Career CategoryManufacturing
Job DescriptionSenior Associate Manufacturing (CAPA/EV)What you will doLet's do this. Let's change the world. In this vital role you will support deviations by owning the associated CAPA and EV records in the Amgen Thousand Oaks Manufacturing Clinical Supply Organization, including Drug Substance and Drug Product manufacturing, Supply Chain, Drug Product Assembly/Packaging, Quality Control, and Warehouse Operations. This individual will play an integral role collaborating within a cross-functional team that includes Manufacturing, Quality Assurance, Process Engineering, Process Development, Analytical Sciences, Quality Sciences, Quality Control, Supply Chain, and Regulatory Affairs.
Responsibilities:
- Manage deviation investigation CAPAs and EVs, including assembling teams, and compliant documentation of all findings.
- Drive improvements to the investigation process
- Defend investigation CAPAs/EVs to regulatory inspectors and internal auditors
- Present complex topics clearly to large and small groups at all levels in the company
- Build effective relationships across functions
- Clear and concise technical writing
What we expect of youWe are all different, yet we all use our unique contributions to serve patients. The professional we seek is a go getter with these qualifications.
Basic Qualifications:- Master's degree OR
- Bachelor's degree and 6 months of manufacturing experience OR
- Associate's degree and 2 years of manufacturing experience OR
- High school diploma / GED and 4 years of manufacturing experience
Preferred Qualifications:- 4+ years related work experience (manufacturing, process development, or quality assurance) in biotech or pharmaceutical industry with progressively increasing responsibility
- Degree in Science or Engineering
- Experience leading teams
- Demonstrated project management ability
- Excellent written and verbal communication skills
- Ability to work in a team matrix environment and build relationships with partners
What you can expect from 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, including remote and hybrid work arrangements, where possible
Apply now and make a lasting impact with the Amgen team.
careers.amgen.comIn 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.
