Senior Specialist Quality - Global Network QC Digital Optimization Business Process Owner

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Job description

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds 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, youll 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, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Senior Specialist Quality - Global Network QC Digital Optimization Business Process Owner

What you will do

Lets do this! Lets change the world! Sr. Specialist of Quality is responsible for the maintenance, development, and implementation of the LIMS and Empower computer relates systems used with Amgen Quality Control. The candidate must ensure all relevant quality and regulatory requirements are met for these systems and ensures site compliance with quality system regulations issued by the FDA, MHRA, and other applicable regulatory bodies where Amgen clinical or commercial products are in use. Responsible for the evaluation and assurance that the appropriate procedures are in place to support LIMS/Empower. This position is responsible for the oversight of both LIMS and Empower from a day to day perspective as well as a forward looking strategic perspective. This role will report to the QC GNL.

Key responsibilities of this role include:

Technical Implementation-

• Manage and serve as a technical lead for ongoing QC digitalization and transformational efforts

• Leverage existing QC business knowledge, and identify and implement relevant data driven capabilities to enhance QC lab operations across the READ spectrum

• Maintain existing and design new network and site level reports within the QC domain capturing various quality and business metrics/KPIs

• Develop and deliver required data assets to QC clients as needed

• Translate complex problems and build relevant data-driven solutions to provide actionable insight to executives

• Work closely with other data scientists to develop production level code and deliver end-to-end digital solutions

• Create a self-service data query capability so that staff can support RFI during inspections

Data management-

• Develop a network level QC data governance strategy to ensure high quality and highly reliable data

• Drive standardization of existing QC data systems across the network and develop data lifecycle management strategies in collaboration with other team members

• Identify other reusable data assets being developed within operations and develop a strategy to demonstrate them within QC

Collaboration:

• Work closely with business owners, product managers, product owners, and agile team members, to prioritize, plan, and deliver on QC transformational business initiatives

• There is an expectation that this position will enable Reliability and Agility within the QC network while driving a 5% year over year improvement in productivity/efficiency

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Data Science professional we seek is a problem solver with these qualifications.

Basic Qualifications:

• Doctorate degree and 2 years of Data Science or Information Technology experience OR

• Masters degree and 4 years of Data Science or Information Technology experience OR

• Bachelors degree and 6 years Data Science or Information Technology experience OR

• Associates degree and 10 Data Science or Information Technology experience OR

• High school diploma / GED and 12 years of Data Science or Information Technology experience

Preferred Qualifications:

• 5+ year industry experience in quantitative analytics and applied data science

• Extensive knowledge of the QC data systems: LIMS, LMES, Maximo, SAP, Rapid Response, LMS, CDOC and SharePoint

• Experience with one or more programming/scripting languages python, SQL

• Experience in building ETL pipelines, specifically, writing complex SQL queries on very large data sets

• Excellent communicator able to write and speak about technical concepts to business, technical, and general audience

• Familiarity with distributed (Spark, Dask) and cloud (AWS, GCP) computing

• Familiarity with software engineering best practices including Git or similar version control tools

• Experience related to building and deploying modeling pipelines in reporting platforms

• Demonstrated skill at data visualization and building reports

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts

• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan

• Stock-based long-term incentives

• Award-winning time-off plans

• Flexible work models, including remote and hybrid work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided 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 accommodation.

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