Specialist – Quality Control (Technical Resources)
Location: Hyderabad, India (On-Site)
Job Type: Full-Time
Job ID: R-231172
Experience Required: 6–12 years depending on educational background
Role Overview
Amgen India (AIN) is seeking a Specialist in Quality Control (Technical Resources) to join our global QC network. In this key role, you will manage the end-to-end lifecycle of controlled documents, supporting quality assurance and regulatory compliance across Amgen’s global operations. This position provides a unique opportunity to collaborate with QC teams worldwide, contributing to process harmonization, continuous improvement, and compliance in a highly regulated pharmaceutical environment.
This is a shift-based role with a hybrid element of remote support to Amgen sites across multiple time zones. The position is primarily based at Amgen India – Hyderabad.
Key Responsibilities
Manage global QC document requests, including intake, prioritization, and tracking to ensure timely completion.
Create, author, revise, and coordinate workflows for controlled documents across QC functions, ensuring compliance with cGMP, safety, and regulatory standards.
Collect, organize, and analyze data from multiple systems (LIMS, electronic lab notebooks) to support document management and reporting.
Facilitate collaboration across QC networks and cross-functional teams for document updates, process alignment, and standardization.
Drive project deliverables with a focus on accuracy, quality, and timelines.
Identify and resolve document-related issues, maintaining operational continuity across sites.
Maintain compliance with training requirements and regulatory standards for all QC documentation activities.
Support continuous improvement initiatives to enhance document structure, formatting standards, and data retrieval practices across the QC network.
Required Qualifications & Experience
Bachelor’s degree with 8 years of related QC or technical document experience, or
Master’s degree with 6 years of experience, or
Doctorate with 2 years of experience in related scientific or quality fields.
Proven experience in Chemistry, Biochemistry, Cell Biology, Immunology, or Microbiology within a QC laboratory environment.
Strong technical writing skills within a highly regulated environment.
Knowledge of cGMP regulations, quality control practices, and laboratory standards.
Excellent written and verbal communication skills and ability to work in a matrix team environment.
Experience with laboratory computer systems and document management platforms.
Preferred Skills:
Exposure to Operational Excellence initiatives.
Understanding of QC processes for drug substance and drug product in clinical and commercial operations.
Innovative thinking and structured problem-solving abilities.
Ability to navigate ambiguity while maintaining focus on deliverables and compliance.
Why Join Amgen India
Amgen is a global biotechnology leader committed to delivering therapies that improve patient outcomes worldwide. By joining our QC Technical Resources team, you will gain exposure to global processes, diverse products, and regulatory standards, while contributing to continuous improvement and excellence in quality operations.
Apply now to be part of a team that drives quality, compliance, and innovation in pharmaceutical development.
Gujarat :
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