QA Technical Specialist

QA Technical Specialist

The AIN QA Technical Specialist plays a critical role in advancing Quality Assurance initiatives across the Quality Operations Network, with a particular focus on Management Review, Inspections and Compliance, and Technical Writing & Data Analytics. This role provides operational support, technical leadership, and cross-functional collaboration to ensure compliance, continuous improvement, and data-driven decision making in support of the Quality Management System (QMS). The position will be responsible for tasks including the key responsibilities documented below and other technical quality-related job functions.

This candidate will primarily work during regular working hours (9 AM – 6 PM local time) to enable the business in delivering Amgen's mission to serve patients and may lead a shift-based team that provides coverage in support 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 globally.

Key Responsibilities -

Management Review

• Coordinate and manage all logistics related to Site Management Review, including compiling metrics, maintaining and updating Smartsheet trackers, and preparing content.
• Perform site-level and cross-site trend analysis (as applicable) using key quality metrics; identify trends and collaborate with site stakeholders to implement corrective and preventive actions (CAPA).
• Lead preparation of Management Review meetings, ensuring comprehensive data presentation creation, documentation of meeting minutes, and follow-up on action items.

Inspections and Compliance

• Support readiness and response for internal and external inspections, including generation of pre-inspection documents such as deviation lists, change controls, and supporting evidence.
• Actively contribute during inspections by managing information requests, facilitating document electronic retrieval, and preparing responses in collaboration with subject matter experts.
• Lead Site Master File updates by coordinating content input from cross-functional stakeholders, drafting revisions, and managing review and approval workflows.

Technical Writing and Data Analytics

• Lead authoring and workflow coordination for periodic quality trend reports and related documentation.
• Generate deviation summary reports to support product and process monitoring efforts, ensuring accuracy and consistency with cGMP standards.
• Drive quality risk assessments, providing technical leadership in risk identification, analysis, and mitigation planning in alignment with standards.

Preferred Qualifications

• Demonstrated experience in a GMP-compliant environment with working knowledge of inspection protocols, site audits, and quality risk management principles.
• Proficiency in technical writing and data visualization tools; experience with Smartsheet, Tableau, or equivalent platforms preferred.
• Strong analytical skills with the ability to interpret data trends and drive improvements based on quality insights.
• Familiarity with electronic quality systems (e.g., Veeva, TrackWise, SAP-QM, LIMS) and documentation practices.
• Excellent verbal and written communication skills, including experience presenting to senior leaders.
• Proven ability to lead and collaborate within cross-functional teams in a dynamic, fast-paced setting.

Core Competencies

• Leadership in Quality Governance (e.g., Management Review)
• Inspection Readiness and Compliance Assurance
• Quality Data Visualization, Interpretation and Analytics
• Technical Document Drafting and Workflow Ownership
• Cross-Functional Stakeholder Engagement
• Continuous Improvement Mindset

Basic Qualifications and Experience:

• Master's degree with 5-9 years of Pharma and Biotech commercial or clinical manufacturing Quality experience.