Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.

Specialist Quality Assurance-AML Quality Systems Deviation SME

Live

What you will do

Let’s do this. Let’s change the world! In this vital role you will support the Deviation SME reports to the AML Quality Systems area within AML Quality Compliance and provides service to the AML site including DS, DP, and supporting areas. As Specialist QA you will bring forth out of the box thinking, an agile demeanor with a subject matter expertise and highly developed understanding of Quality processes and controls.

Specific responsibilities include but are not limited to:

• Designs innovative ways to drive continuous improvement and agility in the Deviation quality processes using Amgen approved platforms.
• Accountable for overall Deviation/Quality Systems platforms architecture, interfaces between systems, and user’s administration.
• Captures, collects, and reports Deviation quality process’ performance metrics and data requests.
• Owns and improves the Quality Systems Learning Center and the Error Prevention and Management Governance.
• Advances the use of system capability and features to drive business efficiencies and process optimization.
• Owns, coordinates, and maintains key visualization platforms supporting quality processes using MS Teams, Share Point, Spotfire, Smartsheet, etc.
• Leads continuous process improvements and partners with Quality Processes’ SMEs on key initiatives.
• Maintains positive relationship with other Quality functions to ensure feedback on existing process.
• Understands and identifies data trending and its impact to the Quality Processes.
• Follows up on actions to drive quality process’ continuous improvement and raises to management, as appropriate.
• Owns and manages Deviations, CAPAs and CAPA EVs.
• Partners cross functionally to ensure the Quality Management System processes are carried out in accordance with established procedures.
• Owns, drafts, and edits documents ensuring alignment with document hierarchy and document templates.
• Partners with the site Quality Systems team to ensure overall systems availability, reliability, and continuous improvement.
• Performs review, approval, and revision of quality processes procedures including but not limited to those related to Deviations and CAPAs.
• Actively engage in continues improvement initiatives, programs, and projects. Being also the continuous improvement champion.
• Vigilant ensuring that changes that could potentially impact product quality are assessed according to procedures.
• Certifies that deviations from established procedures are optimally investigated and documented.
• Partners cross functionally to ensure the Quality Management System processes are carried out in accordance with established procedures.
• Strategic advisor to senior management of quality and compliance risks.
• Supports internal/external audits and inspections as part of the audit/inspection management team including acting as Quality unit representative as needed.
• Supports regulatory inspections and audits.
• Acts as Back up to the CAPA SME with appropriate cross-training.
• Accountable for assigned training adherence to implement the appropriate tasks.
• Supports non-standard shift and extended hours including weekends, as per business needs.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients! The Specialist QA professional we seek is an Individual Contributor Leader with these qualifications.

Doctorate degree

Or

Master’s degree and 3 years of Quality and/or Manufacturing support GMP regulated environment experience

Or

Bachelor’s degree and 5 years of Quality and/or Manufacturing support GMP regulated environment experience

Or

Associate’s degree and 10 years of Quality and/or Manufacturing support GMP regulated environment experience

Or

High school diploma / GED and 12 years of Quality and/or Manufacturing support GMP regulated environment experience

Beyond that, additional preferred qualifications are:

• Knowledge and proficiency in data management platforms e.g. Spotfire, Data Bricks, Trackwise, etc.
• Understanding of quality processes including change control, deviation, CAPA, and risk assessment, etc.
• Experience in investigations and corrective and preventative actions
• Ability to work effectively in cross-functional teams
• Ability to translate strategic opportunities and emerging technology solutions into tangible executable plans
• Ability to influence the development of business strategy according to process requirements
• Independent, self-motivated, organized, able to multi-task in project environments
• Embraces a team-based culture that relies on collaboration for effective decision-making
• Strong problem solving, trouble shooting, and analytical skills
• Advanced technical writing skills
• Advanced data trending & evaluation knowledge and ability to evaluate compliance issues
• Constructively progress to outcomes despite uncertainty or ambiguity
• Motivate change, efficiency, and strong cross-functional relationships
• Ability to effectively negotiate and Influence at all levels of the organization
• Leadership skills and the ability to oversee multiple projects simultaneously
• Ability to discern user requirements for input to solutions development
• Able to successfully manage workload to achieve timelines
• Ability to negotiate a position after taking feedback from multiple sources
• Demonstrated ability to lead cross-functional teams and consistently deliver on-time with quality results
• Ability to operate in a team environment with site, functional, and executive leadership
• Experience driving decision making by using DAI principles
• Able to facilitate and influence stakeholders and partners
• Educational background in Life Science and/or Engineering.
• Experience in computer systems and quality assurance (technical proficiency).
• Strong organizational skills, including ability to follow assignments through to completion.
• Experience as Quality for complex projects
• Ability to interact with regulatory agencies.
• Proven word processing, presentation, database, and spreadsheet application skills.
• Strong communication (both written and oral), facilitation and presentation skills in English and Spanish.
• Strong communication (both written and oral), facilitation and presentation skills in English and Spanish.
• Skills working independently and to effectively interact with all levels throughout the organization.
• Sophisticated data trending & evaluation knowledge and ability to evaluate compliance issues.

Thrive

Some of the vast rewards of working here

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

• Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
• A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
• Generous Total Rewards Plan—comprising health, finance and wealth, work/life balance, and career benefits—with compensation and benefits rated above 4 stars (out of 5) on Glassdoor

Apply now

for a career that defies imagination

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

careers.amgen.com