Surgery Commercial Quality Analyst

Biopharma Asia; Bogotá; On-site; COP 60,000,000 - 95,000,000; Full time

Job summary

Johnson & Johnson in Bogotá seeks a Surgery Commercial Quality Analyst to join the Business Quality Team. The role ensures compliance with the Quality Management System, supports investigations of non-conformances, and manages training and document control.

Responsibilities include Change Control, Technovigilance, product discontinuation, and collaboration with manufacturing for local reconditioning. English proficiency and a science-related degree are required.

Qualifications

• Minimum 2 years of work experience in Quality Systems (GMP) preferably in medical devices.
• A bachelor’s degree is required. A degree in science, engineering, chemistry, pharmacist, administration or related field is preferred.
• English (min B1).
• Operation of Microsoft Office.
• Knowledge on SAP and Excel is desirable.
• Quality System courses are desirable.

Responsibilities

• Ensure compliance with company policies, procedures, and quality standards.
• Supports the implementation of applicable requirements to the Quality System, such as requirements from the MT Segment, global, regional or local requirements.
• Support investigations of non-conformances and definition of preventive and corrective actions through the analysis of root causes and participate in meetings with the other areas involved.
• Manage the training process, ensuring compliance with the metric defined for timelines and completion and complying with the minimum requirements established in the Curriculum Matrix.
• Support the document control and records management processes, ensuring compliance with the company procedures.
• Change Control execution process support, ensuring that the changes are evaluated, registered, reviewed, and approved prior to implementation.
• Technovigilance Surveillance Responsible: Manage and report to health authorities serious and non-serious adverse events related to medical devices, as provided in resolution 4816 of 2008.
• Responsible for local product discontinuation and NPI (New product introduction) processes and evaluation of Local Opportunity Products (POLO)
• Interaction with manufacturing plants to manage local reconditioning in compliance with the company's Repack & Relabel requirements.
• Document Non-Conformities in the DES (Designated Electronic System); ensuring compliance with the different stages: identification, investigation, cause analysis, correction, implementation of corrective and preventive actions and verification of effectiveness.
• Deployment of recall, stop shipment and sanitary alerts processes as required by Quality Management.
• Perform handling material data transactions in SAP (Master Data).
• Responsible for the shipment to the operating company of product complaint samples.
• Support other responsibilities according to the backup system established, in case that is required, the Commercial Quality Supervisor or Specialist will support the activities described in this job description.
• Ensures compliance with the Good Practices and EHS Regulations among other policies and guidelines of the company.

Skills

Strong written and verbal comms

Teamwork & collaboration

Planning & organization

English proficiency

MS Office proficiency

SAP knowledge

Education

Bachelor's degree in science/engineering/chemistry/pharmacist/administration

Tools

SAP

Excel

Job description

Job Function

Quality

Job Sub Function

Customer/Commercial Quality

Job Category

Professional

All Job Posting Locations

Bogotá, Distrito Capital, Colombia

Job Description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/ .

Johnson & Johnson is currently seeking a Surgery Commercial Quality Analyst to join our Business Quality Team located in Bogotá.

Overall purpose of job

Ensure compliance with policies and procedures described in the Quality Management System applicable to the Companiesmentionedin the MT LATAM Quality Manual, distribution channels and requirements indicated by Local Quality Regulations. Establishes and maintains quality assurance programs, procedures and controls, ensuring that performance parameters of both the products and quality system elements are continually measured to drive improvement initiatives. Ensure compliance for training and qualification program, records management and document control, change control process and samples management for human and non-human use. Ensure compliance with policies and procedures described in the MT LATAM Quality Manual applicable to the role and requirements indicated by Local Quality Regulations.

Essential duties and responsibilities

According to the Business requirements and leading strategy the main activities of this role can be some of the above:

Ensure compliance with company policies, procedures, and quality standards.

Supports the implementation of applicable requirements to the Quality System, such as requirements from the MT Segment, global, regional or local requirements.

Support investigations of non-conformances and definition of preventive and corrective actions through the analysis of root causes and participate in meetings with the other areas involved.

Manage the training process, ensuring compliance with the metric defined for timelines and completion and complying with the minimum requirements established in the Curriculum Matrix.

Support the document control and records management processes, ensuring compliance with the company procedures.

Change Control execution process support, ensuring that the changes are evaluated, registered, reviewed, and approved prior to implementation.

Technovigilance Surveillance Responsible: Manage and report to health authorities serious and non-serious adverse events related to medical devices, as provided in resolution 4816 of 2008.

Responsible for local product discontinuation and NPI (New product introduction) processes and evaluation of Local Opportunity Products (POLO)

Interaction with manufacturing plants to manage local reconditioning in compliance with the company's Repack & Relabel requirements.

Document Non-Conformities in the DES (Designated Electronic System); ensuring compliance with the different stages: identification, investigation, cause analysis, correction, implementation of corrective and preventive actions and verification of effectiveness.

Deployment of recall, stop shipment and sanitary alerts processes as required by Quality Management.

Perform handling material data transactions in SAP (Master Data).

Responsible for the shipment to the operating company of product complaint samples.

Support other responsibilities according to the backup system established, in case that is required, the Commercial Quality Supervisor or Specialist will support the activities described in this job description.

Ensures compliance with the Good Practices and EHS Regulations among other policies and guidelines of the company.

Job Requirements

Essential knowledge and skills

1. Minimum 2 years of work experience is required in Quality Systems (Good Manufacturing Practices) preferably in medical devices companies.

2. A bachelor's degree is required. A degree in science, engineering, chemistry, pharmacist, administration or related field is preferred.

3. English (min B1).

4. Operation of Microsoft Office.

5. Knowledge on SAP and excel is desirable

6. Quality System courses are desirable

Core competencies required for this role

Strong written and verbal communication skills

Management of complexity

Planning and organization skills.

Effective and assertive communication skills - Written and verbal.

Skills for prioritization of activities and sense of urgency.

Strong teamwork and connect skills

Good communication skills in English and Spanish

Results oriented

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.

Required Skills

Preferred Skills

AI Judgement Integration, Business Behavior, Compliance Management, Continuous Improvement, Data Analysis, Data Compilation, Detail-Oriented, Execution Focus, Goal Attainment, Internal Controls, Issue Escalation, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Report Writing