Quality Control Associate

About the role

At Amgen, our shared mission to serve patients living with serious illnesses drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. In this vital role, you will be responsible for activities including microbiology and analytical testing, sample and data management, and equipment and instrumentation operation and maintenance in a highly dynamic, team environment.

This role is expected to work a 10-hour shift Saturday - Tuesday, from 6:45AM-5:15PM.

Responsibilities

• Responsible for one or more of the following activities in Quality Control: analytical testing, characterization, sample and data management
• Perform sample collection and sample handling to support GMP operations
• Perform testing and possible data review for compendia, non-compendia methods, and routine laboratory procedures
• 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

Requirements

We are all different, yet we all use our unique contributions to serve patients. The dedicated professional we seek is a good teammate with these qualifications.

Basic Qualifications

• High school/GED + 2 years [Job Codes Discipline and/or Sub-Discipline] work experience
• Associate’s degree + 6 months [Job Codes Discipline and/or Sub-Discipline] work experience
• Bachelor’s degree

Preferred Qualifications

• Experience in a regulated biotechnology/pharmaceutical lab environment
• Professional work experience in a fast-paced, flexible GxP Microbiology Laboratory
• Experience executing microbiological test methods (e.g., Endotoxin, PCR, Growth Promotion Testing)
• Experience supporting Environmental and Clean Utility monitoring programs
• Demonstrated written and oral communication skills with ability to write effective science-based quality and compliance documents
• Demonstrated ability to be flexible and adaptable to support business needs
• Experience executing endotoxin, media qualification, and sterility testing
• Demonstrated proficiency with electronic systems (LIMS, LMES, Trackwise, etc.)
• Exposure to Operational Excellence initiatives including Lean Manufacturing and 5S
• Demonstrated project management and presentation skills, and proven ability to manage priorities effectively

Benefits

From our competitive benefits to our collaborative culture, we support your journey every step of the way.

• A comprehensive employee benefits package, including:
  • A Retirement and Savings Plan with generous company contributions
  • Group medical, dental, and vision coverage
  • Life and disability insurance
  • Flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible

Pay

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

Schedule

10-hour shift: Saturday - Tuesday, 6:45 AM - 5:15 PM.