Associate Quality Compliance

4 days ago

Hyderabad, Telangana, India Amgen Full time

Role Name: Associate Quality Compliance

Department Name: R&D Quality

Role GCF: 3

ABOUT AMGEN

Amgen harnesses the best of biology and technology to fight the world's toughest diseases, and make people's lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what's known today.

ABOUT THE ROLE

Role Description:

The Controlled Documentation Associate plays a critical role in supporting Amgen's R&D Quality Management System through the execution and maintenance of controlled document workflows. This role ensures that R&D controlled documents, such as SOPs and work instructions, are developed, maintained, and retired in compliance with global standards and GCP regulations. The associate will collaborate across functions to facilitate document approval processes, conduct quality checks, and support inspection readiness activities.

Roles & Responsibilities:

  • Execute and track workflows for creation, revision, and obsoletion of documents with the controlled document management system (CDOCS).
  • Perform controlled document impact analysis in support of business requests and initiatives.
  • Maintain document metadata in CDOCS.
  • Conduct quality checks, editing, and proofreading of documents for consistency and compliance.
  • Monitor document workflows, notify stakeholders of pending tasks, and follow up to ensure timely completion.
  • Support inspections and audits by retrieving and compiling requested documents.

Basic Qualifications and Experience:

  • Masters Degree in Sciences or related field with 2-6 years exp in Pharmaceutical/Biotechnology/Clinical research

Functional Skills:

Must-Have Skills:

  • Strong attention to detail with proven ability to perform quality reviews.
  • Working knowledge of document control tools and best practices.
  • Excellent verbal and written communication skills.
  • Ability to manage document workflows and prioritize tasks.

Good-to-Have Skills:

  • Experience working in a multinational environment with global teams.
  • Experience using CDOCS or equivalent electronic document management system.

Soft Skills:

  • Strong problem-solving abilities and adaptability to changing priorities.
  • Strong attention to detail and accuracy.
  • Excellent organization and coordination skills.
  • Clear and concise communication abilities.
  • Team-oriented and proactive approach.

EQUAL OPPORTUNITY STATEMENT

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

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