Play a key role in ensuring quality and compliance in a cutting-edge laboratory environment.
A leading organisation in the biotechnology sector is seeking a QC Analytical Scientist to support quality control testing activities within a regulated laboratory environment. This role plays a key part in ensuring product quality, safety, and adherence to regulatory standards within a fast-paced, highly regulated setting.
Please note that to be considered for this role you must have the right to work in this location.
Responsibilities:
- Perform testing of gene therapy products in accordance with product specifications and GMP requirements.
- Support environmental monitoring schedules and facility-related testing activities.
- Operate and maintain laboratory equipment, ensuring proper calibration and readiness.
- Record and investigate out-of-specification (OOS) results and non-conformances, implementing corrective actions where required.
- Assist in the development and maintenance of SOPs and laboratory documentation.
- Maintain effective communication within the Quality Control team and ensure accurate document control.
- Complete required training and support training initiatives for team members.
- Ensure QC facilities remain compliant with GMP standards and support inspections or site visits.
- Contribute to the maintenance of the Quality Management System and ensure data integrity.
- Support internal and external audits.
- Assist in introducing new analytical methodologies.
Key Performance Indicators
- Timely completion of QC testing in line with production schedules and KPIs.
- Effective planning, tracking, and completion of training.
- Maintenance of laboratory environments in compliance with GMP standards.
- Analytical Thinking: Ability to interpret complex data and support decision-making.
- Problem Solving: Identifies issues efficiently and implements effective solutions.
- Collaboration: Works effectively within teams and supports cross-functional activities.
- Quality Focus: Demonstrates accuracy, attention to detail, and commitment to continuous improvement.
- Communication: Strong verbal and written communication skills.
- Professionalism: Maintains accountability, integrity, and respect in all interactions.
Key Requirements
- Degree in a scientific discipline (e.g., Human Health, Life Sciences) or equivalent experience in a regulated industry.
- Experience working in GMP environments and quality control functions.
- Knowledge of EU and FDA regulations, GMP/GLP/GCP standards, and continuous improvement methodologies (e.g., Lean, Six Sigma).
- Proficiency in Microsoft Office applications (Word, Excel, PowerPoint).
About the Role
You will join a collaborative and high-performing team focused on maintaining the highest quality standards for advanced therapy products. The organisation offers a modern working environment, strong focus on professional development, and opportunities to grow within the pharmaceutical and biotechnology industry.
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