Amgen Jobs – Senior Associate

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

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