Quality Control Associate I - QC for Manufacturing Team B

at  Amgen

BASIC QUALIFICATIONS:

• Bachelor’s degree OR
• Associate’s degree and 4 years of Quality experience OR
• High school diploma / GED and 6 years of Quality experience

PREFERRED QUALIFICATIONS:

• Professional work experience in a fast-paced, flexible GxP laboratory
• Experience executing test methods for microbiology and raw materials.
• Experience with gowning and sampling within clean room areas.
• Operation, maintenance experience with laboratory equipment.
• Demonstrated proficiency with electronic systems (LIMS, LMES, Trackwise, etc.).
• Exposure to Operational Excellence initiatives including Lean Manufacturing and 5S.
• Demonstrated written and oral communication skills, project management and presentation skills, and proven ability to manage priorities effectively.
• Demonstrated ability to be flexible and adaptable to support business needs.

Let’s do this. Let’s change the world. In this vital role under minimal supervision, as the Quality Control Associate you will be responsible for activities including microbiology & analytical testing, sample and data management, as well as equipment and instrumentation operation and maintenance in a highly dynamic, team environment.

• Perform on site sample collection and sample handling to support GMP operations and Environmental/Water monitoring within Manufacturing and Utility areas.
• Perform testing and possible data review for compendia, non-compendia methods, and routine laboratory procedures.
• Daily review and authorization of environmental and in process batches.
• Use of testing and data review within automated sampling systems, such as LIMS, LMES, and CIMS.
• Generate complete, accurate, and concise laboratory documentation using electronic systems and laboratory notebooks.
• Operate and maintain specialized laboratory equipment and instrumentation.
• Participate in laboratory investigations and audits as necessary.
• Perform general laboratory housekeeping activities.
• Maintain training compliance and proficiency.
• At all times, comply with safety guidelines, cGMPs and other applicable regulatory requirements.