Quality Assurance Analyst II
Share
Job Location:
Monthly Salary:
Posted on:
17 hours ago
Vacancies:
1 Vacancy
Job Summary
At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at
Job Function:
QualityJob Sub Function:
Customer/Commercial QualityJob Category:
ProfessionalAll Job Posting Locations:
Lima PeruJob Description:
Johnson & Johnson is currently seeking a Commercial Quality Analyst to join our Commercial Quality Med Tech team located in Lima Peru (on-site at the warehouse).
At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere 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 Summary:
Support activities related to implementing maintaining and improving the Quality Management System to comply with current local legislation the Quality Manual and global quality standards. Ensure the quality system is properly maintained by managing and monitoring processes required for continuous improvement in accordance with J&J policies (CAPA Events/Deviations/Complaints Change Control Escalations and others). Guarantee compliance with J&J Quality policies and local regulations within the Distribution Center.
Key Responsibilities:
- Prepare and update procedures work instructions and documents applicable to the quality system according to local regulatory requirements and corporate policies.
- Create manage and monitor records in the quality system (Non-conformities Corrective and Preventive Actions Change Control) consolidating evidence of action plan execution.
- Perform product inspection and disposition according to local regulatory requirements and company parameters.
- Execute and deploy field actions.
- Monitor the quality system through routine KPI evaluations generating reports for QSMR and other governance scenarios.
- Support processes related to repackaging and relabeling requirements.
- Assist with product discontinuation activities.
- Manage quality records at the local warehouse.
- Review and approve materials for local repackaging ensuring compliance with Health Authority approvals.
- Support supplier management including qualification (audits) monitoring and disengagement.
- Conduct training on company procedures for the storage service provider.
- Ensure compliance with J&J Quality policies and local regulations within the Distribution Center.
- Act as Assistant Technical Director.
Requirements:
- Licensed Pharmaceutical Chemist (Pharmacist) with active professional registration and good standing in Peru
- 3 years of experience in Quality Assurance within the pharmaceutical or medical device industry preferred.
- Knowledge of local regulations and Quality Management Systems.
- Intermediate English proficiency.
- Availability Monday to Friday 48 hours per week.
- The position involves moderate physical effort and requires standing for several hours during the workday
Core Competencies:
- Attention to detail and regulatory compliance.
- Strategic thinking and analytical skills.
- Effective communication and collaboration.
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 worlds 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:
Required Experience:
IC
Key Skills
- Test Cases
- SQL
- Quality Assurance
- Agile
- TFS
- Jira
- Software Testing
- Test Automation
- Cucumber
- QA/QC
- SDLC
- Selenium
About Company
About Johnson & Johnson A t Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s larges ... View more
