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Specialist Quality Control

3 weeks ago

Hyderabad, Telangana, India Amgen Full time

Role Description:

In this vital role, you will be part of Amgen India's (AIN) Quality Control (QC) Technical Resources team, supporting Amgen's global Quality Control network. The QC Technical Resources team will provide centralized document management expertise across global QC functions, ensuring the efficient, compliant, and consistent management of controlled documents within Amgen's enterprise document management system. As a QC Specialist, you will be responsible for end-to-end document lifecycle management, including document creation, authorship, review, and revision, for a range of QC processes. These include, but are not limited to, general laboratory practices related to Cell Biology, Chemistry, Microbiology, Biochemistry, and Immunology, laboratory consumables and equipment management, and periodic trend assessments. This position offers a unique opportunity to collaborate with QC teams across Amgen sites worldwide, contributing to process harmonization and continuous improvement. You will gain broad exposure to Amgen's diverse product portfolio and processes throughout the product lifecycle.

This candidate will primarily work a shift-based schedule to enable the business in delivering Amgen's mission to serve patients. The candidate may need to work outside of his/her routine workday to support business needs. The individual will be required to work from our office located in Hyderabad, India (Amgen India-AIN), and provide remote support from AIN to Amgen sites across multiple time zones globally.

Roles & Responsibilities:

  • Managing document requests from the global QC Network, including intake, prioritization, and tracking to completion.
  • Creating, authoring, revising, and coordinating workflows for a variety of controlled document types, ensuring completion within agreed timelines and in compliance with procedural requirements.
  • Collecting, organizing, and analyzing data from multiple repositories (e.g., LIMS, electronic laboratory notebooks) to support document management activities.
  • Facilitating information gathering and alignment across the QC Network and cross-functional partners to support document updates and process harmonization.
  • Driving project deliverables to ensure timely and high-quality completion of assigned tasks and initiatives.
  • Supporting issue identification and resolution, collaborating effectively across sites and functions to maintain operational continuity.
  • Ensuring all controlled documents meet Amgen's quality standards and comply with cGMP, safety, and other applicable regulatory requirements.
  • Ensuring all assigned training requirements are completed, current, and compliant with cGMP standards.
  • Identifying opportunities for continuous improvement to ensure alignment in document structure, formatting standards, and data retrieval/compilation practices across the network.

Basic Qualifications and Experience:

  • Industry related experience related to one or more of the following: Chemistry, Biochemistry, Cell Biology, Immunology, Microbiology
  • Quality Control laboratory experience
  • High school diploma / GED and 12 years of related experience OR
  • Associate's degree and 10 years of related experience OR
  • Bachelor's degree and 8 years of related experience OR
  • Master's degree and 6 years of related experience OR
  • Doctorate degree and 2 years of related experience

Functional Skills:

Must-Have Skills:

  • Strong technical writing skills within a highly regulated environment
  • Working knowledge of cGMP regulations, practices, and trends pertaining to Quality Control
  • Excellent written and verbal communication skills, ability to work in a team matrix environment and build relationships with partners
  • Experience with various laboratory computer systems and applications

Good-to-Have Skills:

  • Demonstrated innovative thinking and ability to transform work processes
  • Exposure to Operational Excellence initiatives
  • Understanding of Quality Control processes related to drug substance and drug product for clinical and commercial operations
  • Demonstrated ability to navigate through ambiguity and provide structured problem solving