Senior Quality Assurance Analyst – Aseptic Manufacturing

Aché Laboratórios

. Manage and execute validations related to aseptic processes .

Posted 10/15/2026full-timeCabo de Santo Agostinho • BrazilSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Aseptic Process Validation and compliance with Good Manufacturing Practices (GMP). Capable of managing validation protocols, leading investigations, and providing training to ensure process integrity and quality.

Highest-signal resume keywords

Aseptic Process ValidationSterilizing Filtration ValidationRadiation Sterilization Process ValidationGood Manufacturing Practices (GMP)Change Control Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Validation Protocol PreparationValidation Report ReviewProcess MonitoringNonconformance InvestigationCleaning Validation KnowledgeHolding Time Validation Knowledge

Soft Skills

CollaborationTraining CoordinationEffective Communication

Industry Keywords

Regulatory ComplianceValidation PracticesInternal AuditsQuality Assurance

About the role

Key responsibilities & impact

Manage and execute validations related to aseptic processes
Prepare and review validation protocols, reports, matrices, and plans
Monitor processes
Ensure compliance with established schedules
Coordinate and deliver training related to validation practices
Lead investigations into Nonconformances (RNCs)
Manage the initiation and analysis of change controls, ensuring compliance with internal and regulatory requirements
Represent the Validation function during internal and external audits
Maintain direct and effective collaboration with various areas of the organization to ensure process integrity and quality
Provide support to mid-level and junior analysts, as well as interns

Requirements

What you’ll need

Completed bachelor’s degree
Knowledge of Good Manufacturing Practices (GMP), legislation, standards, and guidelines related to aseptic processes
Experience in aseptic process validation
Experience in sterilizing filtration validation
Experience in radiation sterilization process validation
Knowledge of cleaning validation processes is a plus
Knowledge of Holding Time validation processes is a plus

Benefits

Comp & perks

Medical and dental insurance
Aché and Biosintética medications at no cost for you and your eligible dependents
Preventive screenings with no copayment
On-site medical appointments and diagnostic sample collection, depending on the facility
Wellhub (formerly Gympass)
“Estar Bem Aché” integrated health program
Support programs for pregnant employees and spouses, including postpartum support
Partnerships and agreements offering scholarships and educational discounts at various institutions
Profit-Sharing Program (PPR)
Private pension plan with a 1:1 employer match
On-site restaurant and meal voucher
Transportation allowance, parking, or company shuttle, depending on the facility
Childcare allowance or exclusive on-site daycare at the Guarulhos facility
Christmas gift