An exciting opportunity has arisen for a QA Specialist in the Biologics INnovation Xceleration (BioNX) facility, at our site in Dunboyne.

Reporting to the Associate Director of QA Operations within Global Development Quality (GDQ), the QA Specialist role will support the Quality Assurance activities at the BioNX, Research & Development Division facility in Dunboyne.

The QA specialist is a key member of the quality team ensuring the site has a strong operational compliance focus which is aligned with the principles and expectations of cGMP regulations.

The BioNX start-up facility will utilize the latest innovations in technology and automation, where you will work as part of a high performing cross-functional team. Together, we will build the future through a culture that delivers safety first, quality always to our patients.

You will be responsible for maintaining cGMPs for assigned areas in conformance with policies and in compliance with cGMPs and Health Agency regulations and all other applicable governing regulations. You will have fulfilled the educational requirements for this role and have the necessary experience within an FDA/EMEA regulated environment. You will be actively supported and encouraged to continue your development and knowledge build, incorporating areas to support your future development and ability to continuously improve in the current role.

The candidate will provide quality support to the site, including training and guidance on the interpretation and implementation of company Guidelines / Policies and regulatory requirements, as required.

What you will do:

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

• 
  Participate daily on cross-functional teams to collaboratively actively to address compliance issues and achieve project start-up milestones.
• Participating in investigations and risk assessments related to deviations/ complaints and changes, ensuring appropriate actions are implemented timely.
• Provide QA review and approval of Change Controls, Deviations/CAPAs, SOPS and related documentation for compliance to GMP and site requirements at the start-up facility.
• Provide QA oversight to the qualification/validation, technical transfers, regulatory approvals and commercial operations at the start-up facility.
• Complete QA operational duties related to product disposition including the performance of detailed review of eBR prior to QP release.
• Assist in the development of training curricula and records for the QA Operations Group, providing SME training on Quality Assurance SOPs as required.
• Assist in the creation and maintenance of QA policies, SOP’s and reports in line with site requirements.
• Support an environment of continuous improvement by identifying and implementing efficiencies and quality improvements.
• Work collaboratively to foster strong relationships with management and colleagues and to drive a safe and compliant culture in BioNX.
• Participate in and support risk management activities in line with relevant guidance and best industry practice.
• Ensures the escalation of compliance risks to management in a timely manner.

What skills you will need:

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

• Degree qualification (Science/Quality/Technical).
• 4-7 years’ experience, ideally in Quality Assurance, Quality Control or Technical Operations within the Biological industry.
• Previous experience in QRM, participating in investigations and problem solving.
• Strong written and verbal communication skills.
• 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.
• Strong attention to detail and precision in preparing and reviewing GMP documentation.
• Previous experience in eBR systems such as PAS-X.
• Previous experience with Quality Management Systems i.e Veeva Vault and SAP.
• Previous experience working in a sterile/low bioburden environment.
• Knowledge of industrial regulations including those of FDA, HPRA, EMEA and other authorities related to Biologics and/or Pharmaceuticals.

Desirable:

• Previous experience interacting with regulatory agencies.

As a company, we are committed to 'Inventing for Life' in all that we do. 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 or click on the link to find out more about our hybrid working model

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

Requisition ID:R212199