Specialist Business Analyst

Role Description:

In this vital role, you will be part of the Quality Control (QC) Products Team, collaborating closely with business partners, product owners, analysts, developers, and testers to ensure that validation activities and strategies for IT systems are executed effectively and in compliance with organizational and regulatory requirements.

This position plays a key role in driving compliance, efficiency, and innovation in the management of data validation processes that support the QC product lifecycle. You will help advance continuous improvement and automation initiatives across the QC digital ecosystem, ensuring systems and tools are optimized to meet evolving quality standards.

Roles & Responsibilities:

• Act as a liaison between Quality Control (QC), IT, vendors, and developers to capture, document, and translate business requirements into system solutions.
• Support multiple QC digital platforms including Thermo Fisher Sample Manager LIMS, Biovia OneLab ELN, Waters Empower CDS, and other QC applications.

• Elicit, analyze, and document user requirements to ensure solutions meet laboratory business needs, regulatory requirements (GxP, 21 CFR Part 11), and Amgen standards.

• Collaborate with developers and system owners to configure, integrate, and validate QC systems, ensuring alignment with Amgen's system lifecycle management framework.

• Lead and participate in system validation activities, including authoring/reviewing protocols (IQ, OQ, PQ), test scripts, and maintaining traceability across requirements.
  Ensure system integrations between QC platforms (LIMS ELN CDS- Data Lakes, ERP, or reporting systems) are reliable, compliant, and support end-to-end workflows.
• Contribute to Agile delivery by participating in backlog refinement, sprint planning, and retrospectives, ensuring user stories are well-defined and testable.
• Monitor and report on system performance, usage, and validation status, generating dashboards and insights to support QC leadership.
• Champion digital transformation in QC labs, identifying opportunities for automation, efficiency, and enhanced data integrity.
• Stay current on QC informatics trends (LIMS, ELN, CDS, regulatory updates) and recommend improvements or upgrades.

Basic Qualifications and Experience:

• Master's degree with years of experience in Computer Science, Business, Engineering, IT or related field OR
• Bachelor's degree with years of experience in Computer Science, Business, Engineering, IT or related field

Functional Skills:

Must-Have Skills:

• Strong understanding of Quality Control platforms and business process
• 6-8 years of Global Pharmaceutical industry experience
• Strong understanding of pharmaceutical clinical operation and data management business processes
• Experienced in pharmaceutical regulations and specifications
• Proven ability to manage medium to large-scale projects in a regulated (GxP) environment, ensuring successful delivery across multiple stakeholders and systems.
• Strong project management skills with experience using methodologies such as Agile, Waterfall, or hybrid approaches.
• Solid understanding of GxP regulations, specifically 21 CFR Part 11.
• Expertise in defining and implementing validation strategies aligned with regulatory requirements.
• Demonstrated ability to balance competing priorities while maintaining compliance, quality, and delivery standards.
• Excellent communication skills and the ability to collaborate with senior leadership with confidence and clarity.

Good-to-Have Skills:

• Proficiency in automation tools and validation software.
• Experience of DevOps, Continuous Integration, and Continuous Delivery methodologies.
• Experience as a business analyst, with command of business analysis techniques & tools, as well as SDLC & iterative systems development methodologies (Scrum Agile, etc.).

Professional Certifications:

• SAFe – DevOps Practitioner (preferred)
• SAFe for teams (preferred)

Soft Skills:

• Able to work under minimal supervision.
• Skilled in providing oversight and mentoring team members. Demonstrated ability in effectively delegating work.
• Excellent analytical and gap/fit assessment skills.
• Strong verbal and written communication skills.
• Ability to work effectively with global, virtual teams.
• High degree of initiative and self-motivation.
• Ability to manage multiple priorities successfully.
• Team-oriented, with a focus on achieving team goals.
• Strong presentation and public speaking skills.

Shift Information:

This position requires you to work a later shift and may be assigned a second or third shift schedule. Candidates must be willing and able to work during evening or night shifts, as required based on business requirements.