Sr Associate Quality Control - Microbiology

Amgen; Juncos (PR); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Retirement and Savings Plan

Medical, Dental & Vision insurance

Stock-based incentives

Discretionary bonus program

Flexible work models

Job summary

Amgen in Puerto Rico is seeking a Sr. Associate Quality Control- Microbiology to join our team and help ensure the quality, safety, and consistency of our products before they reach patients.

You will perform critical analytical testing, maintain strict documentation, and act as a subject matter expert on cGMPs and SOPs while mentoring peers. The role may require non-standard shifts and collaboration across QA, manufacturing, and quality systems.

Qualifications

• Master’s Degree in Microbiology, Biotechnology, or related field.
• Experience or coursework in GMP environment.
• Written and oral communication skills in English and Spanish.
• Ability to understand and apply regulatory requirements.

Responsibilities

• Perform routine and advanced analytical testing with precision per SOPs.
• Maintain documentation in LIMS, CIMS, LMES with Good Documentation Practices.
• Serve as SME on cGMPs and SOPs; mentor peers.
• Troubleshoot testing issues and escalate as needed.
• Review lab results for accuracy and data integrity.
• Participate in method validation and verification activities.
• Manage samples with proper handling and tracking.
• Support continuous improvement and SOP revisions.
• Communicate results clearly to team and stakeholders.
• Prioritize tasks to meet deadlines and balance workload.

Skills

Bilingual English/Spanish

Project management

Strong organizational skills

Regulatory compliance knowledge

Technical writing skills

Quality testing expertise

Education

Master’s Degree

Bachelor’s Degree + 6 months Quality/Lab experience

Associate’s Degree + 2 years Quality/Lab experience

High school/GED + 4 years Quality/Lab experience

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 Control- Microbiology

What you will do

Let’s do this. Let’s change the world. In this vital role you will perform critical testing and analysis to ensure the quality, safety, and consistency of our products before they reach patients.

Specific responsibilities include but are not limited to:

• Perform routine and sophisticated analytical testing with precision and accuracy, ensuring compliance with SOPs and regulatory standards.
• Maintain meticulous documentation in systems such as LIMS, CIMS, and LMES, following Good Documentation Practices.
• Serve as a subject matter expert on cGMPs and SOPs, mentoring peers and modeling adherence to safety and quality protocols.
• Troubleshoot testing issues independently and bring up complex problems to management or technical leads as needed.
• Review laboratory results for accuracy and compliance, contributing to data integrity and product quality.
• Participate in method validation and verification activities to support the lab’s analytical capabilities.
• Manage samples efficiently, ensuring proper handling, tracking, and documentation throughout the testing process.
• Support continuous improvement initiatives by identifying inefficiencies and contributing to SOP revisions.
• Communicate test results and task updates clearly and concisely to team members and stakeholders.
• Demonstrate strong time management by prioritizing tasks, meeting deadlines, and supporting team workload balance.

What we expect of you

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

Basic Qualifications:

Master’s Degree

Or

Bachelor’s Degree + 6 months of Quality and/or Laboratory work experience

Or

Associate’s Degree + 2 years of Quality and/or Laboratory work experience

Or

High school/GED + 4 years of Quality and/or Laboratory work experience

Preferred Qualifications:

• Educational background in Microbiology, Biotechnology or Medical Technologies.
• Laboratory experience in a GMP environment within the Pharmaceutical and/or Biotech industry
• Good communications and presentation skills in English and Spanish
• Project management skills
• Strong organizational skills, including ability to follow assignments through to completion
• Enhanced skills in leading, influencing and negotiating
• Knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation and process development
• Basic Knowledge and skills of word processing, presentations, and spreadsheet applications
• Available to support non-standard shift (including 1st, 2nd, 3rd and weekend shifts)
• Ability to understand, apply, and evaluate basic chemistry, biology, physical principles and mathematics
• Ability to adhere to regulatory requirements, written procedures and safety guidelines
• Evaluate documentation/data according to company and regulatory guidelines
• to organize work, handle multiple priorities and meet deadlines
• Written and oral communication skills
• Technical writing capabilities

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.

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 & 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
• 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.

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.