Job Description
Carlow is offering an amazing opportunity for a Quality Assurance Specialist to join our quality team. In this role, you will play a vital role in supporting the introduction and execution of new products and materials at our Carlow facility, while also overseeing Supplier Management.
As the QA Specialist for New Product Introduction (NPI) and Supplier Management, you will be an essential member of our esteemed Technical Transfer Team. This team holds responsibility for managing the development and manufacture of vaccines and biological products. Alongside your day-to-day QA activities, your main focuses will be ensuring the compliance of the introduction process for biologics and vaccines with cGMP and associated regulatory requirements, as well as reviewing and approving documentation to support corporate compliance and regulatory expectations for manufacturing.
You will directly report to the Associate Director of Quality and collaborate closely with cross-functional teams on-site, particularly Supply Chain, Technical Engineering, and Operations. Your key objective will be to ensure that manufacturing, technical, and regulatory requirements are met.
What you will do:
Bring energy, knowledge, innovation, and leadership to carry out the following:
Provide quality oversight and direction for the introduction of new products and materials, as well as manage external parties.
Serve as the point of contact for quality at both the site level and with external inputs, coordinating and attending Quality working group meetings.
Participate as a functional expert in the cross-functional team responsible for introducing products and materials at Carlow.
Conduct quality reviews and approvals of engineering/validation/automation/utilities commissioning and qualification activities.
Author, review, and approve protocols and reports for technology transfer, method qualification, and method validation.
Review documentation associated with new product and material introduction, such as Material Packs, QC Test Specifications, BOMs, and MES documentation.
Develop and monitor supplier performance metrics, participate in material review boards and quarterly reviews of key suppliers, and actively engage in cross-functional forums as needed.
Maintain the approved supplier management list within the qualified Supplier Management system, ensuring correct setup of suppliers and materials used at Carlow.
Support deviation and atypical closeout, as well as initiate and follow up on corrective and preventive actions.
Facilitate compliance direction for the site by adhering to divisional policies, guidelines, and regulatory requirements. Proactively evaluate site compliance against emerging trends and initiate major compliance initiatives for improved status and operational efficiency. Actively participate in Plant/Quality committees and collaborate with other site functional groups.
What skills you will need:
In order to excel in this role, you will more than likely have:
A Bachelor's degree or higher in a related Science discipline is preferred.
A minimum of 3-5 years of experience in a quality role, ideally in a pharmaceutical manufacturing environment.
Knowledge of regulatory/code requirements related to Irish, European, and International Codes, Standards, and Practices.
Familiarity with cGMP (current Good Manufacturing Practice) and GDP (Good Distribution Practice) is preferred.
Strong report, standards, and policy writing skills.
Experience with equipment and process validation.
Familiarity with sterile filling processes and equipment.
Proficiency in Microsoft Office and job-related computer applications.
Experience or familiarity with Lean Six Sigma methodology is desired.
Good collaboration skills and the ability to work effectively as part of a team to determine priorities.
Demonstrated ability to work independently and take ownership of improvement initiatives with a moderate level of guidance.
Proven ability to drive the completion of tasks.
Strong decision-making capability with a sense of accountability and responsibility.
Demonstrated problem-solving skills.