QA Engineer – Healthcare Compliance & Audits

Arkem; Buenos Aires; On-site; ARS 136,254,000 - 196,812,000; Full time

Job summary

Amgen is seeking a Global Systems & StandardsSenior role focused on healthcare quality and regulatory compliance. The position involves guiding SOP development, reviewing client and facility work instructions, training QA staff on SOPs, and ensuring maintenance of quality documents.

Responsibilities include audits coordination, risk assessment, and ensuring adherence to healthcare quality standards. The role supports environmental control and CDS security readiness within the operation.

Qualifications

• Bachelor's degree or international equivalent in Sciences required.
• Quality Assurance experience preferred.
• QI/QA certification (QPIC/AQPIC) preferred.

Responsibilities

• Monitors and instructs for compliance to site license requirements (DEL, MDEL, CDS, PCR).
• Promotes issue resolution, risk management, continuous improvements and project initiatives.
• Facilitates audits (internal, regulatory agencies and clients) and responds to findings.
• Assists with creation, revision, and approval of controlled documents (SOP/WI/Forms).
• Provides investigation and non-conformance reporting with proactive recurrence prevention.

Skills

Quality Assurance experience

Audit readiness

Regulatory knowledge

Education

Bachelor's degree in Sciences

QPIC/AQPIC designation

ISO/GMP knowledge

Job description

Amgen is seeking a Global Systems & StandardsSenior role focused on healthcare quality and regulatory compliance. The position involves guiding SOP development, reviewing client and facility work instructions, training QA staff on SOPs, and ensuring maintenance of quality documents.

Responsibilities include audits coordination, risk assessment, and ensuring adherence to healthcare quality standards. The role supports environmental control and CDS security readiness within the operation.