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Join Amgen’s Mission of Serving Patients. In this dynamic role you will collaborate with multiple functions within the Thousand Oaks site on a routine basis in a dynamic environment (Quality Assurance, Quality Control, Engineering, Facilities, Maintenance, Process Development, Process Engineering, etc.) while developing a deep understanding of the manufacturing operations and planning activities within the facility.
Job Responsibility:
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).
Requirements:
High school diploma / GED and 2 years of Manufacturing experience
Associate’s degree and 6 months of Manufacturing experience
Bachelor’s degree
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
Ability to operate specialized equipment and computers as appropriate to the individual area
Ability to adhere to regulatory requirements, written procedures and safety guidelines
Ability to evaluate documentation/data according to company and regulatory guidelines
Ability to interact with inspectors (internal and external)
Technical writing capabilities
Ability to organize work, handle multiple priorities and meet deadlines
Demonstrated written and oral communication skills
Presentation capabilities
Detail oriented as well as flexible and adaptable to changing priorities and requirements.
Nice to have:
B.S. in a life science or related field
2 years of work experience in a GMP environment
Ability to perform computer operations, such as ability to navigate in MS Office and Excel
Ability to operate specialized equipment and computers as appropriate to the individual area
Ability to adhere to regulatory requirements, written procedures and safety guidelines
Ability to evaluate documentation/data according to company and regulatory guidelines
Ability to interact with inspectors (internal and external)
Technical writing capabilities
Ability to organize work, handle multiple priorities and meet deadlines
Demonstrated written and oral communication skills
Presentation capabilities
Detail oriented as well as flexible and adaptable to changing priorities and requirements.
What we offer:
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