Maximo, supporting SOP drafting and drafting of Protocols/Reports related to Lifecycle Management of above mentioned instrumentation.

Major Duties and Responsibilities:
• Participate in analytical instrument qualification by developing User Requirement and Risk Assessment documentation and drafts of IQ/OQ/PQ Protocols/Reports for Lifecycle Management of instrumentation.
• Review and communication of instrument qualification in a concise, organized, and compliant manner.
• Author SOPs and training documents.
• Knowledge of science generally attained through studies resulting in a BS/MS Degree or equivalent preferably in Biological Sciences.
• A minimum of 3 years relative experience in scientific QC methodologies, Biologics QC laboratory, or related biopharmaceutical cGLP or cGMP lab.
• Expertise in operational knowledge of analytical instruments and instrument qualifications.
• Knowledge of applicable business systems including: Trackwise, Maximo, MS Project.
• Strong interpersonal, oral and written communication skills.
• Ability to prioritize objectives from multiple projects, adhere to scheduled timelines while maintaining flexibility and attention to detail.
• Contribute to a team based, collaborative, and positive environment, with clarity of purpose and a high commitment to business goals.
Additional Job Requirements: