Sr Associate QC

Sr Associate QC – QC Systems Templating

Role Name: Sr Associate QC

Department Name: Quality Control

Role GCF: 4

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:

Let’s change the world. Amgen is hiring fora Senior Associateto support the Electronic Lab Notebook (ELN) and consumable inventory system infrastructure in the Quality Control (QC) network. 

This candidate will primarily work a shift-based schedule to enable the business in delivering Amgen’s mission to serve patients. The candidate may need to work outside of his/her routine workday to support business needs. The individual will be required to work from our office located in Hyderabad India (Amgen India-AIN), and provide remote support from AIN to Amgen sites across multiple time zones globally.

Roles & Responsibilities:

This position will be responsible for creating, revising, peer-reviewing and qualifying templates for analytical method executions in ELNwhich includes ELN interfaces with other systems such as LIMS, Empower, and Chromeleon. Creation and revision of consumable templates, and supplementary master data will also be in the scope of responsibility.

In addition, this position will collaborate with the US-based Master Data Group (MDG) and will also be involved in ELN template administration/registration activities, ensuring tasks align with procedures, best practices, and service level agreements for QC standardization. Coordination with site representatives and other ELN template builders and qualifiers is required to convert QC source documents into ELN templates accurately. Coordination with members within the team at AIN on the same shift and members of the team at AIN on different shifts will be critical in ensuring deliverables are met in accordance withschedule. 

To effectively provide support, candidates must demonstrateproficiency in virtual communication tools and have experience managing remote collaborations. Secondary responsibilities may include cross-training into LIMS, Empower, andChromeleon. 

The following are some examples of tasks for the position

• Creation and revision of ELN templates

• Peer reviewing templates built by colleagues

• Qualification of ELN templates

• Creation and revision of consumable templates

• Collaboration with method subject matter experts, template builders and template qualifiers throughout the QC network

• Ensuring training is up to date

Additional responsibilitiesmay involve:

• Providing performance metrics

• Driving global QC system alignment

• Understanding prioritization of requests with the QC network

Basic Qualifications and Experience:

• Any degree with 5-8 years of Pharma and Biotech commercial or clinical manufacturing Quality Control experience 

Functional Skills:

• QC lab testing experience

• Proficiency in ELN applications

• Knowledge of Data Integrity Requirements for QC systems

• Microsoft Office proficiency

• Familiarity with Good Manufacturing Practices

Soft Skills:

• Excellent English verbal and written communication skills

• Problem-solving and troubleshooting abilities

• Independence in delivering right first time