QA Technical Senior Associate

Amgen Inc.

3.6

(9)

Hyderabad, India

Why you should apply for a job to Amgen Inc.:

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Flexible work models that empower staff members to work where and when they are most productive

Award-winning PTO plan and bi-annual company-wide shutdowns

With 11 Employee Resource Groups, 60 chapters & 11000 members everyone has opportunity to connect, network & foster a culture of belonging

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Position summary

ort of the Amgen network across multiple time zones. The candidate may need to work outside of his/her routine workday to support business needs and will be responsible for determining the same for their staff. The individual will be required to work from our office located in Hyderabad India (Amgen India-AIN). The candidate will also lead the remote support from AIN to Amgen sites across multiple time zones globally.

Key Responsibilities

Technical Writing and Document Management

Manage requests for site licenses and country-specific reports, such as regulatory memo requests.
Draft and manage workflows for QA-owned procedures, including Standard Operating Procedures (SOPs) and Appendices (APPX).
Conduct periodic document reviews and support authoring and workflow coordination as required.
Provide document system support using tools such as DocuSign and Kneat.

Business Performance

Create and maintain Smartsheet trackers and dashboards to support quality and business operations.
Provide project coordination and administrative support for activities including invoicing, expense reporting, audit logistics, poster/presentation compilation, and travel arrangements.

Preferred Qualifications

Experience in a GMP or regulated environment with exposure to quality documentation systems and tools.
Strong attention to detail with demonstrated capability in document drafting and editing.
Proficiency in document and project management systems such as DocuSign, Kneat, and Smartsheet.
Effective organizational and time management skills with ability to manage multiple priorities.
Strong communication and interpersonal skills for cross-functional coordination.
Ability to follow established procedures and work independently within defined parameters.

Core Competencies

Technical Writing and Document Control
System and Workflow Coordination
Business Operations and Project Support
Cross-Functional Communication and Collaboration
Organizational Agility
Detail-Oriented Execution

Basic Qualifications and Experience

Master's degree with 3-6 years of Pharma and Biotech commercial or clinical manufacturing Quality experience.