Commercial Quality Analyst

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.

We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.

At Johnson & Johnson, we all belong

We are searching for the best talent for Commercial Quality Analyst (9 Months) to be in Embu das Artes, São Paulo, Brazil
- Purpose:
Performs and maintains quality assurance programs, supplier systems, procedures and controls, ensuring that performance parameters of both the products and quality system elements are continually measured to drive improvement initiatives. Provides support for quality projects. Ensures and maintains a state of inspection readiness to Johnson & Johnson Vision business.

You will be responsible for:

- Complies with company policies, procedures, and quality standards, as well as safety and environmental regulations.
- Develops solutions basic scope and intermediate complexity.
- Assists in writing standard operating procedures. Performs and provides support for the product review and release functions.
- Identifies significant trends. Generates statistical summaries. Participates in quality system improvement initiatives.
- Assists in the documentation of corrective action plans and monitors implementation and follows up on closure of corrective and preventive actions.
- Coordinates the impact assessment of the regulatory requirements applicable to Distribution Center, when defined by the Commercial Quality Leader.
- Support internal and external quality audits (Corporate J&J, VISA, CRF/CRQ related, INMETRO, etc.)
- Supports internal/external and suppliers audit activities, responses, and compliance with due dates.
- Ensures the updating and maintenance of the regulatory documentation related to the regulatory agency related to the website under his responsibility.
- Monitors trends, identifies issues, recommends and implements appropriate actions.
- Assists in the development, implementation and review of standard operating procedures for interactions with 3PL (Distribution Center) as J&J oversight.
- Acts as Technical responsible for Distribution Center.
- Ensures the updating and maintenance of the regulatory documentation related to the regulatory agency related to the site under his responsibility.

Assists in the development, implementation and review of standard operating procedures for interactions with 3PL (Distribution Center).

This role reports directly to the Commercial Quality Operations Sr. Supervisor.

**Qualifications**:

- University degree in pharmacy, chemical engineering, life-science or health-related discipline.
- Acts as Technical responsible for Distribution Center.
- 2-4 years’ experience in quality role: pharmaceutical, medical devices or related experience.
- Intermediate English required.
- Management of the documentation of the quality system according to ISO 13485 and GMP standards. Comprehensive knowledge in regulatory affairs, regulations, GMP legislation and general product.
- Analytical profile with strong verbal and written communication skills; high personal accountability, proactive and problem-solving skills.
- Accountability to work with a medium level of supervision; strong team player with initiative who collaborates well with internal / external partners.
- Practical mastery of quality tools (5 whys, Ishikawa, 5S, PDCA).
- Lead auditor certification - ISO 13485 will be a nice to have
- Experience to receive audits with regulatory agencies (CRF-SP/CRQ-SP related, ANVISA, VISA, INMETRO).
- Previous experience in a Quality / Regulatory Role is essential.