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Senior Associate Quality Control Support - Stability - Remote

Posted 1 week ago
QA
Full Time
USA
81,082.00 - 98,151.00 USD/year

Overview

The Senior Associate Quality Control Support - Stability role at Amgen involves supporting the site Stability team QC startup and operations, contributing to the mission of serving patients through innovative biotechnological solutions.

In Short

  • Support startup of the QC organization and Stability Program.
  • Write procedures and reports for stability-related activities.
  • Manage clinical and commercial stability products.
  • Ensure compliance with cGMP regulations.
  • Participate in audits and interdepartmental projects.
  • May require travel for method or knowledge transfers.
  • Work collaboratively with site teams.
  • Maintain sample integrity for stability studies.
  • Support routine activities on weekends and public holidays.
  • Act as the site subject matter expert for the Stability program.

Requirements

  • High School/GED + 4 years of Quality work experience, or Associate’s + 2 years, or Bachelor’s + 6 months, or Master's.
  • Degree in a related scientific field preferred.
  • 3-5 years of relevant laboratory experience in GMP manufacturing.
  • Solid understanding of aseptic technique.
  • Proficient in Veeva and Trackwise systems.
  • Experience in a lead role guiding team members.
  • Strong written and verbal communication skills.
  • Familiar with change control records.
  • Experience with equipment and method validation.
  • Ability to work effectively in teams.

Benefits

  • Competitive salary and comprehensive Total Rewards Plans.
  • Support for professional and personal growth.
  • Collaborative and innovative work culture.
  • Opportunities to make a lasting impact on patients' lives.
  • Inclusive environment respecting diversity and ethics.
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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