Supply Chain Specialist

Supply Chain Specialist - Job Description

Description:

The Supply Chain Specialist will be primarily responsible for ownership and end to end project management of ADL Supply Chain processes and their associated Change Controls, SOPs, monitoring key Supply Chain Department Quality Metrics and resolving supply chain Deviations.

Specific responsibilities (include but are not limited to):

• Provide end to end project management of Supply Chain Change Controls (e.g. Supply Chain, External Warehouse, and Internal Warehouse changes) including generation of project timelines, critical milestones, identifying required resources from support functions, determination of critical path & appropriate sequence of task completion.
• Own, manage and resolve SC Major Deviations and some SC Minor Deviations , leading investigation teams in order to determine root cause, product impact potential, and Corrective & Preventative Actions (CAPA), and CAPA EVs.
• Providing support and technical guidance to others in SC who own and manage Minor Deviations, CAPAs, CAPA EVs. Working closely with all SC sub-functions (Warehouse Operations, Warehouse Support, Master Data & Procurement, Short-Term Planning, Product Planning, and, Strategic Planning), Quality, Manufacturing, Inspection and Packaging.
• Writing Technical Deviation Reports, Risk Assessment Reports, and managing review and approval cycles with key stakeholders.
• Develop, review and update Supply Chain Standard Operating Procedures (SOPs) working with the relevant owners and SMEs.
• Develop protocols for execution in Supply Chain in support of change controls, deviations & troubleshooting investigations with support from relevant SMEs.
• Provide technical (Root Cause Analysis) RCA guidance to colleagues on EHS, quality and business processes.
• Trend analysis of Deviations quality system deliverables relating to Supply Chain maintaining oversight of department milestones (CAPA’s, CAPA EVs, change controls and deviations).
• Assisting as needed in audits by external agencies in answering questions related to deviations and change controls.
• Engagement with global network Supply Chain leads along with local ADL resources as required.
• Assuring appropriate escalation to various levels of management if timeline requirements for deviation processing are exceeded.
• Performing other duties as required by SC Management.

Qualifications:

• Bachelor's Degree in Science or Engineering and 5+ years of directly related experience in a biotech/pharma manufacturing or manufacturing support role (e.g. process development, engineering, quality, supply chain), OR ,
• Associate's Degree in Science or Engineering and 8+ years of directly related experience in a biotech/pharma manufacturing or manufacturing support role (e.g. process development, engineering, quality, supply chain).
• Experience with investigations into quality deviations and determination of product impact potential, root cause, and corrective actions.
• Experience in managing multiple, competing priorities in a fast-paced environment.
• Strong technical writing and presentation skills.
• Ability to be flexible and manage change.
• Ability to communicate and collaborate with technical and management staff.

Preferred Qualifications:

• Experience interacting with representatives of regulatory agencies.
• Proficient in viewing of SAP ERP.
• Advanced RCA Methods experience.
• 6-Sigma / Lean Yellow Belt certification.

Supply Chain Specialist - Job Description

Description:

The Supply Chain Specialist will be primarily responsible for ownership and end to end project management of ADL Supply Chain processes and their associated Change Controls, SOPs, monitoring key Supply Chain Department Quality Metrics and resolving supply chain Deviations.

Specific responsibilities (include but are not limited to):

• Provide end to end project management of Supply Chain Change Controls (e.g. Supply Chain, External Warehouse, and Internal Warehouse changes) including generation of project timelines, critical milestones, identifying required resources from support functions, determination of critical path & appropriate sequence of task completion.
• Own, manage and resolve SC Major Deviations and some SC Minor Deviations , leading investigation teams in order to determine root cause, product impact potential, and Corrective & Preventative Actions (CAPA), and CAPA EVs.
• Providing support and technical guidance to others in SC who own and manage Minor Deviations, CAPAs, CAPA EVs. Working closely with all SC sub-functions (Warehouse Operations, Warehouse Support, Master Data & Procurement, Short-Term Planning, Product Planning, and, Strategic Planning), Quality, Manufacturing, Inspection and Packaging.
• Writing Technical Deviation Reports, Risk Assessment Reports, and managing review and approval cycles with key stakeholders.
• Develop, review and update Supply Chain Standard Operating Procedures (SOPs) working with the relevant owners and SMEs.
• Develop protocols for execution in Supply Chain in support of change controls, deviations & troubleshooting investigations with support from relevant SMEs.
• Provide technical (Root Cause Analysis) RCA guidance to colleagues on EHS, quality and business processes.
• Trend analysis of Deviations quality system deliverables relating to Supply Chain maintaining oversight of department milestones (CAPA’s, CAPA EVs, change controls and deviations).
• Assisting as needed in audits by external agencies in answering questions related to deviations and change controls.
• Engagement with global network Supply Chain leads along with local ADL resources as required.
• Assuring appropriate escalation to various levels of management if timeline requirements for deviation processing are exceeded.
• Performing other duties as required by SC Management.

Qualifications:

• Bachelor's Degree in Science or Engineering and 5+ years of directly related experience in a biotech/pharma manufacturing or manufacturing support role (e.g. process development, engineering, quality, supply chain), OR ,
• Associate's Degree in Science or Engineering and 8+ years of directly related experience in a biotech/pharma manufacturing or manufacturing support role (e.g. process development, engineering, quality, supply chain).
• Experience with investigations into quality deviations and determination of product impact potential, root cause, and corrective actions.
• Experience in managing multiple, competing priorities in a fast-paced environment.
• Strong technical writing and presentation skills.
• Ability to be flexible and manage change.
• Ability to communicate and collaborate with technical and management staff.

Preferred Qualifications:

• Project Management experience.
• Experience interacting with representatives of regulatory agencies.
• Proficient in viewing of SAP ERP.
• Advanced RCA Methods experience.
• 6-Sigma / Lean Yellow Belt certification.

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.