Associate Quality Control

Amgen SA; West Greenwich, Northern (RI, KY); Hybrid; USD 65,000 - 95,000; Full time

Benefits offered by this job

Retirement plan

Medical, dental, and vision coverage

Life and disability insurance

Flexible spending accounts

Discretionary annual bonus

Stock-based incentives

Generous time-off plans

Flexible work models where possible

Job summary

Amgen is seeking an Associate Quality Control for day shifts to perform routine microbiology testing and document data in a cGMP environment.

You will handle bioburden, endotoxin, sterility testing and contribute to deviations and TRAs in the quality system, with focus on QA documentation and compliance.

Qualifications

• Detail oriented and meticulous in documentation and data review.
• Experience in a fast-paced GxP laboratory setting.
• Ability to perform routine laboratory procedures and data entry in cGMP environments.

Responsibilities

• Perform routine microbiology testing including bioburden, endotoxin, and sterility methods.
• Maintain and review laboratory documentation and records in electronic systems.
• Operate and maintain laboratory equipment and assist with investigations and audits.

Skills

Detail oriented

GxP laboratory experience

Quality documentation

Education

Bachelor's degree

Associate degree

High school diploma / GED

Tools

LIMS

LMES

CIMS

CDOCS

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.

Associate Quality Control - Days

What you will do

Let’s do this. Let’s change the world. In this vital role you will perform routine procedures and testing in support of the Microbiology, Endotoxin Testing, PCR, TOC, Conductivity Testing group. This position will be responsible for one or more of the following activities: - Performing routine laboratory procedures - Routine analytical testing - Documenting, computing, compiling, interpreting and entering data - Maintaining and operating specialized equipment - Initiating and / or implementing changes in controlled documents. Must learn and comply with safety guidelines and cGMPs/CFRs which includes, but is not limited to, the maintenance of training records, laboratory documentation, written procedures, building monitoring systems and laboratory logbooks. Shift: Monday - Friday 7am - 3:30pm

Responsibilities include:

• Perform testing and data review for compendia, non-compendia methods, and routine laboratory procedures. This includes bioburden, endotoxin, sterility, growth promotion, and microbial ID testing along with additional microbiological testing.
• Perform bioburden, endotoxin, and sterility validation testing for product, raw materials, and component sample types.
• Initiate deviations and TRAs for quality events in DQMS
• Draft and review documents in CDOCS, as needed.
• Perform gowning monitoring certification sampling in the manufacturing grade 5 environment
• 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 detail oriented with these qualifications.

Basic Qualifications:

• High school diploma / GED and 2 years of Quality experience OR
• Associate’s degree and 6 months of Quality experience OR
• Bachelor’s degree

Preferred Qualifications:

• Professional work experience in a fast-paced, flexible GxP laboratory
• Experience executing microbial test methods (i.e. bioburden, endotoxin, microbial identification, growth promotion, qPCR, and mycoplasma)
• Experience drafting/revising and managing document workflows in CDOCS
• Experience initiating deviations and TRAs in DQMS
  
• Experience executing test methods for microbiology and raw materials 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
• 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.

careers.amgen.com

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.