Associate Systems Analyst – Lab Informatics Systems (Quality Control IT)
Location: Hyderabad, India
Company: Amgen
Job ID: R-236626
Work Type: On-Site
Category: Information Systems / Lab Informatics
Experience Required: 2–4 Years (Bachelor’s) or 1–3 Years (Master’s)
Education: Bachelor’s or Master’s Degree in Computer Science, Information Technology, or Related Field
About the Company
Amgen is a global biotechnology leader focused on discovering, developing, manufacturing, and delivering innovative medicines for patients worldwide. With expertise across Oncology, Inflammation, General Medicine, and Rare Diseases, the organization leverages science and technology to address complex healthcare challenges while maintaining the highest standards of ethics and compliance.
Job Overview
The Associate Systems Analyst – Lab Informatics Systems will support the validation, implementation, maintenance, and optimization of Quality Control (QC) laboratory systems. This role is critical to ensuring system reliability, regulatory compliance, data integrity, and audit readiness within a GxP-regulated pharmaceutical environment.
The selected candidate will collaborate with product managers, validation teams, QC subject matter experts, and global IT stakeholders to deliver scalable, compliant, and high-performance lab informatics solutions.
Key Responsibilities
Support and maintain QC applications including configuration updates and system enhancements.
Ensure compliance with Computer System Validation (CSV) and Computer Software Assurance (CSA) frameworks.
Assist in validation deliverables including risk assessments, traceability matrices, test scripts, and IQ/OQ/PQ documentation.
Maintain audit-ready documentation including functional specifications, validation evidence, and SOPs.
Collaborate with cross-functional teams to translate business requirements into technical solutions.
Contribute to testing, debugging, and issue resolution for QC systems.
Perform system administration activities including access management, periodic reviews, change control documentation, and incident resolution.
Support data integrity controls aligned with 21 CFR Part 11 and global regulatory requirements.
Stay updated on emerging technologies, cloud platforms, and automation practices relevant to laboratory informatics.
Core Technical Skills (Must-Have)
Strong understanding of software development lifecycle and database concepts.
Experience with Quality Control platforms such as SampleManager LIMS, Electronic Lab Notebook (ELN), and Empower CDS.
Foundational knowledge of GxP regulations, CSV/CSA principles, and risk-based validation testing.
Hands-on experience with databases such as Oracle and MySQL.
Understanding of validation testing methodologies and compliance frameworks.
Preferred Skills
Knowledge of QC laboratory processes and data integrity best practices.
Exposure to AWS services such as EC2, S3, DynamoDB.
Experience with SQL, API integrations, and middleware tools such as Mulesoft.
Familiarity with remote access management platforms such as Citrix Workspace.
Strong technical documentation and stakeholder communication capabilities.
Professional Competencies
Strong analytical and problem-solving skills
Effective written and verbal communication
Ability to work in global, cross-functional environments
High level of initiative and accountability
Adaptability in regulated and fast-evolving IT landscapes
Experience Level Clarification
Bachelor’s Degree with 2–4 years of relevant experience in Lab Informatics, IT systems support, or regulated pharmaceutical environments
OR
Master’s Degree with 1–3 years of relevant experience
Experience in pharmaceutical, biotechnology, life sciences, or GxP-regulated industries is strongly preferred.
Why This Role Matters
This position directly supports laboratory digital transformation, regulatory compliance, and quality system reliability within a leading global biotechnology organization. Professionals seeking careers in Lab Informatics, QC IT Systems, Computer System Validation, and Pharmaceutical Digital Compliance will find this role aligned with long-term growth in life sciences technology.
Equal Opportunity Statement
Amgen is an Equal Opportunity Employer committed to diversity, inclusion, and fair hiring practices. Reasonable accommodations are available for qualified individuals during the recruitment and employment process.
SEO Keywords:
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