Specialist QC
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Benefits offered by this job
Job summary
Amgen is seeking a Specialist QC to lead analytical investigations and drive CAPAs within a GMP-compliant quality system. You will partner with QA, Manufacturing, and Process Development to resolve complex quality events, ensuring timely, inspection-ready documentation.
You will contribute to risk assessment, deviation management, and data integrity while supporting regulatory inspections and continuous process improvement.
Qualifications
- Bachelor's degree or higher in a life science; 4+ years in QC/QA within biotech/pharma.
- Experience leading complex investigations (OOS/OOT/deviations).
- Strong knowledge of GMP regulations and data integrity.
Responsibilities
- Lead QC analytical investigations for OOS, OOT, atypical results and deviations.
- Perform root cause analysis and develop CAPAs.
- Coordinate with QA, Manufacturing and Process Development to ensure timely, risk-based investigations.
- Support inspection readiness and audit communications.
Skills
Education
Job description
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 worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. 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.
- Lead Quality Control analytical investigations for Out-of-Specification (OOS), Out-of-Trend (OOT), atypical, and unexpected analytical results.
- Perform scientifically sound root cause analysis and develop effective corrective and preventive actions (CAPAs).
- Ensure investigations are completed accurately, on time, and in compliance with GMP requirements and internal quality standards.
- Own and support deviations, CAPAs, and effectiveness verifications as assigned.
- Review and approve equipment-related change controls, as applicable.
- Partner with Quality Assurance to ensure investigation outcomes are risk-based and inspection-ready.
- May support additional project-based assignments as required.
- Collaborate with Quality Control laboratories, Manufacturing, Process Development, Quality Assurance, Supply Chain, and other functional groups to resolve complex quality events.
- Facilitate effective communication among stakeholders to ensure timely investigation progression and issue resolution.
- Engage subject matter experts as needed to support technically complex investigations.
- Support internal and external audits by clearly communicating investigation findings, root cause, and CAPA effectiveness.
- Maintain complete, accurate, and inspection-ready documentation.
We are all different, yet we all use our unique contributions to serve patients. The dedicated professional we seek is a collaborative teammate with these qualifications.
- High school diploma/GED and 10 years of directly related experience OR
- Associate's degree and 8 years of directly related experience OR
- Bachelor's degree and 4 years of directly related experience OR
- Master's degree and 2 years of directly related experience OR
- Doctorate degree
- Bachelor's degree in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, or another Life Science discipline.
- 58+ years of Quality Control or Quality Assurance experience within the biotechnology or pharmaceutical industry.
- Demonstrated experience leading complex laboratory investigations, including OOS, OOT, atypical results, and laboratory deviations.
- Strong knowledge of GMP regulations, laboratory quality systems, and deviation management processes.
- Experience performing root cause analysis using structured problem-solving methodologies.
- Strong understanding of analytical laboratory techniques, instrumentation, and data integrity principles.
- Experience authoring and managing deviations, CAPAs, change controls, and effectiveness verifications.
- Ability to evaluate technical data, assess risk, and make sound, science-based decisions.
- Strong written and verbal communication skills with the ability to influence cross-functional teams.
- Experience supporting regulatory inspections and responding to auditor inquiries.
- Experience utilizing digital tools, data analytics, or AI-enabled technologies to improve laboratory processes is preferred.
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, well 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.
- 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 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.
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.
Sponsorship
Sponsorship 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 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.
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