Quality Control Analyst at ClinChoice

Leiden, South Holland, Netherlands -

Full Time

Start Date

Immediate

Expiry Date

28 Dec, 25

Salary

0.0

Posted On

29 Sep, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, GMP, Analytical Thinking, Problem Solving, Microbiological Techniques, Deviation Management, Technical Support, Continuous Improvement, Documentation, Collaboration, Communication, Safety, Compliance, Reliability, Technical System Ownership, Client Interaction

Industry

Pharmaceutical Manufacturing

Description

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds…. ClinChoice is searching for a Quality Assurance Analyst to join one of our partner companies, a large pharmaceutical company leader in the field of biomedicines, where you will work in a hybrid model in Leiden, 1.0 FTE until October 2026. ClinChoice is a global full-service CRO with a strong focus on quality, professional development and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client counter-parts. Scope of the role: In this position you will actively handle the Medium and High quality and compliance issues at the lab independently or with the help of the lab technicians. Will work to maintain cGMP compliance and LEAN status of the team. Act as Subject Matter Authority during cGMP inspections and is SPOC (Single point of contact) for the lab during new product implementations, investigations, qualifications, etc.. Main Job Tasks and Responsibilities: Responsible for deviation management, acting as lead investigator for non-conformances and coordinator of appropriate corrective/preventive actions. Creates, reviews and updates lab documentation and supporting documents for New Product Introductions. Provides technical support to the lab, input in services group and cooperates with local/global customers. Acts as a technical system owner for (analytical) equipment. Acting as Subject Matter Authority during audits and inspections. Leads and drives continuous improvement projects. Role model to safety, compliance, and reliability Responsible to communicate and interact effectively with team members; develop credibility and trust mutually respected relationships with customers, supervisors, and team members. Education and Experience: Bachelor’s degree (HLO) or higher education in Life Sciences, molecular biology or comparable. Ability to work independently as well as collaborate with cross-functional teams to accept challenges and responsibilities. Proven experience with microbiological techniques, such as bioburden, endotoxin, and sterility is preferred. Analytical thinking and (technical) problem solving. GMP experience is a plus. Proficiency in written and oral English, with a desirable command of Dutch. The Application Process Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful. Who will you be working for? About ClinChoice ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. Our Company Ethos Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates. ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it. Key words: Quality Control Analyst, Quality Assurance, GMP, CAPA, GMP, Laboratory, CRO, Contract Research Organisation, Outsourced, Outsourcing, Sponsor-dedicated. #LI-CM1 #LI-HYBRID #CONTRACT

Responsibilities

The Quality Control Analyst will handle medium and high-quality compliance issues at the lab, ensuring cGMP compliance and acting as the Subject Matter Authority during inspections. Responsibilities include deviation management, documentation updates, and providing technical support to the lab.