Quality Assurance Analyst (Mid-Level)

This is a fully remote position, open to applicants in Brazil.

📋 Description

• Implement, sustain, and enhance the Quality Management System (QMS) processes at the Linhares location

• Draft, assess, and authorize SOPs, work instructions, forms, plans, reports, and other quality documentation

• Oversee document and record control, ensuring version management, distribution, traceability, retention, archiving, and regular reviews

• Lead investigations into deviations and nonconformities by utilizing root-cause analysis tools

• Manage corrective and preventive actions (CAPA), including monitoring plans, deadlines, evidence, and effectiveness

• Direct the Change Control process and coordinate impact assessments

• Engage in quality risk management initiatives

• Organize and oversee training related to Good Manufacturing Practices (GMP) and the QMS

• Plan, execute, or participate in internal, supplier, and customer audits

• Prepare areas and documentation for health authority inspections and external audits

• Conduct and supervise the qualification and oversight of critical suppliers and service providers

• Monitor quality complaints and aid in investigations and corrective actions

• Prepare and evaluate QMS performance indicators, spotting trends, risks, and opportunities for improvement

• Assist in validation and qualification programs from a Quality Assurance viewpoint

• Advocate for Good Documentation Practices and data integrity

• Offer guidance to Junior Analysts, Inspectors, and other departments on QMS and GMP standards

• Collaborate with Production, Quality Control, Logistics, Maintenance, Engineering, and other departments to address quality-related challenges

• Suggest and implement enhancements while staying informed of legislation and standards relevant to cosmetic manufacturing

⛳️ Requirements

• Bachelor’s degree in Pharmacy, Chemistry, Chemical Engineering, Production Engineering, Biomedical Sciences, or a related discipline

• Experience in Quality Assurance or Quality Management Systems, ideally within the cosmetics, pharmaceutical, medical device, food, or chemical sectors

• Understanding of Good Manufacturing Practices (GMP) pertinent to the cosmetics industry

• Familiarity with Quality Management Systems and document and record management

• Insight into deviation management, nonconformities, CAPA, and Change Control processes

• Proficiency in investigation and root-cause analysis methodologies, including the 5 Whys, Ishikawa diagrams, and risk analysis techniques

• Awareness of internal audits, supplier qualification, and action plan follow-up procedures

• Knowledge of Good Documentation Practices and principles of data integrity

• Comprehension of quality indicators and trend analysis

• Proficient in Microsoft Office, particularly Word, Excel, and PowerPoint

• Preferred: experience in the cosmetics, pharmaceutical, or food sectors along with QMS implementation or development

• Preferred: understanding of Brazilian regulations RDC No. 48/2013, ISO 22716, and other regulatory requirements relevant to the cosmetics industry

• Preferred: experience with regulatory, customer, and/or supplier audits

• Preferred: knowledge of validation, equipment qualification, cleaning validation, and process validation

• Preferred: familiarity with electronic quality management systems, ERP, or SAP

• Preferred: intermediate proficiency in English

🏝️ Benefits

• Employment under Brazil’s CLT labor regime

• Remote work as specified in the job posting header