Senior Associate Quality Assurance
Location: India - Hyderabad
Work Location Type: On Site
Date Posted: Feb. 01, 2025
Category: Quality
Join Amgen’s Mission of Serving Patients
At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.
Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas – Oncology, Inflammation, General Medicine, and Rare Disease – we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller, happier lives.
Our award-winning culture is collaborative, innovative, and science-based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Senior Associate Quality Assurance:
What You Will Do:
In this vital role, you will be serving patients through internal collaboration with Amgen’s global quality teams, manufacturing sites, and external engagement with contract manufacturing organizations. You will make key contributions to ensure high-quality and right-first-time materials are received at Amgen, build a resilient supply network, and conclude with a positive patient experience.
In this role, you will be part of Amgen’s Global Supply Quality team, supporting oversight and maintenance of contract manufacturers.
Roles & Responsibilities:
Enter analytical data into LIMS.
Create and update LIMS sample plans.
Generate Certificate of Analysis.
Compile batch release documentation.
Perform QA Approver role on Quality Events.
Initiate Quality records for supplier-related changes.
Prepare, review, and approve SOPs and other GMP/GDP documentation in compliance with corporate and regulatory requirements to ensure alignment with procedures, current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP), and other applicable regulations.
Take part in operational and quality improvement initiatives, programs, and projects.
Communicate effectively with stakeholders, ensuring alignment on quality objectives and compliance needs.
This role may require working in shifts or extended hours within the same shift to support global time zones.
What We Expect of You:
We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a detail-oriented, collaborative individual with the following qualifications:
Basic Qualifications:
Master’s degree and 1 to 3 years of professional experience in related fields OR
Bachelor’s degree and 3 to 5 years of professional experience in related fields OR
Diploma and 7 to 9 years of professional experience in related fields
Understanding of GMP/GDP requirements
Familiarity with raw material compendial testing
Experience overseeing the quality of suppliers or external parties
Strong technical writing skills
Preferred Qualifications:
Experience and strong familiarity with digital tools and computerized systems.
Strong continuous improvement attitude and lean practices experience.
Understanding of end-to-end supply chain business processes.
Experience in project management across multiple departments and geographies.
Quick process understanding, insight, and visualization.
Strong analytical and problem-solving skills.
Independent self-starter, able to work autonomously, under pressure, and in teams.
GMP/GDP knowledge and understanding of pharmaceutical regulations.
Energetic, detail-oriented, highly motivated with a “can-do” outlook.
Change management skills.
Ability to communicate across all levels of the organization.
Effective written and verbal communication skills.
Experience with Microsoft Office Tools including Excel, Word, and PowerPoint.
Ability to multi-task and prioritize.
Soft Skills:
Excellent analytical and troubleshooting skills.
Strong verbal and written communication skills.
Ability to work effectively with global, virtual teams.
What You Can Expect of Us:
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
Apply now for a career that defies imagination.
Objects in your future are closer than they appear. Join us.
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