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Associate Specialist Quality Control
Job in
Rahway, Union County, New Jersey, 07065, USA
Listed on 2026-03-01
Listing for:
MSD Malaysia
Full Time
position Listed on 2026-03-01
Job specializations:
-
Quality Assurance - QA/QC
Data Analyst, Regulatory Compliance Specialist
Job Description & How to Apply Below
Job Description For our Animal Health location Boxmeer, we are currently recruiting an
** Associate Specialist Quality Control Support
**** 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 and Quality Control laboratory
** in Boxmeer to bring our latest animal health innovations to market. Once the plant is fully operational (expected in 2030), it will create about 80–100 FTE jobs. The facility will include dedicated warehouse, manufacturing, quality, 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 an Associate Specialist Quality.
** Purpose of the role
** The purpose of this role is to act as the deputy Lab Manager and ensure the smooth execution of daily Quality Control laboratory operations. This includes planning, reviewing, writing and approving protocols, as well as the acting as subject matter expert with respect to Quality Control deviations, CAPAs, and GMP‑related changes, and providing GMP support to the Quality Control organization by coordinating compliance-driven projects.
The role promotes strong collaboration across teams, leads and participates in TIER meetings, and serves as a Subject Matter Expert (SME) during site audits, regulatory inspections, and corporate reviews. Additionally, the position contributes to cross-functional and global initiatives, supports laboratory investigations through impact assessments and root cause analysis, and upholds the highest standards of integrity, safety, quality, and environmental responsibility.
The role requires strong communication skills, a proactive and flexible mindset, customer focus, computer literacy, and a team-oriented approach to ensure the continued reliability and compliance of laboratory operations.
** Tasks and responsibilities**
* ** Act as subject matter expert for the QC support tasks and oversee daily operations.
*** Supports SAP/LIMS implementation, updates, and ongoing maintenance.
* Oversees equipment maintenance, calibration, and qualification activities.
* Performs QC investigations, including impact assessments (product, process, validation, etc.), Root Cause Analysis (RCA), and preparation of investigation protocols and deviation reports.
* Manages QC changes (e.g., analytical procedures), including writing and updating documents and associated analysis data sheets / CJA’s according to applicable guidelines.
* Coordinates and administers documentation related to deviations, CAPAs, and QC projects in compliance with site SOPs, company guidelines/procedures, and regulatory requirements.
* Orders laboratory supplies and ensures timely availability of materials.
* Guides QC personnel on quality-related matters and ensures implementation of quality improvements, procedures, and best practices.
** Your profile
*** A Bachelor’s degree (HBO or HLO), preferably in a scientific field, or equivalent relevant work experience.
* More than 3 years of relevant experience in Quality Control within the pharmaceutical industry.
* Yellow / Green Belt certified and applies continuous improvement methodologies.
* Solid knowledge of and experience with quality and compliance guidelines, including cGMP.
* Familiarity with industry guidance and regulations related to Stability program, Equipment Qualification, Quality Control, Quality (Management) Systems, Documentation, QC Deviations/CAPA, and Change Controls.
* Strong technical knowledge of testing techniques.
* Experience with Technical Writing, Root Cause Analysis, Failure Mode & Effect Analysis (FMEA), CAPA development, and Lean Six Sigma.
* Effective project management and planning skills, with the ability to communicate priorities clearly and align stakeholders.
* Ability to translate a quality-focused mindset into daily practice and bring others along.
* Excellent…
Position Requirements
10+ Years
work experience
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