More jobs:
Associate Specialist Quality Control Chemical
Job in
Rahway, Union County, New Jersey, 07065, USA
Listed on 2026-02-28
Listing for:
MSD Malaysia
Full Time
position Listed on 2026-02-28
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist
Job Description & How to Apply Below
** Associate Specialist Quality Control Chemical**.
** Welcome to our team
** Our production facilities in Boxmeer are part of our global Animal Health production network and manufacture and package animal health products according to Good Manufacturing Practice standards (GMP). Currently, we are investing in a new EU‑ and FDA‑compliant manufacturing facility, which includes a Quality Control laboratory, in Boxmeer to bring our latest animal health innovations to market. Once the manufacturing facility is fully operational (expected in 2030), it will create about 80–100 FTE jobs.
The facility will include dedicated warehouse, manufacturing, quality assurance, quality control, and packaging & labeling teams to deliver high‑quality, compliant products. To accelerate delivery of robust, compliant, and future‑proof Quality Systems that will enable safe and compliant product manufacture, we are looking for a Specialist Quality.
** Purpose of the role
** The purpose of this role is to support and deputize for the Lab Manager by ensuring smooth and compliant daily quality control laboratory operations. This includes oversight of planning, execution, review, and approval of test results, as well as acting as subject matter expert with respect to QC deviations, CAPAs, and GMP‑related changes. The role provides essential GMP support to the QC organization by coordinating and driving compliance‑focused projects that maintain the integrity of laboratory processes.
Beyond operational responsibilities, the role ensures high‑quality execution of quality control activities through strong project management, clear prioritization, and effective communication to align and guide stakeholders. It translates a quality‑driven mindset into practical daily practices and supports others in adopting these standards. Success in this role requires solid digital literacy, a strong client‑ and end‑user‑focused approach, proactive and flexible communication, and a collaborative, team‑oriented attitude.
Demonstrating a flawless integrity mindset in all decisions and actions is fundamental to ensuring consistent compliance and operational excellence.
** Tasks and responsibilities*
* • Act as subject matter expert for the QC chemistry laboratory and manage daily operations.
• Perform QC investigations, including impact assessments (product, process, validation), Root Cause Analysis (RCA), and preparation of investigation protocols and deviation reports.
• Manage QC chemistry‑related changes (e.g., analytical procedures), including writing and updating documents and associated analysis data sheets/CJAs.
• Coordinate and administer documentation related to deviations, CAPAs, and QC projects in compliance with site SOPs, company guidelines/procedures, and regulatory requirements.
• Participate in site audits, regulatory inspections, and corporate audits, including providing SME support for audit responses.
• Attend and lead TIER meetings.
• Conduct and support stability studies.
• Always adhere to GxP and safety guidelines. Write, review, and modify technical reports, instructions, and procedures within relevant discipline(s).
• Guide QC personnel on quality issues and ensure implementation of quality improvements, procedures, and guidelines.
• Participate in cross‑functional and global teams.
• Actively contribute to corporate safety, health, and environmental policies, demonstrating personal commitment to safe, healthy, and environmentally responsible working practices.
** Your profile*
* • Bachelor degree (HBO or HLO) in (Bio)
Chemistry, Analytical Science, or a related scientific field, or comparable work experience.
• More than 3 years of relevant Quality Control experience in the pharmaceutical industry.
• Knowledge and experience with quality and compliance guidelines, cGMPs (EU and preferably US FDA).
• Knowledge of industry guidance and regulations for Analytical Methods Validation, Equipment Qualification, Quality Control, Quality (Management) Systems, Documentation, QC Deviations/CAPA, and Change Controls.
• Technical…
Position Requirements
10+ Years
work experience
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