Sr Associate QA

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.

Position Summary:

The AIN Sr Associate QA plays a critical role in supporting disposition related tasks across the Amgen Quality Operations Network. The Senior Associate QA will leverage industry, technical, and quality systems knowledge to provide support of business performance and GMP disposition supporting processes across the network. The position will be responsible for tasks including the key responsibilities documented below and other disposition related job functions.

This candidate will primarily work during regular working hours (9 am – 6 PM local time) to enable the business in delivering Amgen’s mission to serve patients and may lead a shift-based team that provides coverage in support of the Amgen network across multiple time zones. The candidate may need to work outside of his/her routine workday to support business needs and will be responsible for determining the same for their staff. The individual will be required to work from our office located in Hyderabad India (Amgen India-AIN). The candidate will also lead the remote support from AIN to Amgen sites across multiple time zones which will include the following locations: US - California, Puerto Rico, North Carolina, Ohio, Rhode Island, Ireland - Dun Laoghaire, and Singapore.

Key Responsibilities

Business Performance

• Facilitation of Amgen disposition network meeting including meeting planning, preparation, communication of meeting notes, and action item tracking.
• Create, maintain, and report monthly disposition metrics in support of all Amgen sites.
• Create and sustain a visualization tool that displays the progress of each disposition element required for the disposition of a material and product batch.
• Monitoring of material and product batches to confirm readiness for disposition. Communicate to plants/sites when there is a material or product batch priority.

Technical Writing and Document Management

• Maintenance, periodic review, and revision of GMP procedures supporting global and site level disposition processes.
• Generate Production and Disposition summary to support the Annual Product Review (APR). Perform data verification, review/approval.

Quality Systems and Clinical Disposition Process Support

• Management and periodic review of badge access to controlled GMP areas.
• Periodic SAP security audits and access review for Amgen sites.
• Execution of GMP process for adding countries, branches, or studies to a clinical drug Product (FDP) batch in the ERP system as regulatory approvals are received.

Inspection Request Form (IRF) pre-request support

• Support readiness for internal and external audits and inspections including the provision of pre-inspection request documents such as disposition document lists and disposition lot lists.
• Support of information requests and response preparation during audits and inspections execution through the provision of disposition related information and data.

Preferred Qualifications

• Experience in project management and related systems
• Proficiency in technical writing and data visualization tools; experience with Smartsheet, Tableau, or equivalent platforms preferred.
• Strong analytical skills with the ability to interpret data and draw conclusions
• Excellent verbal and written communication skills
• Proven ability to lead and collaborate within cross-functional teams in a dynamic, fast-paced setting.

Core Competencies

• Organizational Agility
• Business Operations and Project Support
• Experience working in a regulated environment with knowledge of Good Manufacturing Practice (GMP) and Good Documentation Practice (GDP) requirements.
• Experience working with Quality Systems that may include enterprise resource planning (ERP/SAP), regulatory information management (RIM), controlled document management (CDOCs), change control (CCMS), deviation, and/or quality control laboratory information management systems (LIMS).
• Technical Document Drafting and Workflow Ownership
• Data Visualization, Interpretation and Analytics

Basic Qualifications and Experience:

• Master’s degree with 5-8 years of Pharma and Biotech commercial or clinical manufacturing Quality experience.