Specialist External Manufacturing

Description:

Flexible Commuter

Must have skills:

• Project management.
• Technical writing.
• Understanding of Good Manufacturing Practices in the Biopharmaceutical, Pharmaceutical, or Medical Device industries.
• Experience or knowledge of operations (in the three industries listed above).
• Quality management skills including previous experience managing quality records in Trackwise, Veeva or a comparable quality system.
• Previous experience in inventory management systems such as SAP.

Job Description:
The Specialist, Manufacturing will serve as the primary point of contact and external supply quality record owner for Amgen’s sites in Ireland (Dun Laoghaire) and the Netherlands (Breda). The main responsibility of this role is to manage quality records for events associated with the Secondary Packaging and Device categories, while also providing support for events in additional categories as needed. This support includes conducting regular site visits to evaluate supplier-related events and developing strong working relationships with the external supply support teams at each site.

In terms of record ownership, the Specialist, Manufacturing is responsible for independently managing and executing all processes related to deviations (both minor and major), Corrective and Preventive Actions (CAPAs), CAPA Effectiveness Verifications, Supplier Event Notifications, Supplier Investigations (EN/SICAR), and Change Control quality records. The role also requires applying process, operational, and scientific expertise, as well as basic compliance knowledge and analytical and troubleshooting abilities, to support quality records originating from manufacturing sites throughout the Amgen network. Additionally, the Specialist, Manufacturing will represent External Supply on cross-functional teams and ensure quality records are closed promptly.

Responsibilities:
Responsibilities include, but are not limited to the following:

• Address and close quality records (Deviations, Corrective and Preventive Actions (CAPAs), CAPA-Effectiveness Verifications, Supplier Event Notifications and Investigations (EN/SICAR), and Change Control) under the company's quality management system procedures and ensure compliance with regulatory agency requirements.
• Mentoring and leading of peers in functional areas and Quality Operations in the implementation of investigations of varying complexity
• Facilitation of cross-functional teams (internal and external to the site) with the goal of achieving robust and detailed investigation performance
• Monitor, author, and investigate deviations owned by External Supply and implements corrective / preventive actions. Partner cross-functionally across the site to ensure maturity and execution of robust Deviations / CAPA process.
• Lead investigation teams to identify meaningful root causes and robust corrective and preventative actions by effectively utilizing advanced root cause analysis tools (Causal Factor Analysis, Fault Tree Analysis, Kepner-Tregoe, etc.)
• Manages closure of multiple quality records simultaneously and in a timely matter (Deviations, Change Controls, ENs, SICARs, CAPA, CAPA-EV).
• Work closely with the suppliers and External Supply peers to address and close critical investigations and Corrective Actions
• Build and present quality records summaries for Senior Management review. Provide timely and comprehensive process and status updates to senior management.
• Communication of Quality records status to Senior Leadership in multiple forums (as requested); maintaining the metric reporting for performance.

• May participate in regulatory inspections
• Participate in the assessment or implementation of continuous improvement projects or initiatives.

Basic Qualifications:

• Doctorate degree
• Master’s degree & 3 years of directly related experience
• Bachelor’s degree & 5 years of directly related experience
• Associate’s degree & 10 years of directly related experience
• High school diploma / GED & 12 years of directly related experience

Preferred Qualifications:

• 3+ years related work experience (manufacturing, process development, or quality assurance) in Biotech or pharmaceutical industry with progressively increasing responsibility and demonstrated experience in compliance, problem solving, critical thinking, project management, and quality systems.
• Demonstrated ability to coordinate and effectively participate in cross-functional project teams and deliver on schedule.
• Experience in leading multiple, contending priorities in a fast-paced environment with minimal direction.
• Excellent communication skills, both written and verbal (including technical writing and presentation skills) with ability to collaborate productively with technical and senior management staff.
• Demonstrated ability to work autonomously, present data in an organized and logical manner, meet deadlines, prioritize work and communicate effectively.
• Experience presenting to and interacting with representatives of regulatory agencies.
• Demonstrated ability to navigate through ambiguity and provide a structured problem-solving approach.
• Proficient with Microsoft Office Tools (Word; Excel; PowerPoint; Project, Teams, Outlook)
• Interpersonal and facilitation skills necessary to forge consensus among challenging client interests while ensuring objectives are met.
• Ability to tactfully negotiate and positively influence peers and executive leadership.
• Demonstrated ability to deliver results through living the Amgen values.
• Strong negotiation skills when working with external suppliers and internal team members.
• Ability to maintain remote working relationships with colleagues at other Amgen sites.