Manager Quality Control
7 days ago
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 - HPLC LABS (2nd Shift)
What you will doLet's do this. Let's change the world. In this vital role you will lead the HPLC Labs during the 2nd shift —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.
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 Biochemistry Laboratory operations within a GMP environment, preferably in HPLC testing.
- Strong knowledge of analytical techniques such as HPLC
- Familiarity with laboratory systems such as LIMS, LMES, CIMS, and Empower for HPLC data management.
- Knowledge of method transfer and validation activities.
- Proven ability to optimize schedules and improve laboratory efficiency and productivity.
- Strong people management skills, including team development, coaching, and engagement.
- Demonstrated ability to balance working both independently and in teams, driving cross-shift collaboration and efficiency with other managers within the organization
- Highly collaborative leadership style with experience working effectively across diverse departmental groups.
- Excellent communication skills (written and verbal) in English and Spanish; ability to facilitate and present effectively.
As we work to develop treatments that take care of others, we also work to care for our teammates' professional and personal growth and well-being.
In addition to the base salary, Amgen offers a Total Rewards Plan comprising 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 including:
- 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 and an annual site shutdown
- 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.
SponsorshipSponsorship 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 you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
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.
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