Senior Associate Manufacturing (Swing Shift 2pm - 11pm)

Role Summary

Senior Associate Manufacturing on the Swing Shift (2pm - 11pm) at Amgen's Thousand Oaks site. You will collaborate with multiple functions across Quality Assurance, Quality Control, Engineering, Facilities, Maintenance, Process Development, and Process Engineering to understand manufacturing operations and planning activities, while supporting compliant and efficient production.

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, 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 Deviations and Corrective/Preventative Actions (CAPA)

Qualifications

• Required: Master's degree OR Bachelor's degree and 6 months of GMP/GDP experience OR Associate’s degree and 2 years of GMP/GDP experience OR High school diploma / GED and 4 years of GMP/GDP experience
• 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 ability to navigate in 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