Associate Manufacturing (Swing Shift 2pm-11pm)
Amgen
Full-time
On-site
Thousand Oaks, CA
Operations
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Role Summary
Associate Manufacturing (Swing Shift 2pm-11pm) at Amgen. The role collaborates with multiple functions within the Thousand Oaks site to develop a deep understanding of manufacturing operations and planning activities, contributing to the production of innovative medicines.
Responsibilities
- Performing drug product manual visual inspection activities
- Performing initial review of manufacturing batch records
- Maintaining a safe and compliant culture by identifying preventative measures
- Creating and/or revising standard operating procedures
- Leading continuous improvement initiatives (cross-functional)
- Performing data analysis (e.g., SPC, CPV) of critical process parameters and recommending actions
- Developing finite schedules for tasks including unit operations
- Monitoring productivity and identifying countermeasures for issues affecting cycle time
- Elevating critical/impactful events to management
- Applying systems for job duties (SAP, QMTS, LIMS)
- Supporting introduction of new products and technologies
- Initiating and owning quality records, including non-conformances and CAPA
Qualifications
- Required: Bachelor’s degree OR Associate’s degree with 6 months GMP/GDP experience OR High school diploma/GED with 2 years GMP/GDP experience
- Preferred: B.S. in life science or related field
- 2 years of GMP environment experience
- Ability to operate computer systems (MS Office/Excel) and specialized equipment
- Ability to adhere to regulatory requirements, procedures, and safety guidelines
- Ability to evaluate documentation/data per company and regulatory guidelines
- Ability to interact with internal and external inspectors
- Technical writing capabilities
- Strong organizational skills, multi-priority handling, and meeting deadlines
- Strong written and verbal communication; presentation skills
- Detail-oriented with flexibility to changing priorities
Skills
- Data analysis and interpretation
- Process documentation and SOP development
- Quality systems and CAPA
- Cross-functional collaboration
- Regulatory compliance and safety
Education
- Bachelor’s or Associate’s degree in a related field preferred; or equivalent GMP/GDP experience