Sr Associate IS Bus Sys Analyst

Amgen - Holly Springs, NC

Full-time - Mid Level

Hybrid - Holly Springs, NC

Chemical Manufacturing

About the position

The Senior Associate Business Systems Analyst at Amgen will play a crucial role in supporting the Digital Technology & Innovation (DTI) team within the company's advanced drug substance manufacturing plant. This position focuses on optimizing processes, implementing automation, and ensuring compliance with regulatory standards. The analyst will engage with various stakeholders to analyze business needs, develop solutions, and maintain system integrity, all while contributing to Amgen's mission of serving patients with serious illnesses.

Responsibilities

• Support business and DTI partners to implement and support automation, infrastructure, business and platforms that achieve business objectives.
• Conduct process and computer systems analysis, requirements elicitation, and articulate system solutions for addressing business needs.
• Develop, test, and communicate business cases for proposed solutions, serving as the lead throughout and post-implementation.
• Support computerized system compliance initiatives and ensure adherence to Amgen corporate, GxP, and SOX compliance requirements.
• Engage with key vendors and platform owners to understand functionality and tackle compliance or business problems.
• Structure and standardize processes for scalability, efficiency, and growth across various platforms.
• Develop and maintain policies, standards, user guides, and guidelines across the platforms.
• Support release management and engagement of all platforms in the team, ensuring adherence to Amgen and regulatory standards.
• Provide guidance and set standards in producing quality documentation, serving as a liaison between DTI and Quality functions.
• Support Data Integrity efforts for automation, business, infrastructure, and analytical platforms.

Requirements

• Master's degree OR Bachelor's degree and 2 years of Information Systems experience OR Associate's degree and 6 years of Information Systems experience OR High school diploma / GED and 8 years of Information Systems experience.
• Strong customer service focus with the ability to develop and maintain effective working relationships.
• Demonstrated strong collaboration across all levels of the organization.
• Assertive and confident in raising action points with senior individuals with excellent spoken and written communication.
• 2+ years of experience supporting business process analysis with business owners and SMEs across multiple geographically dispersed teams.
• Experience performing and documenting business processes redesign and aligning business requirements to technical solutions.
• Strong verbal and presentation communication skills to engage with varying levels of audience both technical and non-technical.
• Experience writing and publishing internal white/position papers, user documentation, and SOPs.
• Domain knowledge of health care/life sciences is a plus.
• Strong Data Integrity experience applying to Business, Automation, and Analytical Systems.

Nice-to-haves

• Continuous improvement approach (i.e., LEAN, Kaizen, etc.).
• GxP experience and knowledge on regulations FDA Title 21 CFR Part 210 and 211.
• Knowledge of enterprise systems (e.g., Workday, Salesforce, Service Now, SAP).
• Ability to quickly assimilate knowledge of new platforms, languages, tools, and technologies.

Benefits

• Comprehensive employee benefits package including health and welfare plans.
• Retirement and Savings Plan with generous company contributions.
• Group medical, dental, and vision coverage.
• Life and disability insurance.
• Flexible spending accounts.
• Discretionary annual bonus program or sales-based incentive plan for field sales representatives.
• Stock-based long-term incentives.
• Award-winning time-off plans.
• Flexible work models, including remote and hybrid work arrangements.