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Job Description

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

At Amgen, our shared mission is to serve patients. Every team member contributes to our ability to consistently deliver high-quality medicines through excellence in operations, compliance, and continuous improvement.

The Manufacturing Senior Associate is responsible for the authoring, revision, coordination, and lifecycle management of Manufacturing controlled documents. This role partners closely with Manufacturing, Quality, Process Development, Engineering, Validation, and other cross-functional stakeholders to ensure procedures and documentation remain accurate, compliant, effective, and inspection-ready.

The individual serves as a key document management and process improvement resource, facilitating complex document revisions and authoring, coordinating stakeholder reviews, driving on-time completion of commitments, and supporting Manufacturing performance through effective documentation practices specifically in DS, DP, or FDP. In some instances may act as the overall business process owner for DS, DP, or FDP. Hours for this role may vary based on global time zones, which could include hybrid hours, on call requirements, and flexible working hours.

Key Responsibilities

Document Authoring & Lifecycle Management

• Author, revise, and maintain controlled GMP documents in collaboration with the document owner. Documents include:
  • Standard Operating Procedures (SOPs)
  • Forms
  • Protocols
  • Reports
  • Global Document Elements (GDEs)
  • Work Instructions
  • Training Documents
  • Other controlled GMP documentation
• Ensure documents comply with Good Documentation Practices (GDP), cGMP requirements, site procedures, and global standards.
• Perform periodic reviews of controlled documents and drive completion of required updates.
• Review existing procedures for accuracy, consistency, and process alignment.
• Identify opportunities to improve document effectiveness, usability, and compliance.

Cross-Functional Coordination

• Facilitate document review meetings and revision workshops with subject matter experts and stakeholders, across various sites in the network
• Coordinate comment resolution across multiple functional groups.
• Consolidate feedback and incorporate approved revisions into final documents.
• Drive stakeholder alignment in partnership with the sponsoring area owner on document content, process changes, and implementation plans.
• Partner with Quality, Validation, Engineering, Manufacturing, and Technical Services to ensure documentation supports operational needs.

Project & Revision Management

• Manage multiple complex document revisions simultaneously.
• Develop and maintain document revision schedules and status trackers.
• Monitor progress against established timelines and commitments.
• Escalate risks, delays, and resource constraints as appropriate.
• Lead efforts to complete high-priority and inspection-related documentation updates.

Metrics & Operational Support

• Generate and analyze documentation performance metrics and reports.
• Track key performance indicators related to document health, overdue reviews, revision cycle times, and compliance commitments.
• Prepare performance metrics for communication to leadership and stakeholders
• Drive actions to improve documentation effectiveness, compliance, and right-first-time performance.
• Support audit and inspection readiness activities through documentation monitoring and reporting, if required.

Continuous Improvement

• Identify opportunities to streamline documentation processes and workflows.
• Participate in process improvement initiatives and digital transformation efforts.
• Recommend and implement solutions that improve document quality, compliance, and efficiency.
• Contribute to standardization efforts across manufacturing organizations and sites.

Basic Qualifications

Graduation with 5 to 9 years of experience

Preferred Qualifications

• Experience in a GMP-regulated manufacturing environment.
• Experience authoring and revising SOPs, protocols, reports, forms, and controlled documentation.
• Strong technical writing and document management skills.
• Experience facilitating cross-functional meetings and stakeholder reviews.
• Knowledge of Good Documentation Practices (GDP) and cGMP requirements.
• Experience using electronic document management systems (e.g., Veeva, CDOCS, EDMS, TrackWise, etc.).
• Ability to manage multiple priorities and deadlines simultaneously.
• Strong project management and organizational skills.
• Experience generating and analyzing operational metrics and performance reports.
• Demonstrated ability to influence stakeholders without direct authority.
• Strong communication, collaboration, and facilitation skills.
• Experience leading continuous improvement initiatives.

Competencies

Consistent with the Manufacturing Senior Associate (GCF 4) competency model, success in this role requires demonstrated capability in:

• Demonstrating Technical Expertise
• Operating with Precision
• Working in Partnership
• Troubleshooting and Solving Problems
• Inspiring High Performance
• Striving for Your Best

Key Measures of Success

• On-time completion of document revisions
• Reduction in overdue document reviews
• Right-first-time document approval rate
• Cycle time for document revision and approval
• Compliance with GMP and documentation standards
• Inspection readiness and audit support effectiveness
• Stakeholder satisfaction
• Continuous improvement implementation and value delivery