QA Operations Specialist: Quality, Compliance & Improvement

Morgan McKinley; Dunboyne; On-site; EUR 65,000 - 90,000; Full time

Job summary

Morgan McKinley is seeking a QA Operations Specialist for a single-use multi-product biotech facility in Ireland. You will provide QA oversight across clinical and commercial operations, ensuring quality control, regulatory compliance and data integrity.

You will collaborate with Manufacturing, MS&T, and Engineering, drive CAPA and change control processes, support batch documentation reviews, and help implement new quality systems while maintaining GMP standards.

Qualifications

• Degree or post-graduate qualification in Science, Pharmacy or equivalent.
• Minimum 3 years experience in biotechnology or pharmaceutical industry.
• Experience with deviation management/Change controls.
• Experience in batch record review preferred.
• Knowledge of cGMP regulations domestically and internationally.
• Proven decision-making capability with full accountability and responsibility.
• Ability to think logically and be proactive under pressure.
• Ability to work as part of a team and on own initiative in a constructive manner.
• Flexible and self-motivated.

Responsibilities

• Provide QA oversight to clinical and commercial operations across quality control, supply chain, engineering and manufacturing.
• Support process technical transfers, analytical technical transfers, drug substance disposition and regulatory approvals.
• Support execution of an effective Quality system and QA oversight of quality management systems (CAPAs, Change Controls, Deviations, Batch Documentation Review).
• Liaises with internal partners in support of daily operations.
• Coordinate with peer Quality groups to ensure on-time disposition of commercial Drug Substance.
• Ensure clear communication on issues and timely escalation as applicable.
• Adhere to GMP regulations, cGMPs, company policies and budget management.
• Champion site metrics to ensure targets are achieved and counter measures are in place.
• Represent Quality on multidisciplinary teams and execute company policies.
• Deploy new/revised quality system requirements to the Site.
• Work independently and as part of a team; demonstrate problem solving and troubleshooting skills.

Skills

QA oversight

Quality systems

Problem solving

Team work

Communication

Education

Degree in Science/Pharmacy or equivalent

Job description

Morgan McKinley is seeking a QA Operations Specialist for a single-use multi-product biotech facility in Ireland. You will provide QA oversight across clinical and commercial operations, ensuring quality control, regulatory compliance and data integrity.

You will collaborate with Manufacturing, MS&T, and Engineering, drive CAPA and change control processes, support batch documentation reviews, and help implement new quality systems while maintaining GMP standards.