Quality Assurance Specialist

Responsibilities

• Maintain and continuously improve the Quality Management System (QMS), including standard operating procedures (SOPs), work instructions, and documentation to ensure compliance with applicable regulations.
• Perform batch record reviews and oversee final batch release activities, including issuing Certificates of Conformance (CoC).
• Collaborate with cross-functional teams and external partners to resolve batch-related issues efficiently and effectively.
• Manage deviations, change controls, and CAPAs, ensuring comprehensive root cause analyses and thorough impact assessments.
• Partner with Operations and Engineering teams to ensure systems, production lines, and equipment are maintained in a state of compliance with GMP requirements.
• Identify, investigate, and resolve compliance issues; assess risk and implement corrective actions to minimize future occurrences.
• Lead and support continuous improvement initiatives focused on quality metrics and process optimization.
• Facilitate and lead the annual Management Review process.
• Develop and implement best practices to promote a culture of quality and cross-functional collaboration.
• Prepare regulatory documentation such as position papers and declarations to support compliance and quality decisions.
• Deliver training on cGMPs, QMS processes, and quality expectations to internal teams.
• Support standardization of quality procedures and practices across all organizational units.
• Drive quality-focused projects aimed at improving product and process performance, including implementation of new QMS tools.
• Conduct internal audits of the QMS and drive systemic improvements through the CAPA system to maintain inspection readiness.
• Support internal, external, and regulatory audits, including timely and effective response to findings and follow-up actions.
• Coordinate with departments to address post-inspection communications and develop sustainable CAPA plans.
• Promote ownership of quality responsibilities across all departments, ensuring integration into daily operations.
• Participate in customer technical meetings to address quality-related topics and align on expectations.

Qualifications

• Bachelor’s degree in a technical discipline (e.g., Engineering, Materials Science, Data Analytics, or Statistics) or equivalent experience.
• At least 2 years of experience in Quality Assurance, Quality Engineering, or Process Engineering in a regulated manufacturing environment.
• Strong verbal and written communication skills, with the ability to engage and train technical teams.
• Solid project management and analytical problem-solving abilities.
• Demonstrated use of risk-based decision-making in quality and compliance scenarios.
• Proficiency in technical writing and documentation.
• Working knowledge of ISO 9001, ISO 13485, and FDA cGMP requirements.
• Familiarity with quality control systems and manufacturing processes within the medical device, pharmaceutical, or life sciences industries.
• Experience with QMS tools and systems.
• Skilled in project and risk management frameworks and applications.

Company Overview

We are a global provider of advanced manufacturing solutions for the pharmaceutical, biotechnology, and life sciences sectors. Our mission is to support the development and delivery of critical therapies through innovative technologies, precision engineering, and a commitment to quality. Operating across multiple international locations, we serve a diverse client base with a focus on collaboration, compliance, and continuous improvement to meet evolving healthcare needs and improve patient outcomes.