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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
Amgen

Join Amgen’s Mission of Serving Patients
At Amgen, we are united by a shared mission—to serve patients living with serious illnesses. Since 1980, we have pioneered biotechnology to tackle the world’s toughest diseases. Our focus on Oncology, Inflammation, General Medicine, and Rare Disease has allowed us to reach millions of patients annually. As part of the Amgen team, you’ll have a lasting impact on patients' lives by helping to research, manufacture, and deliver innovative medicines that promote longer, fuller, and happier lives.

At Amgen, our culture is collaborative, innovative, and science-driven. If you are passionate about challenges and seeking growth opportunities, you will thrive with us. Join us and transform the lives of patients while transforming your career.


What You Will Do
In this critical role, you will be responsible for managing complex and innovative projects, including the strategic planning, development, and execution of Software Development Lifecycle deliverables. You will engage in all phases of computerized systems validation/assurance, from planning and requirements to testing (e.g., IQ, OQ) and final approval of documentation. You will also provide expert guidance and collaborate across teams to meet organizational goals.


Responsibilities

  • Quality Assurance Ownership: Take responsibility for evaluating validation and qualification packages, ensuring completeness and accuracy in line with regulatory expectations.
  • Compliance & Data Analysis: Conduct thorough data analysis, ensuring compliance with validation policies and procedures while raising critical issues to management as needed.
  • Change Control & Documentation: Initiate, review, and approve Change Controls, deviations, and problem records in systems like TrackWise/Veeva, ServiceNow. Oversee validation documentation and standard operating procedures (SOPs).
  • Regulatory & Continuous Improvement: Support regulatory inspections, engage in Continuous Improvement activities, and collaborate in management reviews and training initiatives.
  • Audit Support & System Assessments: Participate in system periodic reviews, support supplier evaluations, and engage in the Integrated Systems Assessment (ISA) process.

What We Expect of You

Basic Qualifications:

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

Preferred Qualifications:

  • Demonstrated experience in Computer System Validation and Quality Assurance in a regulated industry (preferably Biotechnology or Pharmaceuticals)
  • Strong understanding of GxP regulations, including GMP, GLP, GCP, GPvP, and GDP standards
  • Expertise in information systems such as LIMS, CDOCS, SAP, and Maximo
  • Problem-solving and decision-making skills, capable of resolving complex issues
  • Independent work style with the ability to lead projects or teams effectively

What You Can Expect of Us
At Amgen, we believe in supporting your professional and personal growth. We offer a competitive salary and comprehensive Total Rewards Plans that align with industry standards. Our collaborative culture will help you succeed as you contribute to our mission and your own career growth.