Sr. Associate Quality Assurance AML 14 - Night Shift

Amgen; Juncos (PR); On-site; USD 85,000 - 130,000; Full time

Benefits offered by this job

Retirement plan

Medical, dental & vision

Life & disability insurance

Annual bonus

Stock-based incentives

Site shutdown

Job summary

Amgen seeks a Sr. Associate Quality Assurance AML 14 to oversee manufacturing QA and ensure adherence to cGMP and cGLP requirements. The role involves 24/7 support with non-standard schedules, including weekends and holidays, and participation in continuous improvement initiatives.

Your responsibilities include auditing, deviation investigations, batch record reviews, and system queries using Trackwise, SAP, and Veeva. Strong English communication and problem‑solving abilities are essential.

Qualifications

• 4 years of quality assurance work experience with HS/GED
• Or 2 years with Associate’s degree
• Or 6 months with Bachelor’s degree
• Master’s degree also acceptable
• Strong GMP/cGMP knowledge and documentation skills

Responsibilities

• Provide on‑site QA support to manufacturing and ensure cGMP compliance
• Monitor changes for potential impact on product quality
• Participate in internal plant audits and investigations
• Perform sampling plans and batch records reviews
• Use Trackwise, SAP, and Veeva for QA tasks
• Collaborate with operations to resolve discrepancies

Skills

Quality mindset

Problem solving

English writing/communication

Independent and collaborative work

Time management

Attention to detail

Education

Bachelor’s degree in Life Sciences or Engineering

Master’s degree

Bachelor’s degree

Associate’s degree

High school/GED

Tools

Trackwise

EBR

SAP

DQMS

LIMS

Veeva Systems

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. 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.

Sr. Associate Quality Assurance AML 14

What you will do

Let’s do this. Let’s change the world. In this vital role, you will be part of a department that provides 24/7 operational support through non‑standard work schedules, including weekends and holidays. In this role you will ensure the integrity and compliance of materials and processes that support the delivery of high‑quality, life‑impacting products.

Specific responsibilities include but are not limited to:

• Responsible for providing on‑site support to manufacturing areas and Quality oversight to ensure that operations for clinical and licensed pharmaceutical products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Laboratory Practices (cGLP), and other applicable regulations
• Ensures that facilities, equipment, materials, organization, processes, procedures and products stay in sync with cGMP, cGLP practices, and other applicable regulations
• Actively engage in Continuous Improvement initiatives, programs and projects
• Ensures that changes that could potentially impact product quality are assessed according to procedures
• Ensures that deviations from established procedures are investigated and detailed per procedures
• Ensures that production records and testing results are complete, accurate, and detailed according to written procedures, cGMP, and cGLP requirements
• Participate in internal plant audits
• Assist in Investigations
• Perform sampling plans for all manufactured products, batch records review, SAP transactions, Trackwise system queries, deviations management and Veeva System queries
• Participate in triage process and Decision Making Process (DAI)
• Compliance review of batch record elements (e.g., MPs, MSRs) and identification of discrepancies
• Work with operations to resolve basic compliance discrepancies

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Sr. Associate Quality Assurance professional we seek is an individual contributor with these qualifications.

Basic Qualifications:

High school/GED and 4 years of quality Assurance work experience

OR

Associate’s and 2 years of quality Assurance work experience

OR

Bachelor’s and 6 months of quality Assurance work experience

OR

Master’s Degree

Preferred Qualifications:

• Educational background in Life Sciences or Engineering.
• GMP knowledge with ability to interpret and apply in routine cases.
• Experience with Trackwise, EBR, SAP, DQMS, LIMS systems and Veeva Systems.
• Strong technical writing and communication skills in English; bilingual (English/Spanish).
• Ability in problem‑solving and providing solutions.
• Ability to evaluate documentation and operations per company guidelines.
• Intermediate proficiency in Word, Excel, PowerPoint, and database tools.
• Ability to work independently and collaboratively, prioritizing tasks and meeting deadlines.
• Basic understanding of statistical concepts and analytical methods for process monitoring.
• Ability to identify discrepancies in aseptic practices, documentation, and processes.
• Ability to communicate effectively, challenge appropriately, elevate concerns, and collaborate with Manufacturing and other functions.
• Strong critical thinking and Quality mindset with the ability to make sound, risk‑based decisions.

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well‑being.

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental & vision coverage, and life & disability insurance
• 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 and an annual site shutdown
• Flexible work models where possible. Refer to 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.

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 you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

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.