QA Specialist

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

An amazing opportunity has arisen for a QA Operations Specialist. This role will be responsible for supporting the clinical and commercials operational activities, at the single use multi-product biotech facility. You will works across site teams to resolve issues and drive quality, EHS, learning, and continuous improvement, while ensuring compliance with cGMP and corporate regulations.

What you will do:

Bring energy, knowledge, innovation and leadership to carry out the following:

• Provide QA oversight to the clinical and commercial operations at the facility including quality control, supply chain, engineering and manufacturing and support process technical transfers, analytical technical transfers, drug substance disposition and regulatory approvals.
• Responsible for supporting execution of an effective Quality system and accountable for quality oversight of quality management systems (CAPAs, Change Controls, Deviations Batch Documentation Review).
• Liaises with internal partners (e.g. Manufacturing Operations, MS&T, Engineering functions etc) in support of daily operations.
• Coordinate with peer Quality groups to ensure on-time disposition of commercial Drug Substance.
• Ensures clear communication on issues and timely escalation as applicable.
• Helps maintain site practices and procedures related to clinical and commercial operations.
• Responsibility for adhering to domestic and international GMP regulations, cGMP's, company policies, leadership behaviors, and performance and budget management.
• Champion site metrics to ensure targets are achieved, met and counter measures in place when applicable.
• Representing Quality on multidisciplinary teams.
• Executing company policies.
• Ensures new/revised quality system requirements are deployed to the Site.
• Ability to work on his/her own initiative in addition to working as part of a team
• Possess strong problem solving and trouble shooting skills

What skills you will need:

In order to excel in this role, you will more than likely have:

• Degree or post-graduate qualification in Science, Pharmacy or equivalent.
• Minimum 3 years' experience in the biotechnology and/or pharmaceutical industry.
• Previous Experience with deviation management/Change controls
• Previous Experience in Batch Record Review is preferable
• Knowledge of cGMP regulations both domestic and international.
• 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.