Associate QC

4 weeks ago

Hyderabad, India Amgen Full time

Associate QC – QC Systems Templating

Role Name: Associate QC

Department Name: Quality Control

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:

Let's change the world. Amgen is hiring for an Associate to 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 the creation, revision and qualification of templates for analytical method executions in ELN. Creation and revision of consumable templates will also be in the scope of responsibility.

The Associate will ensure assigned tasks are carried out according to the correct procedures, best practices, and service level agreements for QC standardization. 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 with schedule.

To effectively provide support, candidates must demonstrate proficiency in virtual communication tools and have experience interacting in remote collaborations.

The following are some examples of tasks for the position

  • Creation and revision of ELN templates

  • Qualification of ELN templates

  • Creation and revision of consumable templates

  • Understand and follow established instructions to complete assigned deliverables within expectations

  • Collaboration with AIN team members to support the QC network needs

  • Ensuring training is up to date

Additional responsibilities may involve:

  • Assistance in providing performance metrics

Basic Qualifications and Experience:

  • Master's degree with 1-3 years of Pharma and Biotech commercial or clinical manufacturing Quality Control experience.

Functional Skills:

  • QC lab testing experience

  • Exposure to ELN applications

  • Microsoft Office proficiency

  • Familiarity with Good Manufacturing Practices and Good Documentation Practices

Soft Skills:

  • Excellent English verbal and written communication skills

  • Ability to learn quickly with attention to detail

  • Delivering results right first time within a team environment

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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