Sr. Associate Quality Assurance AML 14 - Night Shift

Amgen; Juncos (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

Amgen is seeking a Sr. Associate Quality Assurance AML 14 to provide on-site QA oversight for manufacturing activities, ensuring compliance with cGMP, cGLP, and regulatory requirements.

The role involves evaluating changes, investigating deviations, and supporting continuous improvement across processes and documentation. The ideal candidate has a strong background in Life Sciences or Engineering, with GMP knowledge and experience using Trackwise, SAP, and Veeva Systems.

Qualifications

• High school/GED with 4 years QA experience.
• Bachelor’s and 6 months of QA experience.
• Master's Degree.
• Educational background in Life Sciences or Engineering.
• GMP knowledge and ability to interpret/apply in routine cases.
• Experience with Trackwise, EBR, SAP, DQMS, LIMS, Veeva Systems.
• Strong English writing and communication; bilingual English/Spanish.
• Ability to solve problems and provide solutions.
• Ability to evaluate documentation per company guidelines.
• Statistical concepts for process monitoring.
• Identify discrepancies in aseptic practices and documentation.

Responsibilities

• Provide on-site support to manufacturing areas with QA oversight to ensure compliance with cGMP/cGLP and other regs.
• Ensure facilities, equipment, materials, and processes comply with cGMP/cGLP requirements.
• Engage in Continuous Improvement initiatives and projects.
• Assess changes potentially impacting product quality per procedures.
• Investigate deviations and document per procedures.
• Ensure batch records and testing results are complete and accurate.
• Participate in internal plant audits and investigations.
• Perform sampling plans, batch records review, SAP/Trackwise queries, deviations management.

Skills

Technical writing

Communication

Bilingual (English/Spanish)

Problem-solving

Quality mindset

Statistical concepts

Analytical methods

Education

High school/GED + 4y QA experience

Associate’s + 2y QA experience

Bachelor’s + 6 months QA experience

Master's Degree

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, escalating 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.

In addition to the base salary, Amgen offers a Total Rewards Plan comprising 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 including:

• 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

Sponsorship

Sponsorship for this role is not guaranteed.

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.

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.