Job Description: Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. As part of the Amgen’s Manufacturing Operations organization, our Amgen Woburn Manufacturing (AWM) site manufactures oncolytic virus based end-to-end drug substance and drug products for the global market. As such we continuously strive to be a leader in detailed execution to ensure we deliver our medicines to every patient, every time. Operational Excellence is at the core of how we do what we do with a continuous improvement approach, and a steadfast focus on safety, quality, and compliance. Job Responsibilities: Present the document management process during audit and inspections Represents AWM in the Amgen global Document Management Network Responsible for document archiving and retrieval during day-to-day operations and during audits and inspections Oversee access to vault storage Practices (cGMP), Good Documentation Practices (GDP) and other applicable regulations May author/review/approve documents such as standard operating procedures Supports AWM by providing coaching, guidance and direction regarding document management Monitors performance of the document management system and prepares inputs and recommendations for site Management Review Responsible for providing document management oversight to ensure that document management process is executed according to standards Job Requirements: Experience representing Amgen while interacting with representatives of regulatory agencies Scientific degree in Life Sciences, Physical Sciences, Applied Engineering or Manufacturing Technologies Previous document management system oversight Ability to evaluate compliance issues and interact with regulatory inspectors Ability to solve complex problems and make scientific risk-based decisions Demonstrated proficiency of written and verbal communication skills (including technical writing and presentations) with ability to communicate and collaborate effectively with technical and senior management staff. Experience of trending analysis Demonstrated proficiency using Excel, Word and Power Point Experience and training in CDOCS, Infolinx Experience in handling multiple, competing priorities in a fast-paced environment Qualification & Experience: Bachelor’s degree and 2 years of Quality or Operations experience High school diploma / GED and 8 years of Quality or Operations experience Master’s degree Associate’s degree and 6 years of Quality or Operations experience Job Details: Company: Amgen Vacancy Type: Full Time Job Functions: General Business Job Location: Woburn, MA, US Application Deadline: N/A Apply Here yours-vacancy.net
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