At a Glance
- Tasks: Ensure quality and compliance in a cutting-edge lab, testing gene therapy products.
- Company: Leading biotechnology organisation with a focus on innovation and quality.
- Benefits: Modern working environment, professional development, and growth opportunities.
- Other info: Collaborative culture with a strong commitment to quality and continuous improvement.
- Why this job: Join a high-performing team and make a real impact in advanced therapy products.
- Qualifications: Degree in a scientific discipline and experience in GMP environments.
The predicted salary is between 30000 - 40000 Β£ per year.
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.
- 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.
- 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.
QC Analytical Scientist employer: R&D Partners
As a leading organisation in the biotechnology sector, we pride ourselves on fostering a collaborative and high-performing work culture that prioritises quality and compliance. Our modern laboratory environment not only supports your professional development but also offers unique opportunities for growth within the pharmaceutical industry, ensuring that you play a vital role in advancing healthcare solutions. Join us to be part of a team that values integrity, innovation, and continuous improvement.