Amgen Manufacturing Associate in Thousand Oaks, California
This role will lead inspection and testing activities for the Drug Product Manufacturing process. The candidate will provide technical support to the Inspection areas at Amgen as well as being part of the QC network. The input provided will include support of process performance and implementation of process improvement strategies and will include the following:
Acts as an inspection technical expert to provide solutions when troubleshooting inspection issues through the NPI or post-NPI phases.
Inspect syringes and vials for defects
Perform QC type testing for Protein Concentration, Sub-Visible Particle, Endotoxin, etc.
Leads Inspection NPI activities and serves as the Inspection SME.
Interfaces with PD and other Amgen sites to provide robust and coordinated support for manufacturing.
Troubleshoots issues with inspection equipment.
Conducts risk assessment for inspection operations and propose / implement appropriate CAPA.
Identifies and implements operational opportunities for current and new inspection operations.
Responsibilities may include leading cross-site teams to support the above activities, providing recommendations to management.
Development of Validation Plans, IOQs and PQs
Ensuring all aspects of activity within any given Process Validation adheres to required policies and procedures, including safety and training.
Ensure that the Site meets the quality requirements of its customers and applicable regulations FDA, EU & International Standards
Participate in Validation Cross Functional Teams (CFTs) at the site to ensure adherence to required policies and procedures.
Pre-approve and post-approve process validation protocols and assessments from a quality system documentation perspective.
Liaise with PD, Operations, Engineering and external vendors regarding new or amended equipment, which would affect the Validated Process.
Assist in the development of any existing Validation program to ensure continued compliance to the necessary regulations. Input to Site Validation Guidance Documents
Assist in deviation and exception resolution and root cause analysis.
Participate as required in project activities.
Contribute to Product Quality Assessments and process flow documents.
Associate's degree and 4 years of Science, Engineering, Quality experienceor
High school diploma / GED and 6 years of Science, Engineering, Quality experience
Preferred Qualifications .
Bachelor's degree in Science, Engineering or a relevant Quality discipline or 3 years of related experience in Inspection and/or QC testing.
5 + years of experience in support of Commercial Protein Drug Product (DP) processing in specific areas such as Process Characterization, Tech Transfer (to commercial DP sites) or Validation.
Strong skills in applying fundamental engineering and scientific principles to the design and implementation of Inspection processes
Project management skills including the ability to manage multiple projects and evaluate project resource requirements.
Strong knowledge of Quality systems, Drug Product Inspection and Validation.
Demonstrated ability in providing leadership to cross-functional teams to advance complex projects to completion.
Knowledge of applicable Regulatory requirements
Experience with Regulatory inspections desirable
Experience working with teams and influencing decisions
Knowledge of cGMPs and other worldwide regulatory requirements.
Knowledge of inspection processes and vision systems
Knowledge of Knapp studies, inspection equipment qualifications, manual inspection qualifications
Problem solving ability and excellent oral and written communications skills
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.