Job Description
An exciting opportunity has arisen for a Senior QC Analyst within the Global Quality Large Molecule Analytical Sciences QC team. As a Senior Analyst, your primary duties of this role will be part of Quality Control Testing Hub in the state-of-the-art single-use multi-product biologics facility in Dunboyne, County Meath, Ireland.
The QC Senior Analyst will support new product introductions, conduct biological, chemical, and physical analyses by using state-of-the-art laboratory instrumentation and computer systems at the new single-use multi-product biotech facility.
The overall responsibility for this role will be to support the Quality Control testing function, ensuring compliance with cGMP and corporate regulations. This is a critical role within the Quality organization to help establish the Laboratories as a hub for specialized analytical testing and create value for patients.
Bring energy, knowledge, innovation to carry out the following:
* A proven ability to deliver on tight timelines.
* Excellent influencing/collaboration skills and teamwork mindset.
* Excellent troubleshooting and problem-solving skills.
* Ability to challenge the status quo with a continuous improvement mindset.
* Ability to think logically and be proactive under pressure.
* Proven ability in using a wide variety of lean tools and building capability within teams.
* Change agent who will support the organization with good change management tools and techniques.
* Support creation of a focus on creating a continuous mindset organization through active coaching.
* Effective communicator with a proven ability to develop capabilities of others in a team.
* Demonstrated ability to give and receive feedback.
* Ability to work as part of a team and on own initiative in a constructive manner.
* Flexible and self-motivated.
* Promoting a culture where diversity and inclusion is part of the DNA.
* Establishes stretch goals for self to allow the SDWT or Hub Team to deliver on their priorities.
* Identifying and communicating risks in area of responsibility and across the site.
* Collaborates across the Network and continuous improvement teams across the Organization.
* For product quality, collaborates 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’.
What skills you will need:
In order to excel in this role, you will more than likely have:
* Degree Qualification (Science/Technical/Quality or related).
* 1-2 years’ experience in the biotechnology and/or pharmaceutical industry.
* Excellent written and oral communication skills.
* An understanding of cGMP requirements for Laboratory Operations and/or systems and compliance.
* Required to work on their own initiative in addition to working as part of a team.
* Excellent time management & organizational skills.
* An understanding of analytical methodology.
* An understanding of GMP, ICH, USP and global compendia regulations and guidance.
* Demonstrated understanding of continuous quality/process improvement tools (As defined by the site, e.g., DMIAC, Lean QA, 5S etc) desirable.
* Proven ability around working cross-functionally, focusing on meeting, and tracking to schedules and embracing an interdependent work culture.
* Organization Skills – Ability to manage multiple priorities and know when to escalate issues for resolution.
In Ireland, we work at the forefront of science and technology to advance manufacturing excellence and R&D across our Irish sites and global company network. We’re always looking to make a difference for people, patients, and communities – from Ireland to the world.
Our Commitment to Ireland:
We are one of Ireland’s leading healthcare companies, having first established here over 50 years ago. We have a dynamic and diverse team of over 3,000 employees currently working across seven sites in Ballydine, Co Tipperary, Brinny, Co Cork, Dunboyne, Co Meath, Carlow, and Dublin, where, in addition, we operate substantial Human Health and Animal Health businesses. Through our long-standing footprint in Ireland and over $6 billion invested across our Irish operations, our Irish sites manufacture many of the company’s top products, helping save and enhance lives in over 140 countries around the world.
The latest addition to the Ireland family is Dunboyne which joined our network in September 2020. Our Dunboyne site is the company’s first Biologics Drug Substance Single Use Commercialisation Facility, playing an important role in helping to commercialise key medicines as the newest addition to the company network. The cutting-edge innovation and collaboration between Dunboyne’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.
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.
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: Not Applicable
Shift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date: 04/30/2025
*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.
Requisition ID: R343300
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