QA Operations Specialist

Job Description

An amazing opportunity has arisen for a QA Operations Specialist. This role will be responsible for supporting the clinical and commercial operations at the Dunboyne single use multi-product biotech facility.

What you will do:

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

• The motivation to be an inspiring member of a high performing team.
• The desire to continuously learn, improve and develop.
• Provide QA oversight to the clinical and commercial operations at the facility including quality control, supply chain, engineering and manufacturing and support process technical transfers, analytical technical transfers, drug substance disposition and regulatory approvals.
• Review/Approval of validation/qualification/verification protocols and reports associated with new product and new material introduction.
• Supporting execution of an effective Quality system and accountable for quality oversight of quality management systems (CAPAs, Change Controls, Deviations and Batch disposition review).
• Adhere to domestic and international GMP regulations, cGMP’s, company policies, leadership behaviours, and performance and budget management.
• The candidate will have strong problem solving and trouble shooting skills

What skills you will need:

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

• Degree or post-graduate qualification in Science, Pharmacy or equivalent.
• Minimum 3 years’ experience in the biotechnology and/or pharmaceutical industry.
• Previous Experience with deviation management/Change controls
• Previous experience in material and drug substance disposition/release preferrable
• Knowledge of cGMP regulations both domestic and international.
• Proven decision-making capability with full accountability and responsibility.
• 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.
• Flexible and self-motivated.

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 Partner assigned to this role should you need any support during our recruitment process.

So, if you are ready to:

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

Required Skills:

Accountability, Accountability, Aseptic Manufacturing, Audits Compliance, Biopharmaceutical Industry, Biotechnology, Corporate Productions, Corrective and Preventive Action (CAPA), Detail-Oriented, Documentation Review, Driving Continuous Improvement, GMP Compliance, Innovation, IS Audit, Leadership, Motivation Management, Quality Assurance (QA), Quality Assurance Tools, Quality Auditing, Quality Management System Auditing, Quality Management System Improvement, Quality Management Systems (QMS), Quality Operations, Quality Standards, Root Cause Analysis (RCA) {+ 3 more}

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:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

01/6/2026

*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.