Quality Assurance Specialist

538 Marken Brasil Servicos de Cadeia de Suprimentos Ltda; São Paulo; On-site; BRL 90,000 - 140,000; Full time

Job summary

538 Marken Brasil Servicos de Cadeia de Suprimentos Ltda seeks a Quality Assurance Specialist to support the QA Supervisor in maintaining Marken's Quality Management System and regulatory compliance. You will ensure adherence to GMP, GDP, and GSP across storage, distribution, and transportation operations.

Responsibilities include auditing, CAPA development, training coordination, and readiness for client and regulatory inspections. Strong English and MS Office skills are required.

Qualifications

• Pharmaceutical or healthcare industry experience required.
• Bachelor’s Degree in Science-related field or equivalent.
• Knowledge of GMP, GDP, GSP guidelines.
• Knowledge of local regulations.
• Experience with Quality Management Systems and CAPA.
• Strong written and verbal communication skills.
• Excellent interpersonal skills and teamwork.
• Proficient with Microsoft Office.
• Advanced English communication.

Responsibilities

• Assist QA Supervisor with oversight and implementation of QMS, SOPs and policies.
• Interact with clients on QA/GxP matters.
• Oversee internal audit schedule and CAPA tracking and follow-up.
• Audit external service providers as part of vendor selection.
• Coordinate CAPA plans and close-out actions.
• Ensure training and regulatory updates are reflected in SOPs.

Skills

Quality management awareness

Written and verbal communication

Interpersonal skills

Organized and methodical

Attention to detail

English communication

Education

Bachelor’s Degree in Science related field

Tools

Microsoft Office

Job description

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Job Description

Job Summary

The Quality Assurance Specialist is responsible for supporting the QA Supervisor with the oversight and implementation of the Marken Quality Management System (QMS), Standard Operating Procedures (SOPs), processes and policies required to manage and control Marken’s Storage, Distribution and Transportation, Kit Production Facility. The QAS also needs to ensure compliance with applicable regional and local regulations and requirements, and customer requirements as appropriate, but not limited to: current Good Manufacturing Practice (GMP), Good Distribution Practices (GDP), Good Storage Practices (GSP), ISO 13485 and ISO 9001.

Responsibilities

Implement, communicate and maintain the company’s quality systems at the facility, in compliance with Marken’s Global Quality Management System (QMS) requirements. Interact with clients on Quality Assurance (QA)/ GxP related matters. Effectively interact with Departments and stakeholders to maintain that all QA tasks are appropriately supported by QA. Oversee an internal audit schedule and perform internal audits including report preparation and assessment and tracking of associated corrective and preventive actions (CAPA). Perform audits of external service providers as part of the vendor selection process. Tracking and overseeing all commitments for actions or changes made from previous audits. Support client audits and regulatory inspections, including and preparing appropriate materials required within those audits when applicable. Support the audit report responses and act as main representative when aligned with QA Supervisor. Work and manage issues and CAPA plans, collate CAPA metrics, and identify and implement quality improvement initiatives. Oversee activities that conclude on the appropriate close-out of all CAPA entries. Identify relevant GxP/ Quality related training needs and deliver or ensure they will be delivered when required. Support on change control management. Ensuring that the Quality System and GxP Program are implemented and maintained. Assisting in the evaluation of designated vendors and/or out-sourced activities. Ensuring the accuracy and quality of records and documents. Monitor that training for all personnel is conducted and documented. Coordinating and promptly performing any recall activity. Participate actively in all the internal Quality and/ or designated meetings. Keep informed of regulatory changes in Country/Region and prompt updates to SOPs as needed. To execute qualification activities and oversee calibration related to devices, equipment, systems and facility in SAO branches. Ensure that the facility is working according to local laws and authority regulations.

Qualifications

Pharmaceutical or healthcare industry experience; Bachelor’s Degree in Science related field (or internationally comparable degree) required; Knowledge of Good Manufacturing Practice, Good Sorage Practice and Good Distribution Practice guidelines; Knowledge of local regulations; Previous experience in Quality Management Systems with an eye for details; Excellent written and oral communication skills; Good interpersonal skills; Organized, methodical and efficient approach to work; Proficient use of Microsoft office; Advanced English communication; Employee Type: Permanent UPS is committed to providing a workplace free of discrimination, harassment, and retaliation. In 1907, two teenage entrepreneurs in a Seattle basement started with a $100 loan and created what would become the world’s largest package delivery service. Today, operating in more than 220 countries and territories, UPS is committed to moving our world forward by delivering what matters. UPS and its more than 500,000 UPSers around the globe are a transportation and logistics leader, offering innovative solutions to customers, big and small. UPS understands and appreciates its responsibility to help build safe, stronger and more resilient communities founded on justice and economic opportunity for all, supported by a healthy, sustainable global environment.