Categories: Pharmaceutical, Quality Assurance, Manufacturing

Job Description

An amazing opportunity has arisen for an Associate Quality Specialist.

The Associate Quality Specialist is responsible for supporting day‑to‑day Quality Assurance activities at the facility and serves as an integral member of the Quality Systems Centre of Excellence (CoE) Team. This role ensures compliance with global quality standards, supports key quality systems, and contributes to continual improvement initiatives across the site.

What you will do:

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

• Serve as a functional quality expert within cross‑functional teams to support Right‑First‑Time performance across site operations.
• Support regulatory submissions, market renewals, and GMP declarations by providing timely and accurate QA input.
• Act as the site coordinator for Quality Agreements (QAs) & Change Agreements (Cas), including oversight of the QA and CA register, execution of periodic reviews, and creation or revision of agreements as required.
• Support SAP Master Data creation, updates, and governance activities.
• Provide QA support for deviation investigations and process performance monitoring; perform deviation trending to identify patterns and drive improvement initiatives.
• Apply strong knowledge of quality systems to ensure robust root cause identification and effective Corrective and Preventive Actions (CAPA).
• Provide guidance on quality and compliance requirements related to maintaining validated status, including participation in risk assessments for products and processes.
• Identify and communicate recurring issues, contributing to continuous improvement of systems and processes.
• Ensure change controls are thoroughly documented, assessed, progressed, and completed in a timely manner.
• Prepare Annual Product, Process, and System Reviews to support ongoing compliance.
• Act as lead or team auditor for internal GMP walkdowns and scheduled audits.
• Contribute to the development, analysis, and communication of site quality metrics.
• Create, review, and approve quality procedures, ensuring alignment with current regulatory and corporate standards.

What skills you will need:

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

• Degree or postgraduate qualification in Science, Pharmacy, or a related discipline.
• Experience with Quality IT systems desirable (e.g., SAP, ProCal, Veeva Quality Docs, Kneat).
• Demonstrated knowledge and practical application of Lean principles / Continuous Improvement methodologies.
• Understanding of Quality Agreements and Change Agreements.
• Knowledge of SAP Master Data governance.
• Experience in high‑potency manufacturing is desirable.
• Communication - Demonstrates excellent written and verbal communication skills; conveys information clearly and appropriately across diverse audiences.
• Teamwork - Collaborates effectively with colleagues; willingly shares information and supports team objectives.
• Decision Making - Exercises sound judgment using data‑driven insights; makes well‑informed decisions that support compliance and operational performance.
• Adaptability - Responds effectively to changing priorities, environments, and stakeholder needs; comfortable working across diverse functions.
• Work Standards - Maintains high standards of accuracy, precision, and completeness; demonstrates strong attention to detail.
• Motivation - Shows initiative, energy, and enthusiasm; maintains high productivity and self‑direction in a dynamic 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. 

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment.

So, if you are ready to:

Invent solutions to meet unmet healthcare needs, Impact the future by driving one of the world’s leading healthcare companies, and inspire your team to reach their full potential and push the boundaries of science and technology, please apply today.

Required Skills:

Accountability, Accountability, Analytical Problem Solving, Aseptic Filling, cGMP Compliance, Communication, Complaint Management, Decision Making, Deviation Management, GMP Compliance, Good Manufacturing Practices (GMP), Performance Monitoring, Pharmacokinetics, Pharmacology, Preventive Action, Quality Assurance (QA), Quality Assurance (QA) Standards, Quality Assurance Processes, Quality Auditing, Quality Management Standards, Quality Management Systems (QMS), Quality Process Development, Quality Standards, Quality Support, Risk Assessments {+ 4 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:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

02/3/2026

*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.