XX
Manager Quality ControlAmgenPuerto Rico, Texas, United States
XX

Manager Quality Control

Amgen
  • US
    Puerto Rico, Texas, United States
  • US
    Puerto Rico, Texas, United States
Jetzt Bewerben

Über

Career Category QualityJob 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.

MANAGER QUALITY CONTROL - BIOCHEMISTRY LABS (3rd Shift)

What you will do

Let's do this. Let's change the world. In this vital role you will lead all Biochemistry laboratories during the night shift (including Wet Chemistry and HPLC Labs) —ensuring compliant, accurate testing and fostering an impactful team that safeguards product quality and patient safety.

Specific responsibilities include but are not limited to:
  • Lead and develop a successful QC team, fostering a culture of safety, compliance, and continuous improvement.
  • Oversee daily QC operations to ensure timely, accurate, and reliable testing aligned with production schedules.
  • Serve as the QC subject matter expert during audits and inspections, ensuring inspection readiness.
  • Provide technical guidance and troubleshooting support for complex assays and testing issues.
  • Drive training initiatives and ensure team members are appropriately cross-trained for operational flexibility.
  • Monitor assay results and documentation to ensure compliance with cGMP, SOPs, and regulatory standards.
  • Communicate clear expectations on safety, quality, and compliance, addressing discrepancies promptly.
  • Organize and prioritize team tasks based on impact and deadlines, adjusting as needed to meet changing requirements.
  • Use data and dashboards to monitor QC performance metrics, identify trends, and implement improvements.
  • Collaborate with cross-functional stakeholders to align QC activities with broader site and organizational goals.
  • Empower team members through coaching, feedback, and development plans tailored to individual strengths.
  • Promote continuous improvement initiatives to optimize workflows, increase efficiency, and reduce cycle times.
What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Manager Quality Control professional we seek is a dynamic, continuous improvement-focused, people-first leader with these qualifications.

Basic Qualifications:

Doctorate degree

Or

Master's degree and 3 years of Manufacturing Support, Quality Control and/or Laboratory experience

Or

Bachelor's degree and 5 years of Manufacturing Support, Quality Control and/or Laboratory experience

Or

Associate's degree and 10 years of Manufacturing Support, Quality Control and/or Laboratory experience

Or

High school diploma / GED and 12 years of Manufacturing Support, Quality Control and/or Laboratory experience

In addition to meeting at least one of the above requirements, you must have experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above

Preferred Qualifications:

  • Educational background in Life Sciences, Chemistry, Biochemistry, or related fields.
  • Experience in Quality and/or Laboratory operations within a GMP environment.
  • Expertise in overseeing biochemistry laboratory operations, including Wet Chemistry and HPLC testing.
  • Strong knowledge of analytical techniques such as HPLC, TOC, UV spectroscopy, pH, conductivity, appearance, color, clarity, polysorbate, physical methods, .
  • Familiarity with laboratory systems such as LIMS, LMES, CIMS, and Empower for HPLC data management.
  • Knowledge of method
  • Puerto Rico, Texas, United States

Sprachkenntnisse

  • English
Hinweis für Nutzer

Dieses Stellenangebot stammt von einer Partnerplattform von TieTalent. Klicken Sie auf „Jetzt Bewerben“, um Ihre Bewerbung direkt auf deren Website einzureichen.