Job 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 Control Analyst to join one of our partner companies, a large pharmaceutical company leader in the field of biomedicines. This role is 1 full FTE, hybrid (3 days onsite and 2 days from home) in Leiden, NL, contract through June 2026. 5–8 years of experience in Quality Assurance within the pharmaceutical industry, with strong proficiency in nonconformances (NCs), CAPA, and change control processes.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 counterparts.Scope of the role:This role supports quality operations by executing routine and non-routine tasks, leading quality record activities, and coordinating team efforts. The employee helps meet company goals through their performance, communicates effectively, and ensures issues are escalated when needed.Main Job Tasks and Responsibilities:Applies expertise knowledge of Quality requirements to support the execution of Operations unit objectives.Perform nonconformance investigations, including CAPA records, and lead change controls (CC) for the Operations unit from initiation through completion.Reviews documentation associated with processes and activities for the Operations unit products.Maintains procedures and applicable documentation and makes updates based on new or revised regulatory requirements, internal investigations, and audits.Ensure compliant documentation and timely completion of quality records.Initiates and implements risk mitigations and continuous quality improvement projects, under limited guidance.Supports with formal escalation processes to ensure visibility of risks associated with safety, product quality, and regulatory compliance.Perform regular GEMBA walks to observe and document adherence to GMP standards on the production floor, identify areas for improvement, and collaborate with team members to implement corrective actions.Takes ownership of personal training and ensures that all required training is understood and completed on time.Enhance a culture of belonging through trusting, diverse, and inclusive relationships.Additional tasks and job duties of the position that are not required daily:Supports the Subject Matter Expert on non-conformances and Change Controls during inspections and audits.Supports developing training programs for general cGMP processes.Formulates responses to observations from audits and inspections.Conducts data analysis on recurring non-conformances and recommends corrective actions.Education and Experience:A relevant Master’s Biological degree with 5-8 years of quality assurance / control experience within the pharmaceutical industry. English B2 language level is required.Intermediate proficiency in MS Office.Routine proficiency in data analysis.Specialist-level proficiency in business applications.Positive attitude, proactive, decisive, and organized, with the ability to work independently and in a team.Stress-resistant and able to remain calm under pressure.High degree of accuracy and a strong quality mindset.Flexible and able to adapt to changing priorities.Demonstrates accountability by proactively addressing issues and taking responsibility for outcomes.Strong analytical thinking skills, including the ability to handle complexity, ask questions, use data and information effectively, identify gaps and root causes, and develop creative solutions.Effectively prioritizes tasks to meet deadlines and ensure timely delivery.Maintains alignment with stakeholders and builds meaningful connections with customers.Previous experience in leading or providing significant guidance on change controls or quality investigations.Open to giving and receiving transparent, constructive feedback; learns from mistakes and supports both organizational and personal growth.Coordinates team initiatives by providing clear direction and fostering effective collaboration.The Application ProcessOnce 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 ClinChoiceClinChoice 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 EthosOur 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 Assurance (QA), Quality Control (QC), Nonconformance (NC), CAPA (Corrective and Preventive Actions), Change Control (CC), GMP (Good Manufacturing Practices), Quality Records, Risk Mitigation, Continuous Improvement, Regulatory Compliance, Audit Support, Inspection Readiness, Documentation Review, Process Improvement, Deviation Management, Root Cause Analysis, Data Analysis, Training Development (GMP Processes), Quality Control Analyst#CONTRACT
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