QC Associate

QC for Manufacturing - Team B Associate Quality Control

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, focusing on Oncology, Inflammation, General Medicine, and Rare Disease.

What you will do

In this vital role you will be responsible for activities including microbiology & analytical testing, sample and data management and equipment and instrumentation operation and maintenance in a highly dynamic, team environment.

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

Responsibilities

• Perform 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, including bioburden, endotoxin, TOC, conductivity, and MMV testing along with additional daily microbiological testing.
• 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.

Basic Qualifications

• High school/GED + 2 years Quality experience OR
• Associate's + 6 months Quality experience OR
• Bachelor's

Preferred Qualifications

• Professional work experience in a fast-paced, flexible GxP laboratory
• Experience in a regulated biotechnology/pharmaceutical lab environment
• Experience executing test methods for microbiology, i.e. bioburden and endotoxin testing.
• 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.

What you can expect of us

Expected annual salary range: 62,571.90 USD - 84,656.10 USD. Actual salary will vary based on relevant skills, experience, and qualifications.

In addition to base salary, Amgen offers a Total Rewards Plan, based on eligibility, that may include:

• 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, and flexible spending accounts
• A discretionary annual bonus program
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible

Application deadline

Amgen does not have an application deadline for this position; applications are accepted until a sufficient number is received or a candidate is selected.

Sponsorship

Sponsorship for this role is not guaranteed.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. Reasonable accommodations are available upon request.