What You Will Do
- Collaborate with multiple functions within the Thousand Oaks site (Quality Assurance, Quality Control, Engineering, Facilities, Maintenance, Process Development, Process Engineering) to develop understanding of manufacturing operations and planning.
- Complete drug product filling activities.
- Perform initial review of manufacturing batch records.
- Maintain a safe and compliant culture by identifying preventative measures.
- Create and/or revise standard operating procedures.
- Lead continuous improvement initiatives (may be cross-functional).
- Perform data analysis (e.g., SPC, CPV) of critical process parameters and recommend actions to Engineering and/or Process Development.
- Develop finite schedules for tasks (including unit operations).
- Monitor productivity and identify countermeasures impacting cycle time adherence.
- Elevate critical and impactful events to management.
- Apply appropriate systems for job duties (e.g., SAP, QMTS, LIMS).
- Support introduction of new products and technologies.
- Initiate and own quality records, including deviations and CAPA.
What We Expect Of You
Basic Qualifications:
- High school diploma/GED and 2 years manufacturing/operations experience, OR
- Associateโs degree and 6 months manufacturing/operations experience, OR
- Bachelorโs degree.
Preferred Qualifications:
- B.S. in life science or related field.
- 2 years work experience in a GMP environment.
- Proficiency with computer operations (MS Office/Excel).
- Ability to operate specialized equipment/computers.
- Knowledge of regulatory requirements, written procedures, and safety guidelines.
- Ability to evaluate documentation/data per company and regulatory guidelines.
- Ability to interact with inspectors (internal/external).
- Technical writing; strong organization/multi-priority/deadline management.
- Demonstrated written/oral communication and presentation skills.
- Detail oriented; flexible/adaptable to changing priorities.
Benefits (if applicable)
- Total Rewards Plan: health/welfare plans, financial plans, work/life balance, career development; Retirement and Savings Plan, group medical/dental/vision, life/disability insurance, flexible spending accounts; discretionary annual bonus (or sales incentive); stock-based long-term incentives; time-off plans; flexible work models where possible.
Application Instructions
- Apply now via careers.amgen.com.
- No application deadline; applications continue until sufficient or candidate selected.