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
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
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.
Experience within pharmaceutical, biotechnology or sterile manufacturing environments.
Experience managing: Deviations, CAPAs, Change Controls, Audit responses
Knowledge of FDA, HPRA, EMA or other regulatory requirements
Experience with electronic quality management systems (eQMS)
Ability to work effectively in a quick-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.

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📌 Quality Assurance Specialist (Ontario)
🏢 Arcadis
📍 Ontario