Career CategoryQuality
Job DescriptionSenior Associate Quality ControlWhat you will doLet's do this. Let's change the world! In this vital role, you will support:
- Sample Plan templating, logging and compilation of LIMS packets needed to support manufacturing
- Hosting and participating in cross-functional, cross-site, and external meetings to support internal and external testing.
- Management support of Contract Laboratory testing as required to support the manufacturing of Amgen products to ensure testing is completed on time per Quality Agreements and Disposition Due Dates. Support includes tracking of samples, data entry and issue resolution.
- Certificate of Analysis generation and Lot tracking for testing that supports disposition of product and raw materials
- Support Method Transfer and Validation activities in support of manufacturing timelines
- Document management
What we expect of youWe are all different, yet we all use our unique contributions to serve patients. The professional we seek is an individual with the following qualifications:
Basic Qualifications: - High school/GED + 4 years of Quality experience OR
- Associate's + 2 years of Quality experience OR
- Bachelor's degree and 6 months of Quality or Operations experience
- Master's degree
Preferred Qualifications: - Professional work experience in a fast-paced, flexible GMP laboratory.
- Ability to generate and revise methods, reports and SOPs within CDOCs.
- Demonstrated proficiency with electronic systems (LIMS, LMES, CIMS, CDOCS, etc.).
- Ability to generate, update, triage, and close deviations and analytical test result assessments.
- Ability to manage and lead Operational Excellence initiatives including 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 of usAs 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 where possible. Refer to the Work Location Type in the job posting to see if this applies.
Salary Range78,724.45USD -106,509.55 USD
