BASIC QUALIFICATIONS:

Doctorate degree and 2 years of quality control and/or laboratory experience
OR
Master’s degree and 4 years of quality control and/or laboratory experience
OR
Bachelor’s degree and 6 years of quality control and/or laboratory experience
Or
Associate’s degree and 10 years of quality control and/or laboratory experience
Or
High School diploma / GED and 12 years of quality control and/or laboratory experience

BEYOND THAT, ADDITIONAL PREFERRED QUALIFICATIONS ARE:

• Academic background in Life Sciences.
• 10+ years of professional experience, including at least 4 years in cGMP-regulated environments within Quality Control, Laboratory Operations, Validation, or Quality Assurance.
• Exceptional proficiency in analytical method qualification, validation, and transfer processes as well as their associated international guidance and regulatory requirements.
• Strong technical background with laboratory equipment operation, troubleshooting, maintenance, and optimization in multiple analytical platforms (molecular biology, chemistry and/or microbiology).
• Demonstrated experience managing quality systems, including Change Controls, CAPA, deviations, and investigations.
• Proficient in cGMPs/GLPs, domestic and international regulatory standards, and experienced in regulatory inspection readiness and response.
• Excellent technical writing, facilitation, and verbal communication skills in English; capable of authoring SOPs, protocols, and regulatory documentation clearly and effectively.
• Skilled in data analysis, digital systems (LIMS, Empower), and Microsoft Office applications (Excel, Word, PowerPoint).
• Proven ability to lead cross-functional teams and projects, with strong influencing, organizational, and project management capabilities, including budget oversight and capital project execution.
• Strong commitment to EHS practices and promoting a culture of laboratory safety and compliance.

Let’s do this. Let’s change the world! In this vital role you will be the technical specialist for Amgen Manufacturing Limited, QC Operations. You will serve as a key technical leader supporting the Quality Control (QC) laboratories. You will be responsible for addressing complex technical challenges with cross-functional, multi-site, and external impact. Collaborating across Quality Control, Quality Assurance, Manufacturing, Engineering, and Process Development, your work will be critical in ensuring the robustness and reliability of lab operations.

Specific responsibilities include but are not limited to:

• Technical Expertise & Troubleshooting - Provide hands-on technical guidance and expert-level troubleshooting for analytical assays and laboratory equipment, ensuring high-quality and timely support across QC operations.
• Data & Reporting - Conduct data analysis, generate technical reports, and maintain effective communication with cross-functional technical teams. Follow up on open items and drive issues to resolution.
• Compliance & Safety Leadership - Ensure strict adherence to cGMP, GLP, and safety standards. Drive compliance through the development and implementation of procedures that enhance quality and safety across lab operations.
• Laboratory Optimization - Lead initiatives to improve equipment reliability and maintenance using optimization techniques. Champion programs that elevate laboratory performance and minimize downtime.
• Controlled Documentation - Create, revise, and audit complex controlled documents with potential multi-site impact. Ensure documentation aligns with regulatory and corporate requirements.
• Audit & Inspection Readiness - Lead QC efforts during internal and external inspections. Serve as a key representative and subject matter expert (SME) for laboratory equipment and operations.
• Training & Capability Building - Develop and deliver technical training programs for laboratory staff. Promote knowledge transfer and continuous improvement initiatives.
• Quality Systems Oversight - Manage quality system records, lead laboratory investigations, and support continuous improvement of quality processes.
• Cross-functional Collaboration - Represent QC Operations on cross-functional teams and global initiatives. Independently manage and drive multi-site action items to closure.
• Regulatory Engagement - Support regulatory inspections and responses as an SME within area(s) of responsibility.
• Financial & Vendor Management - Oversee operational financials, including procurement activities, contract execution, and purchase order management for laboratory services and equipment.
• Special Projects - Lead or support strategic projects assigned by management to drive innovation and efficiency.