Quality Document Specialist

Azzur Group is a premier consulting firm specializing in providing innovative solutions to the life sciences industry. Our expertise in quality assurance ensures that our clients' products, processes, and systems meet the highest standards of quality and regulatory compliance. Join us and contribute to projects that enhance product safety, efficacy, and reliability while working in a dynamic and collaborative environment.

We are seeking a detail-oriented and experienced Quality Assurance Specialist to join our consulting team. The Quality Assurance Specialist will be responsible for ensuring that products and processes comply with regulatory requirements and industry standards. The ideal candidate will have a strong background in quality assurance, excellent analytical skills, and a commitment to maintaining high standards of quality and compliance.

Key Responsibilities:

• Develop, implement, and monitor quality assurance processes and procedures to ensure compliance with industry regulations and company standards.
• Conduct audits and inspections of facilities, processes, and documentation to assess compliance and identify areas for improvement.
• Review and approve quality-related documentation, including standard operating procedures (SOPs), change controls, and validation protocols.
• Ensure that all quality assurance activities adhere to relevant regulatory guidelines, including FDA, EMA, and GMP standards.
• Maintain and update quality assurance documentation, including audit reports, corrective and preventive action (CAPA) plans, and deviation reports.
• Assist in the preparation of regulatory submissions and responses to regulatory agency inquiries.
• Investigate quality issues, deviations, and non-conformities, and implement corrective and preventive actions to address and resolve them.
• Collaborate with cross-functional teams to identify root causes of quality problems and develop effective solutions.
• Monitor and track the effectiveness of corrective actions and preventive measures.
• Provide quality assurance training and support to staff and stakeholders to ensure understanding and compliance with quality standards and procedures.
• Serve as a subject matter expert on quality assurance matters and provide guidance on best practices and regulatory requirements.
• Participate in continuous improvement initiatives to enhance quality assurance processes and systems.
• Contribute to the development and implementation of best practices and standard operating procedures (SOPs) to drive operational excellence.

Requirements

Qualifications:

• Bachelor’s degree in Life Sciences, Engineering, Quality Assurance, or a related field. Advanced degrees or specialized certifications are a plus.
• Minimum of 3-5 years of experience in quality assurance within regulated industries such as pharmaceuticals, biotechnology, or medical devices.
• Proven experience in conducting audits, investigations, and implementing corrective actions.
• Strong knowledge of quality assurance principles, regulatory requirements, and industry standards.
• Proficiency in quality management systems, documentation practices, and audit methodologies.
• Excellent analytical, problem-solving, and organizational skills.
• Effective communication and interpersonal skills, with the ability to work collaboratively with clients and team members.

Certifications:

• Relevant certifications (e.g., ASQ Certified Quality Auditor (CQA), ASQ Certified Quality Engineer (CQE)) are preferred but not required.

Benefits

• Health Care Plan (Medical, Dental & Vision)
• Retirement Plan (401k, IRA)
• Life Insurance (Basic, Voluntary & AD&D)
• Paid Time Off (Vacation, Sick & Public Holidays)