Career Category

Quality

Job Description

Sr Associate Quality Compliance

Role Name: Sr Associate Quality Compliance – Process Modeler

Department Name: R&D Quality

Role GCF: 4

ABOUT AMGEN

Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today.

ABOUT THE ROLE

Role Description:

• The Sr Associate Quality Compliance
• Process Modeler gathers and analyses information from a variety of sources (SMEs, documentation, and technical) to create business process models within the Amgen process modeling methodology framework, using specified Visio templates. In addition, the Process Modeler may be expected to facilitate workshops, fact-finding interviews, project management activities, and other necessary activities to gather and synthesize information into their process models.

Roles & Responsibilities:

• Translate subject matter expert and stakeholder discussion into process flows and procedures.
• Lead workshops, interviews and other information gathering activities specifically to derive process structure and measures
• Learn and stay updated on Amgen process modeling methodology (training is provided)
• Learn Visio modeling template usage, structure, and metamodel (training is provided)
• Learn how to use the process management system (training is provided)
• Serve as a modeling subject matter expert and point of contact to support functional and cross-functional stakeholders.
• Know when to escalate process issues and seek resolution
• Collaborate with subject matter experts globally to ensure appropriate stakeholders are included in the development and revision of process models.
• Provide regular status updates to business customers to achieve goals and meet deadlines.
• Establish timelines and report regularly on progress, obstacles, and execution to the Amgen designated representative.
• Work with documentation, training, and other project team members in the formulation of plans and activities to support project implementation.

Basic Qualifications and Experience:

• Masters Degree in Sciences or related field with 3-5 years exp in Pharmaceutical/Biotechnology/Clinical research

Functional Skills:

Must-Have Skills:

• Able to translate discussion into process flows and process documentation.
• Understanding of translating process models into written documentation, SOPs, and other controlled documents.
• Ability to facilitate teams toward a common vision or goal.
• Advanced skill level with Microsoft Visio
• Intermediate skill level in Microsoft Project, Word, and suite of Microsoft tools
• Intermediate skill level in Share Point Online, Microsoft Teams and Smart Sheet knowledge

Good-to-Have Skills:

• Prior experience as business analyst a plus.

Soft Skills:

• Exceptional communication skills – both written and verbal.
• Excellent active listening skills.
• Excellent analytical and abstraction reasoning skills, as well as problem solving ability
• Ability to effectively prioritize and execute tasks while under pressure.
• Able to work effectively at all levels in an organization.
• Must be a team player and able to work with and through others.
• Be a self starter, independent, resourceful. Able to exercise independent judgment and take action on it.

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