QC Specialist

Job Description

Our facility in Dunboyne joined our network in September 2020. Our Dunboyne site is our Company’s first Biologics Drug Substance Single Use Commercialisation Facility, playing an important role in helping to commercialise key medicines. The cutting-edge innovation and collaboration between our Company’s research and manufacturing teams will significantly accelerate the time it takes to bring a medicine to market for the benefit of patients around the world.

An exciting opportunity has arisen in Dunboyne for a QC Specialist within the Global Quality Large Molecule Analytical Sciences QC team.

What you will do:

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

• Excellent influencing/collaboration skills and teamwork mindset.
• Excellent trouble shooting and problem-solving skills.
• Ability to challenge the status quo with a continuous improvement mindset.
• Proven ability in using a wide variety of lean tools and building capability within teams.
• Change agent who will support the organisation with good change management tools and techniques.
• Support creation of a focus on creating a continuous mindset organisation through active coaching.
• Demonstrated ability to give and receive feedback. Excellent trouble shooting and problem-solving skills. Develop and coach the Quality Control team and drive a high-performance organisational culture that accommodates rapid growth and highly dynamic expectations, ensuring attainment of site operational and development goals.
• Establishes stretch goals for self to allow the SDWT or Hub Team deliver on their priorities.
• Identify and communicate risks in area of responsibility and across the site.
• Collaborate across the Network and continuous improvement teams across the Organisation.
• Product quality- collaborate with Process Development Technical Services (PDTS) and Manufacturing Operations but is responsible for providing information to support the QMR decision.
• For safety, the individual is accountable to drive a culture of ‘everyone owns safety’
• Provide support and expertise for the preparation of regulatory submissions, inspection readiness, health authority inspections including interaction with inspectors, responses to inspection observations, and monitoring of follow up actions.

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

• Degree Qualification (Science/Technical/Quality or related)
• 3-5 years’ experience in the biotechnology and/or pharmaceutical industry,
• Experience in Deviations/Change Controls is essential
• Demonstrated understanding of continuous quality / process improvement tools (As defined by the site, e.g., DMIAC, Lean QA, 5S etc) desirable.
• Strong technical writing skills
• Proven ability around working cross functionally, focusing on meeting, and tracking to schedules and embracing an interdependent work culture.
• Evidence of continuous professional development is
• Organisation Skills – Ability to manage multiple priorities and know when to escalate issues for resolution.

We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs.

As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together.

Please don't hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.

We are committed to flexible working where possible, and this is why our Company has introduced a new hybrid working model for office-based colleagues around the world.

Please feel free to speak to us about what flexibility means to you during your application.

So, if you are ready to:

Invent solutions to meet unmet healthcare needs, please apply today.

Required Skills:

Change Controls, Cross-Functional Collaboration, Deviations, Documentation Review, FDA Regulations, Interpersonal Relationships, Laboratory Quality Control, Lean Design, Meeting Deadlines, Technical Writing

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully
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:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

05/27/2026

***A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. **