Associate Manufacturing (Swing Shift 2pm-11pm)

Amgen Inc.•Thousand Oaks, CA

47d

About The Position

Join Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Associate Manufacturing What you will do Let's do this! Let's change the world! 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. Responsibilities of the role include:

Requirements

Bachelor's degree OR Associate's degree and 6 months of GMP/GDP experience OR High school diploma / GED and 2 years of GMP/GDP experience

Nice To Haves

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.

Responsibilities

Performing drug product manual visual inspection activities, respectively
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)

Benefits

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
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible.

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