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Amgen Inc.; Specialist Quality Assurance; New Albany, OH; Provide quality and compliance expertise and guidance on execution strategies related to the design, installation, commissioning and qualification and process qualification of the facility, equipment and information systems; Review and approve controlled documents, including Standard Operating Procedures, Validation Protocols, Validation Reports, and Electronic Master Batch Records; Provide quality oversight for quality records including deviations and Corrective and Preventative Actions (CAPAs), technical change controls and work orders assuring adherence to procedural requirements and confirming assessments and evaluations of different stakeholders are complete and accurate; Ensure that all activities and related documentation for facilities, equipment, materials and processes comply with applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and Controls; Own quality related Standard Operating Procedures, Work Instructions, Forms and Methods; Provide quality oversight for manufacturing and batch disposition; and Support and represent Quality Assurance during audits and inspections and directly interact with regulatory agencies during on-site inspections. May telecommute. Master's degree in Information Systems Technologies, Information Assurance, or related field and 3 years of experience involving the following: Ensuring products conform to established requirements and standards through audit, inspection, and test activities; Reviewing and approving validation documentation; Digital innovation, data sciences and quality engineering; Managing Root Cause Analysis and Deviation investigations; and Applying Good Manufacturing Practice (GMP) requirements in an operational setting.
Interested candidates email resume to Talent-Mobility@amgen.com. Must reference, Attn: Talent Mobility Job #20516.3379.
Job type: Full Time position. The annual salary range for this position in the U.S. is $106,463.00 -- $125,223.00 per year. Also, this position offers stock, retirement, medical, life and disability insurance and eligibility for an annual bonus or for sales roles, other incentive compensation. For more details visitÂ