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Specialist Quality Assurance

2+ years
Not Disclosed
10 Nov. 26, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Specialist Quality Assurance at Amgen

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our mission to serve patients living with serious illnesses drives everything we do. Since 1980, Amgen has been at the forefront of biotech innovation, pioneering new treatments for the world’s most challenging diseases. Focusing on Oncology, Inflammation, General Medicine, and Rare Diseases, we reach millions of patients each year. As a member of the Amgen team, you’ll play a key role in researching, developing, and delivering life-changing medicines that help people live longer and healthier lives.

Our award-winning culture is based on collaboration, innovation, and science. If you’re passionate about challenges and eager to seize opportunities, you’ll thrive at Amgen. Join us to transform both the lives of patients and your career.


What You Will Do

As a Specialist in Quality Assurance, you will be responsible for managing complex projects that involve strategic planning, development, and execution of Software Development Lifecycle deliverables. You will engage in all stages of computerized systems validation/assurance, including planning, requirements, testing (e.g., IQ, OQ), and documentation approval. You will provide technical guidance and work collaboratively to meet organizational goals.


Responsibilities

  • Quality Assurance Ownership: Take responsibility for assigned records and tasks. Evaluate computerized systems' validation and qualification packages to ensure they are complete, accurate, and comply with regulatory standards.
  • Compliance & Data Analysis: Ensure adherence to validation policies, procedures, and data analysis, comparing results against acceptance criteria. Collaborate with teams to resolve issues and escalate critical matters to management.
  • Change Control & Documentation: Review and approve Change Controls, deviations, and problem records via TrackWise/Veeva and ServiceNow. Oversee validation documentation, SOPs, and work instructions.
  • Regulatory & Continuous Improvement: Assist in regulatory inspections, support Continuous Improvement activities, and contribute to management reviews and training initiatives.
  • System Assessments & Audit Support: Review system periodic reports, support supplier evaluations, and participate in the Integrated Systems Assessment (ISA) process.

What We Expect of You

Basic Qualifications:

  • Master’s degree with 4 to 6 years of technical experience OR
  • Bachelor’s degree with 6 to 8 years of technical experience OR
  • Diploma with 10 to 12 years of technical experience

Preferred Qualifications:

  • 3-5 years of demonstrated experience in Computer System Validation and Quality Assurance in regulated industries (preferably Biotechnology/Pharmaceutical)
  • In-depth understanding of GxP regulations, including GMP, GLP, GCP, GPvP, and GDP
  • Expertise with systems such as LIMS, CDOCS, SAP, and Maximo
  • Strong problem-solving skills with the ability to resolve complex quality issues using qualitative, quantitative, and trend data
  • Independent, self-driven with leadership experience in managing projects or teams
  • Excellent decision-making skills and task completion ability

What You Can Expect of Us

At Amgen, we are committed to your professional and personal growth. In addition to a competitive base salary, we offer comprehensive Total Rewards Plans that are aligned with industry standards. Our collaborative and supportive culture will help you succeed as you contribute to our mission and grow in your career.


Apply Now

If you’re ready to make a difference in the world of healthcare, [Apply Now] to join Amgen.


Amgen is an Equal Opportunity Employer

Amgen fosters a diverse, inclusive environment and will consider all qualified applicants regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability status, or any other basis protected by applicable law. We ensure individuals with disabilities receive reasonable accommodations to participate in the job application or interview process and perform essential job functions. Please contact us for accommodation requests.