Quality Control Associate

BioSpace; West Greenwich (RI); On-site; USD 60,000 - 90,000; Full time

Job summary

Amgen is seeking an Associate Quality Control specialist in Rhode Island to perform microbiology and analytical testing, manage samples and data, and operate lab instrumentation in a dynamic team setting.

The role requires strong GxP experience, effective communication, and the ability to generate precise documentation while maintaining strict compliance with safety and regulatory standards. Expect a 10-hour shift schedule and ongoing professional development.

Qualifications

• Experience in a regulated biotechnology/pharmaceutical lab environment.
• Written and oral communication skills for quality/compliance documents.
• Flexibility to support business needs and projects.

Responsibilities

• Perform analytical testing, characterization, sample and data management.
• Collect and handle samples to support GMP operations.
• Test and review data for compendial and non-compendial methods.
• Generate complete, accurate laboratory documentation using electronic systems.
• Operate and maintain specialized laboratory equipment and instrumentation.
• Participate in investigations and audits as necessary.
• Maintain safety guidelines, cGMPs and regulatory compliance.
• Maintain training compliance and proficiency.

Skills

Microbiology testing

GxP experience

Communication skills

Electronic systems (LIMS/Trackwise)

Project management

Lean Manufacturing / 5S

Education

High school/GED + 2 years experience

Associates + 6 months experience

Bachelor's degree

Tools

LIMS

LMES

TrackWise

Job description

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Join Amgens Mission of Serving Patients

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds 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, youll 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.

Associate Quality Control

What You Will Do

Lets do this. Lets 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

• Responsible for one or more of the following activities in Quality Control including 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

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 [Job Codes Discipline and/or Sub-Discipline] work experience OR
• Associates + 6 months [Job Codes Discipline and/or Sub-Discipline] work experience OR
• Bachelors

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 (ie. 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

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, well 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.