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Job Description

HOW MIGHT YOU DEFY IMAGINATION?

You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.

Manager Quality Control

Live

What you will do

Let’s do this. Let’s change the world. In this vital role you will be responsible for activities including analytical testing, characterization, data management and trend analysis, laboratory investigations, and change control in a dynamic team environment.

Responsibilities:

• Responsible for leading and advising staff for assigned functional area.
• Responsible for providing Quality oversight to ensure that operations and products are tested in accordance to current Good Manufacturing Practices (cGMP) and other applicable regulations.
• Ensure that facilities, equipment, materials, organization, processes, procedures and products align with cGMP practices and other applicable regulations.
• Perform review, approval and tracking of cGMP processes, procedures, documents and records, including but not limited to nonconformance records, CAPAs, Change Control records and validations.
• Support Continual Improvement initiatives, programs and projects.
• Ensure that changes that could potentially impact product quality are assessed according to procedures.
• Ensure that deviations from established procedures are investigated and documented per procedures. Ensure that testing records are complete, accurate, and documented according to written procedures and cGMP requirements.
• Collaborate cross functionally as needed to ensure the Quality Management System processes are carried out in accordance with established procedures.
• Represent the quality unit during audits and inspections, as needed.
• Support internal/external audits and inspections as part of the audit/inspection management team, as needed.

What we expect of you

We are all different, yet we all use our outstanding contributions to serve patients. The Quality Control professional we seek is a Manager with these qualifications.

• Advanced Degree in Scientific Field
• Solid understanding in Protein separation (Liquid Chromatography), Bioassay and ELISA Laboratory techniques
• Familiarity with the technology transfer process. Experience with validating analytical methods and ensuring that project deliverables meet established timelines.
• Strong level of analytical skills to evaluate and interpret data to arrive at logical and quality-minded conclusions.
• Experience applying problem-solving tools for root cause analysis.
• Proven leadership capabilities and experience applying GMP requirements in a Quality Control setting
• Demonstrated ability to develop, coach and mentor employees
• Excellent interpersonal, verbal and written communication skills with all levels within the organization
• Experience with successfully managing a team and delivering results in fast-paced and dynamic work environment

Thrive

Some of the vast rewards of working here

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

• Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
• A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
• Generous Total Rewards Plan—comprising health, finance and wealth, work/life balance, and career benefits—with compensation and benefits rated above 4 stars (out of 5) on Glassdoor

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

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