Specialist Quality Assurance

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Specialist Quality Assurance

What you will do

Let's do this. Let's change the world. In this vital role you will be responsible for sophisticated or innovative projects involving strategic planning, development and execution of Software Development Lifecycle deliverables. The candidate will be involved in all phases of computerized systems validation/assurance; planning, requirements, testing (e.g. IQ, OQ), and approval of documentation supporting the process. The candidate will offer guidance, technical information and work optimally in a collaborative environment to meet organization goals.

Responsibilities

Take ownership and accountability as a Quality Assurance for records/tasks assigned. Evaluate validation and qualification packages of computerized systems to ensure they are complete, accurate, and meet regulatory expectations. Ensure compliance with validation policies and procedures and conduct thorough data analysis to compare results against acceptance criteria. Collaborate with various organizations to resolve challenges/issues, raise critical issues to management's attention.

• Initiate, Review and Approve Change Controls as QA contact (e.g. TrackWise/Veeva, ServiceNow)

• Initiate, Review and Approve deviations (Minor & Major)

• Review and Approve problem records in ServiceNow

• Serve as Owner or QA contact for CAPA and Efficiency Verification (EV) records

• Review and Approve Validation documentation

• Review and Approve operational, administrative SOPs and Work Instructions

• Review and Approve Data Integrity Assessments (DIA)

• Review and Approve System Periodic Review & Audit Trail

• Supports Continuous improvement activities and initiatives

• Supports Training initiatives and strategy as needed

• Supports the Management Review Process as needed

• Supports the Integrated Systems Assessment (ISA) Process as needed

• Supports Supplier Evaluations as needed

• Participate in and support regulatory inspections as needed

What we expect of you

We are all different, yet we all use our unique contributions to serve patients.

Basic Qualifications:

Master's degree and 4 to 6 years of technical field experience OR

Bachelor's degree and 6 to 8 years of technical field experience OR

Diploma and 10 to 12 years of technical field experience

Preferred Qualifications:

• Work Experience: 3- 5 demonstrated ability in Computer System Validation, Quality Assurance processes in a regulated industry (preferred Biotechnology/Pharmaceutical)

• Demonstrated experience in the validation of computerized systems

• Demonstrated experience in handling quality assurance processes

• Regulatory experience: Ability to interpret and apply GxP regulations, including GMP, GLP, GCP, GPvP, and GDP standards

• Technical experience: Extensive technical knowledge of Information Systems such as LIMS, CDOCS, SAP, and Maximo.

• Problem-Solving: Strong analytical and problem-solving skills, capable of addressing and resolving sophisticated quality issues using multiple sources of information (e.g., Qualitative information, Quantitative research, Trend data)

• Strong decision-making skills and can handle and drive tasks to completion

• Independent and can work with minimal day to day supervision

• Leadership: Can lead a project, assigned tasks or group of individuals as required

What you can expect of us

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

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Apply now

for a career that defies creativity

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

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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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