Quality Auditor – III

Job Description

Job Summary:

• The main function of a Quality Auditor is to evaluate and ensure that products, services, and processes meet established quality standards and regulatory requirements.
• A typical Quality Auditor conducts audits, documents findings, and recommends corrective actions to improve compliance and performance.
• The Quality Auditor usually reports to a Quality Assurance Manager or Compliance Lead.

Duties & Responsibilities:

• Conduct documentation Review quality control procedures and ensure adherence to company and regulatory standards Identify non-conformances and recommend corrective and preventive actions (CAPAs) Collaborate with cross-functional teams to resolve quality issues Monitor implementation of corrective actions and verify effectiveness Assist in developing and updating quality assurance policies and procedures Stay current with industry regulations, standards, and best practices.
• Initial QAV Validation Responsibilities.
• Review protocols, change controls, SOPs, and validation documentation.
• Support compliance assessments and documentation review activities.
• Conduct quality reviews to ensure adherence to internal procedures and regulatory requirements.
• Participate in validation project execution and documentation management.
• Future Digital Quality Responsibilities.
• Support digital quality initiatives and electronic quality management processes.
• Review and manage electronic batch records and associated documentation.
• Utilize digital quality platforms and software tools to support quality operations.
• Assist with system implementation, optimization, and data-driven quality improvements.
• Partner with cross-functional teams to enhance digital workflows and process efficiencies.

Required Skills:

• Strong attention to detail and analytical thinking Excellent verbal and written communication skills Ability to work independently and manage multiple audits Familiarity with quality management systems (e.g., ISO 9001, GMP, FDA regulations).
• Proficiency in Microsoft Office and audit documentation tools Strong interpersonal and collaboration

Required Qualifications:

• Bachelor’s degree in Engineering, Life Sciences, Information Systems, Computer Science, or a related field.
• Experience working with digital quality systems, electronic documentation systems, manufacturing systems, or related digital platforms.
• Strong technical aptitude with the ability to learn validation and quality processes.
• Excellent organizational, analytical, and communication skills.
• Ability to adapt to evolving project requirements and responsibilities.
• High school diploma or GED typically required; associate or bachelors degree preferred 5-7 years of experience in quality assurance, auditing, or compliance roles.

Preferred Qualifications:

• Experience in pharmaceutical, biotechnology, medical device, or regulated manufacturing environments.
• Familiarity with electronic batch records, quality management systems, or validation activities.
• Experience supporting digital transformation, process automation, or data management initiatives.
• Exposure to systems such as electronic documentation platforms, manufacturing execution systems (MES), or similar quality technologies.