Specialist Quality Assurance - Amgen

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.

Quality Assurance Specialist

What you will do

Lets do this! Lets change the world!

The Quality Management Systems (QMS) Specialist supports operations at the Amgen, Thousand Oaks site by providing site level oversight for one or more Quality Processes. The oversight will include SME level guidance for process end users, performance monitoring and management of the process(es) at the site level, end user voice of customer engagement, as well as interaction with the Corporate Quality Global Process Owner (GPO) to recommend process improvements and to facilitate global alignment and improvement implementations. The QMS Specialist may support one or more of the following processes depending on fit and experience, Document Management, Recalls, Disposition, Inspection Readiness, Learning & Performance, Risk Management, Management Review, Equipment Qualification, Calibration and Maintenance, and various Process Development processes.

Responsibilities:

• Ensure QMS processes are appropriately designed, implemented and managed across the ATO site to ensure they are fit for purpose for effective phase appropriate practices in Process Development, Clinical and Commercial functions.

• Ensure appropriate escalation of key QMS risks and accomplishments to senior management, through Management Review.

• Actively participate and provide leadership on Amgens global QMS networks, learning from peer sites and influencing Amgens overall QMS strategy.

• Translate external regulations into understandable and implementable processes at ATO

• Based on execution performance, propose and implement Continuous Improvement and Productivity initiatives, programs and projects.

• Represent Quality on cross functional teams in the execution of projects necessary to achieve departmental operational excellence goals and will work in a team matrix environment.

• Review and approve controlled documents, including Standard Operating Procedures, and reports

• Participate in Amgen internal/external audits and inspections, potentially interacting directly with regulatory and/or third party auditors.

• Author and own (potentially) cGMP documents and reports

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications.

Basic Qualifications:

• Doctorate degree OR

• Masters degree and 2 years of quality systems experience OR

• Bachelors degree and 4 years of quality systems experience OR

• Associates degree and 8 years of quality systems experience OR

• High school diploma / GED and 10 years of quality systems experience

Preferred Qualifications:

• Highly effective verbal and written communication skills with strong interpersonal skills

• Strong level of analytical skills to evaluate and interpret information to arrive at logical and quality-minded conclusions balanced with a willingness to take informed and appropriate risks.

• Extensive knowledge of Quality Assurance functions and practices across a broad range of manufacturing and supply chain processes

• Strong leadership capabilities and proven experience applying GMP requirements in an operational setting

• Ability to effectively present information to all levels of the organization with appropriate messaging and effective focus on desired outcomes.

• Demonstrated ability with project management, initiating and leading cross-functional teams, leading and managing change

• Previous experience with quality system transactions (SAP, LIMS, Trackwise, Veeva)

• Proficiency with database use, including data input, archival, and query retrieval

• Direct experience driving process improvements. Working knowledge of Lean and Six Sigma methodologies a plus

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.

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.

careers.amgen.com

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.