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- Tasks: Lead quality control for cell therapy products, ensuring compliance with regulatory standards.
- Company: Join a cutting-edge GMP manufacturing center focused on innovative cellular therapies.
- Benefits: Enjoy a collaborative work environment with opportunities for professional growth and development.
- Why this job: Make a real impact in healthcare while working with passionate teams and advanced technologies.
- Qualifications: Experience in quality control and knowledge of GMP regulations are essential.
- Other info: Be part of a dynamic team that values innovation and quality in every project.
The predicted salary is between 43200 - 72000 £ per year.
This range is provided by Northreach. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range Direct message the job poster from Northreach Growing Biotech Start Ups effectively – Immunology / Cell & Gene Therapy- CAR-T / TCR/ NK Cells / Tregs / CMC / Quality Control / Analytical… Overview: This role provides Quality support to manufacturing operations and quality control, ensuring the production and testing of cell therapy products for clinical use within a shared GMP manufacturing centre. Key Responsibilities: Manage and perform QC duties to ensure compliance with GMP, GCP, HTA, and other regulatory requirements related to the manufacture and clinical trials of cellular therapies and ATMPs, including: Document control system Training system Change controls Corrective and preventative actions (CAPA) Complaint and recall handling Calibration and maintenance Qualification & validation Write and/or review GxP documents related to QC activities (e.g., SOPs, qualification/validation reports, and batch records) to ensure good documentation practices, data integrity, and regulatory compliance. Draft, review, and approve Quality and GxP-related documentation. Facilitate or perform risk assessments and investigations as required. Provide guidance to manufacturing and QC teams on Quality-related matters. Assess the quality and suitability of equipment, materials, and services for QC lab purposes. Monitor trends and the effectiveness of quality management systems, developing and producing KPIs and Quality Metrics. Inform Senior Management of significant quality-related matters or risks that could impact product quality, product release, or regulatory compliance. Organize and deliver QC-related training sessions. Provide general quality support for other business functions, including R&D, clinical trial sample testing, and process development teams. Act as a Subject Matter Expert (SME) for QC in alignment with relevant regulatory authority cGMP requirements. Follow current Good Manufacturing Practices (cGMP) in compliance with US, UK, EU, and other regulatory expectations. Recommend validation and qualification approaches, strategies, priorities, and resourcing needs for new projects or re-qualification cycles. Work within a matrix management structure, collaborating closely with internal and external teams, including suppliers and partners. Communicate and liaise with internal departments and external customers involved in qualification and validation activities to ensure efficiency and compliance with regulatory standards. If you are interested, then please apply with an up-to-date copy of your CV and I will be in touch shortly. Thanks Seniority level Mid-Senior level Employment type Full-time Job function Science #J-18808-Ljbffr
Senior Quality Control Scientist employer: Northreach
Contact Detail:
Northreach Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Quality Control Scientist
✨Tip Number 1
Familiarize yourself with the latest regulations and guidelines related to GMP, GCP, and ATMPs. This knowledge will not only help you in interviews but also demonstrate your commitment to quality control in the cell therapy field.
✨Tip Number 2
Network with professionals in the quality control and cell therapy sectors. Attend industry conferences or webinars to connect with potential colleagues and learn about the latest trends and challenges in the field.
✨Tip Number 3
Prepare to discuss specific examples of how you've managed QC duties in previous roles. Highlight your experience with CAPA, deviation reporting, and risk assessments to showcase your expertise.
✨Tip Number 4
Stay updated on the latest advancements in cellular therapies and their regulatory requirements. Being knowledgeable about current developments will set you apart as a candidate who is proactive and engaged in the field.
We think you need these skills to ace Senior Quality Control Scientist
Some tips for your application 🫡
Understand the Role: Take the time to thoroughly read the job description for the Senior Quality Control Scientist position. Understand the key responsibilities and required qualifications to tailor your application accordingly.
Highlight Relevant Experience: In your CV and cover letter, emphasize your experience with GMP, GCP, and other regulatory requirements. Provide specific examples of how you've managed QC duties or contributed to quality management systems in previous roles.
Showcase Your Skills: Make sure to highlight your skills related to document control, CAPA, deviation reporting, and training. Mention any experience you have with writing or reviewing GxP documents, as this is crucial for the role.
Tailor Your Application: Customize your CV and cover letter to reflect the language and requirements mentioned in the job description. Use keywords from the listing to demonstrate that you are a perfect fit for the position.
How to prepare for a job interview at Northreach
✨Understand GMP and GxP Regulations
Make sure you have a solid understanding of Good Manufacturing Practices (GMP) and Good Practice (GxP) regulations. Be prepared to discuss how these regulations impact quality control processes and your previous experiences in ensuring compliance.
✨Showcase Your QC Experience
Highlight your experience with quality control duties, especially in the context of cellular therapies and ATMPs. Be ready to provide specific examples of how you've managed documentation, change controls, and CAPA in past roles.
✨Demonstrate Problem-Solving Skills
Prepare to discuss how you've handled deviations, out-of-specification (OOS) results, and complaints in your previous positions. Employers will be looking for your ability to assess risks and implement effective corrective actions.
✨Emphasize Team Collaboration
Since this role involves working within a matrix management structure, be ready to talk about your experience collaborating with cross-functional teams. Share examples of how you've effectively communicated quality-related matters to both internal departments and external partners.
