QC Associate

Amgen Inc. (IR); West Greenwich (RI); On-site; USD 63,000 - 85,000; Full time

Benefits offered by this job

Competitive benefits

Annual bonus program

Stock-based incentives

Flexible work models

Job summary

Amgen is seeking a QC for Manufacturing - Team B Associate Quality Control to perform microbiology and analytical testing, sample and data management, and instrumentation operation in a dynamic GMP environment. This role follows a 10-hour shift Saturday to Tuesday, 6:45 AM to 5:15 PM.

You will work with LIMS, LMES, and Trackwise, generate accurate documentation, maintain training, and ensure safety and cGMP compliance while supporting manufacturing and utility areas.

Qualifications

• Experience in a regulated biotech/pharma lab environment.
• Experience executing test methods for microbiology (bioburden, endotoxin).
• Ability to work in GMP and cGMP environments with proper documentation.

Responsibilities

• Perform sample collection and handling to support GMP operations and environmental monitoring.
• Conduct testing and data review for compendia/non-compendia methods and routine lab procedures.
• Operate and maintain laboratory equipment and instrumentation.
• Generate complete, accurate laboratory documentation using electronic systems and notebooks.
• Participate in investigations, audits, and general housekeeping.
• Maintain training compliance and ensure safety and regulatory guidelines.

Skills

Quality experience

GxP laboratory experience

Regulated biotech/pharma lab

Microbiology testing

Gowning in clean room

Electronic systems

Lean Manufacturing / 5S

Communication skills

Education

High school diploma or GED

Associate’s degree

Bachelor’s degree

Tools

LIMS

LMES

Trackwise

Job description

Career Category Operations 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 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 include:

• 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 dedicated professional we seek is a good teammate with these qualifications.

Basic Qualifications:

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

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.

Benefits

• 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.

Salary Range 62,571.90USD -84,656.10 USD

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.

Equal Opportunity

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.

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen