QC for Manufacturing - Team B Associate Quality Control

Amgen; West Greenwich (RI); On-site; USD 70,000 - 100,000; Full time

Benefits offered by this job

Retirement plan

Discretionary bonus program

Stock-based incentives

Time-off plans

Flexible work model

Job summary

Amgen is seeking a QC for Manufacturing - Team B Associate Quality Control to perform microbiology testing and data management within a fast-paced GMP environment. You will handle sample collection, testing, documentation, and instrument operation while maintaining cGMP compliance.

The role requires a Bachelor’s degree or equivalent experience, with preferred background in GxP labs and experience with LIMS/Trackwise; strong attention to detail and teamwork are essential.

Qualifications

• Bachelor’s degree required OR Associate’s degree with 6 months quality experience OR High school/GED with 2 years quality experience.
• Experience in fast-paced GxP laboratory environments preferred.
• Experience executing test methods for microbiology (bioburden, endotoxin) preferred.

Responsibilities

• Perform sample collection and handling to support GMP operations and Environmental/Water monitoring.
• Perform testing and data review for microbiology and routine laboratory procedures.
• Operate and maintain laboratory equipment and instrumentation.
• Generate accurate laboratory documentation using electronic systems and notebooks.
• Maintain training compliance and ensure safety and regulatory guidelines are followed.

Skills

Quality control

GxP

Microbiology

LIMS

LMES

Trackwise

cGMPs

Regulatory compliance

Education

Bachelor's degree

Associate's degree

High school/GED

Tools

LIMS

LMES

CIMS

Trackwise

Job description

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. 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. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

QC for Manufacturing - Team B Associate Quality Control

What You Will Do

Let’s do this. Let’s change the world. In this vital role 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 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. This includes 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.

What We Expect Of You

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

Basic Qualifications

• Bachelor’s
• OR
• Associate’s + 6 months quality experience
• OR
• High school/GED + 2 years quality experience

Preferred Qualifications

• Professional work experience in a fast-paced, flexible GxP laboratory
• 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

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

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.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities 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, 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. Refer to the Work Location Type in the job posting to see if this applies.

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Sponsorship

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

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.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.