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QA Technical Senior Associate - Remote

Posted 2 days ago
QA
Full Time
India

Overview

The QA Technical Senior Associate supports Quality Assurance initiatives across the Quality Operations Network with a primary focus on Technical Writing, Document Management, and Business Performance. This role is responsible for executing key QA documentation processes, system coordination, and project-related administrative functions to ensure compliance with Quality Management System (QMS) expectations and operational efficiency.

In Short

  • Support Quality Assurance initiatives across the Quality Operations Network.
  • Focus on Technical Writing, Document Management, and Business Performance.
  • Execute key QA documentation processes and system coordination.
  • Manage requests for site licenses and regulatory memo requests.
  • Draft and manage workflows for QA-owned procedures.
  • Conduct periodic document reviews and support authoring.
  • Create and maintain Smartsheet trackers and dashboards.
  • Provide project coordination and administrative support.
  • Work from the office in Hyderabad, India, with remote support globally.
  • Lead a shift-based team providing coverage across multiple time zones.

Requirements

  • Master’s degree with 3-6 years of Pharma and Biotech Quality experience.
  • Experience in a GMP or regulated environment.
  • Strong attention to detail in document drafting and editing.
  • Proficiency in document and project management systems.
  • Effective organizational and time management skills.
  • Strong communication and interpersonal skills.
  • Ability to follow established procedures independently.

Benefits

  • Opportunity to work with a leading biotechnology company.
  • Engage in initiatives that improve health outcomes.
  • Collaborate with cross-functional teams.
  • Potential for career growth in a dynamic environment.
  • Access to advanced tools and technologies in the industry.
Amgen logo

Amgen

1074 Amgen Technology Pvt Ltd. is a leading biotechnology company dedicated to improving the quality of life for patients suffering from serious illnesses. Since its inception in 1980, Amgen has pioneered advancements in biotech, focusing on four key therapeutic areas: Oncology, Inflammation, General Medicine, and Rare Disease. The company is committed to discovering, developing, manufacturing, and delivering innovative human therapeutics, leveraging advanced human genetics to address complex diseases. With a collaborative and science-based culture, Amgen strives to make a lasting impact on patients' lives while fostering an inclusive environment for its diverse workforce. As a global leader in biotechnology, Amgen continues to develop a pipeline of medicines aimed at addressing high unmet medical needs and improving health outcomes worldwide.

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