Quality Assurance Internship

Job Description

Quality Assurance Intern

We are offering an amazing opportunity for a Quality Assurance Intern to join our quality team at our Carlow facility. In this role, you will play a vital role in supporting the introduction of new products and overseeing the execution of validations.

As a member of our esteemed Technical Transfer/Validation Team, you will manage the development and manufacture of vaccines and biological products. Your main focus will be to provide Quality oversight, support, and approval of validation documents relating to a sterile facility, ensuring compliance with corporate and regulatory expectations for manufacturing.

Responsibilities

• Provide quality oversight and direction for the introduction of new products and validation activities.
• 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 at Carlow.
• Conduct quality reviews and approvals of engineering/validation/automation/utilities commissioning and qualification activities.
• Review and approve protocols and reports for technology transfer, method qualification, and method validation.
• Review documentation associated with new products, such as QC Test Specifications, BOMs, and MES documentation.
• Support deviation investigations and close out in a timely manner.
• 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.

Qualifications:

• Currently pursuing a Bachelor's degree or higher in a related Science discipline.
• Knowledge of regulatory/code requirements related to Irish, European, and International Codes, Standards, and Practices.
• Proficiency in Microsoft Office and job-related computer applications.
• 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.
• Familiarity with cGMP (current Good Manufacturing Practice) and GDP (Good Distribution Practice).
• Strong Continuous Improvement Mindset.

So, if you are ready to invent solutions to meet unmet healthcare needs, impact the future by driving one of the world’s leading healthcare companies, and inspire your team to reach their full potential and push the boundaries of science and technology, please apply today.

PQ20

Required Skills:

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

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