Manager Quality Control ((Tuesday-Friday from 9:45pm – 8:15am)

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

The Quality Control (QC) Manager will be responsible for leading the QC Night Shift “Team D” (Tuesday-Friday from 9:45pm – 8:15am).  The QC manager will be responsible for oversight and execution of routine tasks and testing including but not limited to: time sensitive samples from Manufacturing (Titer/ MMV/ Mycoplasma/ Endotoxin/ Bioburden/ TOC/ Conductivity), Centralized Raw Material testing (compendial testing & microbiology), Environmental Monitoring and Critical Utilities, Sample Receipt and Aliquot.

What you will do

Leading, supervision, and development of staff

• Collaborates across QC to coordinate the weekly testing schedule
• Prioritizes daily work tasks
• Partner with cross-functional areas (Mfg, F&E) to understand sample schedules and timely test result deliverables
• Ensures lab operations comply with applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and Laboratory Controls.
• Provides oversight of quality records including Testing Results Assessment (TRAs), Deviations, and Corrective Actions/ Preventive Actions (CAPAs)
• Owns and reviews-controlled documents, including Standard Operating Procedures, Analytical Methods, Protocols and Reports related to lab activities.
• Collaborates cross functionally as needed to ensure the Quality Management System processes are carried out in accordance with established procedures.
• Alerts senior management of quality, compliance, supply and safety risks.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dedicated professional we seek is a great teammate with these qualifications.

Basic Qualifications:

High school diploma / GED and 12 years of Quality, MFG, or Operations experience
Associate’s degree and 10 years of Quality, MFG, or Operations experience OR
Bachelor’s degree and 5 years of Quality, MFG, or Operations experience OR
Master’s degree and 3 years of Quality, MFG, or Operations experience OR
Doctorate degree

Preferred Qualifications:

Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources

• Proven leadership capabilities and experience applying GMP requirements in a Quality Control setting.
• Experience with general laboratory practices.
• Experience with chromatography techniques (HPLC, UPLC), compendial testing, or microbiology.
• Experience with various laboratory equipment and computer systems
• Strong level of analysis skills to evaluate and interpret data to arrive at logical and quality-minded conclusions. Experience applying problem-solving tools for root cause analysis.
• Excellent interpersonal, written and verbal communication skills with all levels within the organization.
• Experience with supporting staff training, career development and performance management.
• Establishment and review of department goals, strategies and KPIs.
• Ability to work in a team matrix environment and build relationships.
• Identify, lead, and champion innovative projects to advance efficiency and enable LEAN principles across different functions.
• Strong leadership and negotiation skills.
• Innovative thinking and ability to transform work organizations
• Exposure to Operational Excellence initiatives.
• Proven ability to coordinate multi-functional project teams and deliver on schedule.

What you can expect from 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.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

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 and vision coverage, life and disability insurance, and flexible spending accounts
• 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, including remote and hybrid work arrangements, where possible

Apply now and make a lasting impact with the Amgen team!

careers.amgen.com

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Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

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. 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.