At Amgen, a biotechnology leader driven by our mission to serve patients, we are looking for a QA Technical Senior Associate. This role is central to ensuring compliance and operational efficiency within our Quality Operations Network. You will execute key documentation processes, coordinate systems, and provide project support from our Hyderabad office.
What You'll Do
- Manage requests for site licenses and regulatory memo reports.
- Draft and manage workflows for QA-owned procedures, including Standard Operating Procedures (SOPs) and Appendices (APPX).
- Conduct periodic document reviews and support authoring and workflow coordination.
- Provide document system support using tools like DocuSign and Kneat.
- Create and maintain Smartsheet trackers and dashboards for quality and business operations.
- Provide project coordination and administrative support for invoicing, expense reporting, audit logistics, and travel arrangements.
- May lead a shift-based team providing coverage to support the Amgen network across multiple time zones.
- Lead remote support from Amgen India (AIN) to Amgen sites globally.
What We're Looking For
- Master’s degree.
- 3-6 years of Pharma or Biotech commercial or clinical manufacturing Quality experience.
Nice to Have
- Experience in a GMP or regulated environment with exposure to quality documentation systems.
- Strong attention to detail with demonstrated capability in document drafting and editing.
- Proficiency in document and project management systems such as DocuSign, Kneat, and Smartsheet.
- Effective organizational and time management skills with ability to manage multiple priorities.
- Strong communication and interpersonal skills for cross-functional coordination.
- Ability to follow established procedures and work independently within defined parameters.
Technical Stack
- DocuSign
- Kneat
- Smartsheet
Team & Environment
You may lead a shift-based team and will support the broader Quality Operations Network, providing essential coverage and remote support to Amgen sites across multiple time zones.
Work Mode
This is an onsite position based in Hyderabad, India. You will work primarily during regular hours but must be prepared to work outside routine hours to support global business needs.
Amgen is an equal opportunity employer.
