Job Description: 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. Under general supervision, this position will perform routine procedures and testing in support of the Quality Control (QC) Microbiology Environmental Monitoring (EM) Lab. Job Responsibilities: Maintaining and operating specialized equipment Assisting the Laboratory Manager with daily management of the QC Microbiology Lab, including scheduling of daily activities, troubleshooting issues and ensuring adherence to sample due dates Learn and comply with safety guidelines and Good Manufacturing Practices (cGMPs) / Code of Federal Regulations (CFRs) which includes, but is not limited to, the maintenance of training records, laboratory documentation, written procedures, building monitoring systems and laboratory logbooks Performing Personnel Monitoring for gowning certifications Quality systems support, which may include ownership of Nonconformances, Analytical Result Assessments and Change Control records Development, implementation, coordination and maintenance of laboratory improvements Performing Environmental Monitoring in the Manufacturing plants Initiating and / or implementing changes in controlled documents Documenting, computing, compiling, interpreting and entering data Qualification & Experience: Previous experience in a regulated GMP environment Experience in the following areas: QC Microbiology methods, Environmental Monitoring, Endotoxin testing, Growth Promotion testing, Water sampling, Bioburden testing and Result Reporting Operation, maintenance, and troubleshooting experience with Environmental Monitoring equipment and instrumentation Experience with Cleanroom gowning Experience and training in aseptic technique Experience using Laboratory Information Management System (LIMS) Experience and knowledge of Data Integrity Requirements of Quality Control Systems Master’s degree Associate’s degree and 6 years of Quality Control experience High school diploma / GED and 8 years of Quality Control experience Job Details: Company: Amgen Vacancy Type: Full Time Job Location: Boston, MA, US Application Deadline: N/A Apply Here vacancyoptions.com
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