Specialist Quality Assurance

Responsibilities
Manages the implementation of process changes and ensures consistent execution of the applicable quality processes in the site

Purposefully monitors execution of the specified quality processes and communicates performance to Global Process Owners/Users & Management

Understands process changes and communicates impact to management/users

Attends network/collaboration group meetings and represents site/functional challenges, lessons learned, audit and inspection findings and best practices

Reviews applicable Global Standard, and may author or QA process documentation or training materials

On-boards new users; provides training, facilitates learning groups and is a coach/mentor to users

Escalates performance issues and trends to the Global Process Owners, site management reviews, applicable SMEs and site/functional/regional management

Ensures inspection readiness and applicable local procedures are in alignment with quality process requirements and QMS architecture

Represents process during audits and regulatory agency inspections.

Engages with GPO when commitments are made after regulatory inspections

Develops and owns site/region specific commitments for process

Participates in process improvements initiated by the GPO/Network

May lead process improvements projects across the site/function/region.

May own site /function Deviations, CAPA/EVs, and change records for process

QA contact for site /function Deviations, CAPA/EVs and change control records

All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional tasks and responsibilities.

What we expect of you

Doctorate degree OR

Master’s degree and 2 years of directly related experience OR

Bachelor’s degree and 4 years of directly related experience OR

Diploma and 8 years of directly related experience

8 years related work experience (manufacturing, process development, or quality assurance) in the pharmaceutical / biologics industry with progressively increasing responsibility and demonstrated experience in project management, quality assurance, and quality systems.

Direct experience with bulk manufacturing of biopharmaceuticals/API preferred.

Demonstrated proficiency of written and verbal communication skills (including technical writing and presentations) with ability to communicate and collaborate effectively with technical and senior management staff.

Experience with regulatory audits and inspections

Problem solving skills with the ability to apply logic and assess data to reach decisions and solutions related to compliance and product quality.

Your selection for this role will be subject to fulfilling the medical requirements of this job scope. If so, you will be informed of the medical check(s) that you may need to undergo. All medical related expenses incurred from this medical check shall be borne by the company.

What you can expect of us

As we work to develop medicines for patients, we also invest in our people. Through competitive benefits, development opportunities, and a collaborative culture, we'll support your growth both professionally and personally.

Apply now and help transform the lives of patients while transforming your career.

careers.amgen.com

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 as we 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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