Senior Quality Assurance Analyst

Posted 5 Days Ago
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Pindamonhangaba, São Paulo, BRA
In-Office
Senior level
Biotech • Pharmaceutical
The Role
Responsible for maintaining and improving the Quality Management System in compliance with ISO 9001, GMP, and applicable regulations. The role manages document and change control, audits, supplier qualification, complaints, deviations, nonconformities, CAPA, returned products, quality KPIs, training, and continuous improvement. It also supports regulatory compliance, risk mitigation, management reviews, and audit readiness across quality processes.
Summary Generated by Built In

It's fun to work in a company where people truly believe in what they are doing!

Responsible for executing, maintaining, and supporting the continuous improvement of the Quality Management System (QMS) in compliance with NBR ISO 9001 and applicable regulatory requirements. Works independently in document control, change control, nonconformity investigations, customer complaint handling, internal audits, and continuous improvement activities, contributing to process compliance, risk mitigation, and a strong quality culture.

Key Responsibilities

  • Execute, support, and drive the implementation, maintenance, and continuous improvement of the Quality Management System (QMS) in compliance with NBR ISO 9001 requirements.
  • Monitor organizational processes to ensure compliance with QMS requirements, Good Manufacturing Practices (GMP), and internal procedures.
  • Prepare, review, control, and maintain QMS documentation, ensuring proper traceability, version control, and record retention.
  • Support the onboarding and training of new employees regarding QMS requirements and the organization's quality culture.
  • Develop, monitor, and report quality performance indicators (KPIs), identifying trends, risks, and opportunities for improvement.
  • Deliver and support training related to ISO 9001, QMS procedures, and Good Manufacturing Practices.
  • Plan, conduct, and participate in internal audits in accordance with ISO 9001 and ISO 19011 guidelines, and support external audits.
  • Perform supplier audits to assess compliance with quality standards, regulatory requirements, and internal supplier qualification processes.
  • Manage the customer complaint process, ensuring proper documentation, root cause investigation, and implementation of corrective actions.
  • Execute and monitor change control activities, assessing risks and potential impacts on the Quality Management System.
  • Investigate process deviations, nonconformities, product issues, raw material concerns, packaging material issues, and operational deviations using quality management tools.
  • Define, monitor, and verify the effectiveness of corrective and preventive actions, ensuring timely closure.
  • Oversee the handling of customer-returned products from receipt through final disposition in accordance with internal procedures.
  • Ensure appropriate communication regarding waste management activities in compliance with QMS requirements and applicable regulations.
  • Support follow-up activities and action plans resulting from Management Review meetings, maintaining accurate records and meeting minutes.
  • Actively contribute to continuous improvement initiatives across the Quality Management System.
  • Perform other duties and responsibilities as assigned by the immediate supervisor.

Education, Experience, and Language Requirements

Education

Required:

  • Bachelor's degree in Chemistry, Chemical Engineering, Pharmacy, or a related field.

Preferred:

  • Postgraduate degree, specialization, or certification in Quality Management, Management Systems, or a related discipline.

Knowledge, Skills, and Qualifications

Required:

  • Proficiency in Microsoft Office and corporate digital tools.
  • Knowledge and interpretation of NBR ISO 9001 requirements.
  • Internal Auditor certification/training based on NBR ISO 19011.
  • Experience with quality tools applied to investigations of deviations, nonconformities, and corrective and preventive actions.

Preferred:

  • Validation and Qualification methodologies.
  • Risk and Opportunity Management.
  • Knowledge of regulatory requirements applicable to veterinary products (MAPA) and household/institutional pesticide products (ANVISA).

Experience

Required:

  • Previous experience working with Quality Management Systems (QMS).

Preferred:

  • Minimum of 3 years of experience in Quality Assurance, Quality Management Systems, or related areas.

Languages

Required:

  • Fluent Portuguese.
  • Intermediate English.

Preferred:

  • Advanced English.
  • Intermediate Spanish.

Behavioral Competencies

  • Strong attention to detail and commitment to quality.
  • Analytical thinking and problem-solving skills.
  • Excellent organizational and prioritization abilities.
  • Effective communication and training facilitation skills.
  • Teamwork and cross-functional collaboration.
  • Proactive mindset with a focus on continuous improvement.
  • Ability to work independently and manage multiple priorities in a dynamic environment.

Come Be Part Of A Mission that Matters!

From inside the farm gate to our dinner plates, Neogen protects the world’s food supply. Through a variety of animal healthcare products, to food safety solutions for dangerous bacteria, allergens, toxins, drug residues and much more, Neogen is there — and you can be too.

Skills Required

  • Bachelor's degree in Chemistry, Chemical Engineering, Pharmacy, or a related field
  • Proficiency in Microsoft Office and corporate digital tools
  • Knowledge and interpretation of NBR ISO 9001 requirements
  • Internal Auditor certification or training based on NBR ISO 19011
  • Experience with quality tools for investigating deviations, nonconformities, and corrective and preventive actions
  • Previous experience working with Quality Management Systems
  • Fluent Portuguese
  • Intermediate English
  • Postgraduate degree, specialization, or certification in Quality Management, Management Systems, or a related discipline
  • Validation and qualification methodologies
  • Risk and opportunity management
  • Knowledge of regulatory requirements for veterinary products under MAPA and household or institutional pesticide products under ANVISA
  • At least 3 years of experience in Quality Assurance, Quality Management Systems, or related areas
  • Advanced English
  • Intermediate Spanish

Neogen Corporation Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Neogen Corporation and has not been reviewed or approved by Neogen Corporation.

  • Healthcare Strength The benefits suite includes comprehensive medical, dental and vision coverage, plus disability, life insurance, and an Employee Assistance Program. These core coverages are consistently described as a relative bright spot.
  • Retirement Support A defined-contribution 401(k) with company match and immediate vesting is highlighted, alongside standard retirement and savings programs. This structure provides clear baseline retirement support for eligible roles.
  • Equity Value & Accessibility An employee stock purchase plan offers discounted access to company shares. This adds an ownership pathway that complements cash compensation.

Neogen Corporation Insights

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The Company
HQ: Lansing, MI
1,160 Employees
Year Founded: 1982

What We Do

NEOGEN Corporation develops and markets products dedicated to food and animal safety. The company’s Food Safety Division markets dehydrated culture media and diagnostic test kits to detect foodborne bacteria, natural toxins, genetic modifications, food allergens, drug residues, plant diseases and sanitation concerns. NEOGEN’s Animal Safety Division markets a complete line of diagnostics, veterinary instruments, veterinary pharmaceuticals, nutritional supplements, disinfectants and rodenticides.

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