Qa Engineer Product Tester

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

**Before you apply to a job, select your language preference from the options available at the top right of this page.**
Explore your next opportunity at a Fortune Global 500 organization. Envision innovative possibilities, experience our rewarding culture, and work with talented teams that help you become better every day. We know what it takes to lead UPS into tomorrow-people with a unique combination of skill + passion. If you have the qualities and drive to lead yourself or teams, there are roles ready to cultivate your skills and take you to the next level.
**Job Description:**
The Global Systems & Standards Senior communicates the quality policy and objectives to help ensure the maintenance of the overall healthcare compliance for the operation/department. The employee will advise on development of standard operating procedures (SOPs), reviews and approves client and facility work instructions, trains QA personnel and internal clients on SOPs and regulatory topics, and oversees the maintenance of the quality documents. This position participates in internal, client, and agency audits, and follows up on audit outcomes. The HC Quality Assurance Supervisor maintains knowledge of healthcare quality and regulatory requirements: and assesses and addresses risks associated with transporting healthcare and food products.
Responsibilities:
Monitors and instructs for compliance to UPS SCS site license requirements (DEL, MDEL, CDS, PCR).
Promotes Issue resolution, risk management, continuous improvements and project initiatives.
Facilitates, hosts, and respond to audits (Internal, Regulatory Agencies and Clients)
Assists with creation, revision, and approval of Controlled Documents (SOP/WI/Forms).
Provides investigation and Non-conformance reporting, including development of proactive strategies for preventing recurrence.
Changes control management.
Provides Quality and Regulatory compliance guidance to clients and internal staff.
Supports growth of new and expanded facilities, clients and services.
Participates in environmental control and CDS security emergency response action team.
Performs direct reports responsibilities (risk assessment, task delegation, performance evaluation, skills development, constructive feedback, formal performance review, formal career development)
Qualifications:
Bachelor's degree or International equivalent in Sciences- Required
Pharmaceutical, healthcare or food industry experience - Preferred
Quality Assurance experience - Preferred
QPIC/AQPIC designation - Preferred
**Employee Type:**
Permanent
UPS is committed to providing a workplace free of discrimination, harassment, and retaliation.

**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 shared mission-to serve patients living with serious illnesses-drives all that we do.
Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning