Join Amgens Mission of Serving Patients
At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.
Since 1980, weve 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. As a member of the Amgen team, youll 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 lie within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
QC Specialist
What you will do
Lets do this. Lets change the world.
n this vital role you will sample and perform data management for incoming raw materials from global sites as well as samples from manufacturing at ARI.
Overseeing the stability program and retain samples including forecasting testing schedules. Reviewing and authorizing documents, test samples, lot disposition, contract lab testing and results entry/approval. Provide leadership on the QC Stability shipping team as well as technical support for the QC testing teams. Purchase Requisition and tracking of contract laboratory testing against purchase orders.
In addition to the above tasks, the QC Specialist will perform the following:
Support and perform QC laboratory investigations and audits as necessary.
Support daily activities including aliquoting of samples, raw material receipt, inventory and disposable of authorized samples.
Support the global network for stability program.
Support and document trending analysis, validation protocols/reports, and change controls
Generate complete, accurate, and concise laboratory documentation using electronic systems, such as LMES, LIMS, CIMS and laboratory notebooks.
Operate and maintain specialized laboratory equipment and instrumentation.
Own and document QC laboratory investigations and audits as necessary.
Lead the team to ensure the daily/weekly tasks are performed
Perform general laboratory housekeeping activities and safety inspections
Maintain training compliance and proficiency
At all times, comply with safety guidelines, cGMPs and other applicable regulatory requirements.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a self-starter with these qualifications.
Basic Qualifications:
High school diploma / GED and 10 years of Quality or Operations experience OR
Associates degree and 8 years of Quality or Operations experience OR
Bachelors degree and 4 years of Quality or Operations experience OR
Masters degree and 2 years of Quality or Operations experience OR
Doctorate degree
Preferred Qualifications:
Professional work experience in a fast-paced, flexible GMP laboratory.
Leadership ability, support routine and non-routine testing, method and equipment troubleshooting.
Ability to generate, investigate, and close deviations and analytical result assessments in Veeva.
Ability to generate and document validation protocols and reports.
Ability to evaluate data for trends and document corrective actions.
Experience performing aliquoting of samples aseptically.
Operation, maintenance experience with laboratory equipment.
Ability to generate and revise methods and SOPs within CDOCs.
Demonstrated proficiency with electronic systems capturing consumables, testing procedures, results, and investigations (SAP, LIMS, LMES, CIMS, Veeva, etc.).
Ability to generate, update, and close deviations and analytical result assessments in Veeva.
Demonstrated understanding and use of Maximo (Work order System)
Ability to manage and lead Operational Excellence initiatives including Level and Flow, 5S, and Standard Work associated with the testing labs.
Demonstrated written and oral communication skills, project management and presentation skills, and proven ability to manage priorities effectively.
Demonstrated ability to be flexible and adaptable to support business needs.
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, 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.
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.
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.
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.