Associate Manufacturing

Role Summary

Associate Manufacturing at Amgen. This role collaborates with multiple functions within the Thousand Oaks site to develop a deep understanding of manufacturing operations and planning activities, while supporting the introduction of new products and technologies and maintaining a safe, compliant culture.

Responsibilities

• Completing drug product filling 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, which may be cross-functional in nature
• Performing data analysis (e.g., SPC, CPV) of critical process parameters and making recommendations to Engineering and/or Process Development teams
• Developing finite schedule for tasks including, but not limited to unit operations
• Monitoring productivity and identifying countermeasures for issues impacting cycle time adherence
• Elevating critical and impactful events to management
• Applying appropriate systems for job duties (SAP, QMTS, and LIMS etc.)
• Supporting the introduction of new products and technologies into the facility
• Initiating and owning quality records, including but not limited to non-conformances (NC), Corrective/Preventative Actions (CAPA)

Qualifications

• Required: High school diploma / GED and 2 years of Manufacturing experience OR Associate’s degree and 6 months of Manufacturing experience OR Bachelor's degree
• Preferred: B.S. in a life science or related field
• Preferred: 2 years of work experience in a GMP environment
• Preferred: Ability to perform computer operations, such as navigating MS Office and Excel
• Preferred: Ability to operate specialized equipment and computers as appropriate to the individual area
• Preferred: Ability to adhere to regulatory requirements, written procedures and safety guidelines
• Preferred: Ability to evaluate documentation/data according to company and regulatory guidelines
• Preferred: Ability to interact with inspectors (internal and external)
• Preferred: Technical writing capabilities
• Preferred: Ability to organize work, handle multiple priorities and meet deadlines
• Preferred: Demonstrated written and oral communication skills
• Preferred: Presentation capabilities
• Preferred: Detail oriented as well as flexible and adaptable to changing priorities and requirements

Education

• B.S. in a life science or related field (preferred)