Job Description

Arcadis are seeking a Quality Assurance Specialist to join a leading biopharmaceutical manufacturing facility in Waterford. Reporting to the Quality Assurance Team Leader, the successful candidate will provide day-to-day quality oversight and support to manufacturing operations, ensuring that products are manufactured and released in accordance with GMP requirements, regulatory expectations, and internal quality standards.

This role will work closely with Production, Quality Control, Engineering and Regulatory teams to support compliance, batch disposition activities, investigations, continuous improvement initiatives and audit readiness within a highly regulated sterile manufacturing environment.

Key Responsibilities

Quality Assurance Oversight

• Provide QA support to manufacturing and operational teams
• Ensure products are manufactured in accordance with cGMP requirements, company procedures and regulatory expectations
• Act as a Quality representative for assigned manufacturing processes and systems
• Provide guidance and support on quality-related issues across operations

Batch Record Review & Product Disposition

• Review batch documentation to ensure completeness, accuracy and compliance
• Support batch release activities and final product disposition
• Ensure timely review and approval of production records and associated documentation
• Escalate and investigate quality concerns impacting product disposition

Quality Systems Management

• Review and approve: Deviations, CAPAs, Change Controls, Quality Events, Investigations
• Ensure quality records are completed accurately and within required timelines
• Support root cause analysis and effectiveness checks

Compliance & Regulatory Support

• Ensure compliance with GMP, GDP and company quality systems
• Maintain inspection and audit readiness
• Participate in internal, customer and regulatory audits
• Support responses to audit observations and implementation of corrective actions

Continuous Improvement

• Drive quality improvements across manufacturing operations
• Analyse quality trends and recurring issues
• Support implementation of continuous improvement initiatives
• Monitor quality metrics and report performance indicators to management

Cross Functional Collaboration

• Partner closely with: Manufacturing, Quality Control, Engineering, Validation, Supply Chain
• Support timely closure of investigations and quality actions
• Promote a proactive quality culture across the site

Essential Requirements

• Bachelor's Degree in Science, Engineering, Biotechnology, Microbiology, Chemistry or related discipline.
• Previous experience within a GMP-regulated manufacturing environment.
• Experience working within Quality Assurance, Quality Control or Manufacturing Support functions.
• Experience reviewing quality documentation and investigations.
• Strong communication and stakeholder management skills.
• Excellent attention to detail and problem-solving abilities.

Desirable Requirements

• Experience within pharmaceutical, biotechnology or sterile manufacturing environments.
• Previous exposure to: Aseptic processing, Sterile manufacturing, Biologics production, Lyophilisation processes
• Experience managing: Deviations, CAPAs, Change Controls, Audit responses
• Knowledge of FDA, HPRA, EMA or other regulatory requirements
• Experience with electronic quality management systems (eQMS)

Key Competencies

• Ability to work effectively in a fast-paced manufacturing environment
• Strong analytical and investigation skills
• Ability to influence cross-functional stakeholders
• Team-oriented approach with a continuous improvement mindset
• Ability to balance compliance requirements with operational priorities

Why Join Arcadis?

At Arcadis, we empower individuals to excel because your contributions matter. Taking a skills-based approach, we provide opportunities for you to shape your career, maximize your impact, and grow professionally. By joining us, you’ll engage in meaningful work that drives sustainable solutions for a better planet while leaving a lasting legacy. Our Commitment to Equality, Diversity, and Inclusion We are dedicated to creating an environment where everyone can thrive. Through our six ED&I workstreams—Age, Disability, Faith, Gender, LGBT+, and Race— we foster innovation by bringing together diverse perspectives. Together, we strive to improve quality of life while building a more inclusive future.