Job Description

A fantastic opportunity has arisen for a Drug Substance QA Operations Specialist (QA Ops) at our Dundalk facility.

The DS QA Ops Specialist provides direct Quality support to a production area as part of a Quality IPT (Integrated Product Team). With guidance from the Director/ Associate Director of Quality Operations, the Quality Specialist ensures quality and compliance of products manufactured by the functional area, adherence to Good Manufacturing and Documentation Practices, and represents quality on the shop floor.

The DS Quality Specialist performs review of process documentation/data for accuracy, completeness, and data integrity compliance. The incumbent may support the completion of batch disposition activities for release of product and may assist in conducting investigation of deviations. Additionally, the Quality Specialist spends significant time on the shop floor in a team environment to provide quality coaching and guidance, to enable documentation to be completed right first time, and to ensure compliance with cGMPs and regulatory requirements.

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

• QA support, review and approval of Commissioning and Qualification lifecycle documents for capital projects and new equipment.
• Will serve as the Quality SME for Performance qualification (PQ) activities across the site including but not limited to: Equipment, Facility and Utility PQ studies, Cleaning Validation, SIP, process validation.
• Be responsible for review/approval of new and updated Master Batch Records / Electronic Batch Records.
• Liaises with internal partners (e.g. Manufacturing Operations, Manufacturing, Science and Technology (MS&T), Engineering functions etc) in support of daily operations.
• Review and approve production/ area documentation to ensure accuracy and compliance with cGMPs and company procedures.
• Provide presence on the shop floor to support compliance and data integrity.
• Review and approve new and updated SOPs/ Work Instructions and Controlled Job Aids.
• Actively participate in the Tier process and uses this forum to make issues visible and to partner with the functional area on resolution.
• Participate as the quality member on cross functional projects.
• Support sustaining activities such as Change Management, Deviations and CAPAs.
• Provide support to internal audits and regulatory inspections.
• Collaborate with cross-functional team members in the identification and implementation of continuous improvement initiatives and action plans.
• Drive continuous improvement and utilise problem solving tools and MPS (our company's Production Systems) Participate in continuous improvement initiatives to enhance operational efficiency and resolve issues.

What skills you will need:

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

• Bachelor’s degree, in a scientific or engineering field (preferred); candidates with degrees in other fields will be considered if accompanied by significant relevant experience.
• Up to 5 years of relevant post-degree work experience in Manufacturing, Quality Assurance, Operations, Technical, or Regulatory function supporting manufacturing or laboratory operations.
• This role requires a professional with a working knowledge in the Biotechnology industry with specific understanding of QA operations an advantage, as well as Regulatory agency engagement.
• Evidence of good oral and written communication skills.
• Understanding of cGMPs and of regulatory requirements as they apply to the pharmaceutical field or a related area.
• Demonstrated interpersonal skills including flexibility, collaboration and inclusion skills and ability to work in a team environment.

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):

Required Skills:

Aseptic Manufacturing, Aseptic Manufacturing, Audits Compliance, Batch Releases, Biopharmaceutical Industry, Capital Projects, Change Management, Continual Improvement Process, Corrective and Preventive Action (CAPA), Data Integrity, Detail-Oriented, Documentation Review, Driving Continuous Improvement, GMP Compliance, Maintenance Management, Management Process, Periodic Reviews, Process Verification, Quality Assurance (QA), Quality Assurance Tools, Quality Auditing, Quality Management, Quality Management Systems (QMS), Quality Standards, Regulatory Compliance {+ 3 more}

Preferred Skills:

Job Posting End Date:

07/23/2025

*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.