Sr Associate Quality Control - Microbiology

Amgen • Juncos, PR

1d

About The Position

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.

Requirements

• Master’s Degree
• Bachelor’s Degree + 6 months of Quality and/or Laboratory work experience
• Associate’s Degree + 2 years of Quality and/or Laboratory work experience
• High school/GED + 4 years of Quality and/or Laboratory work experience

Nice To Haves

• 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

Responsibilities

• 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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level