Job Title: Quality Engineer/Quality Specialist

Job Description

We are seeking a highly experienced and motivated Quality Engineer to join our pharmaceutical manufacturing team. The ideal candidate will have a strong experience in quality assurance within the pharmaceutical industry, with a comprehensive understanding of regulatory requirements, quality systems, and process improvements. This role is critical to ensuring compliance with all relevant regulations and standards, leading quality initiatives, and supporting the manufacturing of pharmaceutical products.

Responsibilities

• Develop, implement, and maintain Quality Management Systems (QMS) in compliance with FDA, EMA, ICH guidelines, and other regulatory requirements.
• Ensure all processes and products comply with applicable regulatory standards, including cGMP.
• Lead continuous improvement initiatives to enhance product quality, efficiency, and compliance.
• Oversee validation activities, including equipment, process, and cleaning validations, ensuring compliance with industry standards.
• Conduct thorough investigations into quality issues, perform root cause analysis, and implement corrective and preventive actions (CAPA).
• Plan and conduct internal audits, support external regulatory inspections, and manage responses to audit findings.
• Evaluate and qualify suppliers, conduct supplier audits, and ensure supplier compliance with quality standards.
• Maintain accurate and comprehensive quality documentation, including SOPs, batch records, and validation protocols.
• Mentor and develop junior quality engineers and quality assurance staff, fostering a culture of continuous improvement and quality excellence.
• Perform risk assessments and implement risk mitigation strategies related to product quality and regulatory compliance.
• Work closely with cross-functional teams, including R&D, manufacturing, and regulatory affairs, to ensure quality considerations are integrated into all phases of product development and production.

Essential Skills

• 7-10 years of experience in Quality Assurance within a FDA/GMP environment (pharmaceutical or medical device industry required).
• Bachelor’s degree in a scientific field (Life Sciences, Biotechnology, or equivalent) is required.
• Proficiency in quality management software, statistical analysis tools, and methodologies such as Six Sigma and Lean.
• Strong understanding of Quality Management Systems.
• Experience with Quality Systems including change control, root cause analysis, deviations, documentation management, and training systems.
• Experience with electronic Quality and Training Management Systems.
• Previous experience with hosting client audits and/or regulatory inspections required with excellent communication skills.

Additional Skills & Qualifications

• Certified Quality Engineer (CQE) or Certified Quality Auditor certification preferred.
• Knowledge of FDA, EMA, ICH guidelines, and cGMP regulations.

Work Environment

This position involves office/desk work in a Monday-Friday role with normal day hours. Flexibility is offered as long as core hours are met. You will have the opportunity to work with large-scale biological and chemistry pharma operations, contributing to impactful work that supports making biologics used for pharmaceutical products.