Quality Specialist - FTC
- Department: Quality Assurance and Regulatory Affairs
Join our dynamic team at The Native Antigen Company for a maternity cover contract as a Quality Specialist. Located in Kidlington, UK, our company is a pioneer in developing and manufacturing premium-quality antigens and antibodies. With our cutting-edge VirtuE™ expression system, we play a crucial role in supporting the diagnostic and biopharmaceutical industries. In this role, you will be instrumental in maintaining the highest standards of product quality and upholding our Quality Management System processes.
As a Quality Specialist, your responsibilities include providing guidance to the team in executing and adhering to our Quality Management System. Effective communication with the Senior Quality Specialist and site leadership is key to addressing quality issues promptly. You will be responsible for training new employees and ensuring accurate training records. Additionally, you'll review and approve product records, ensuring compliance with internal and customer specifications. Managing QMS records related to nonconformance, deviations, and CAPAs will be part of your role, as well as overseeing protocols, reports, and change management documents.
Utilizing quality tools for tracking and improving performance, investigating quality issues, identifying root causes, and implementing corrective and preventive actions are essential tasks. You'll also play a crucial role in product release activities, including the review of labels, batch records, and QC results. Processing and approving document change requests and conducting internal audits will be among your responsibilities.
At The Native Antigen Company, we are dedicated to making the world safer through science, and this maternity cover contract offers a unique opportunity to contribute to our mission. Join us in Kidlington, UK, and be part of our dynamic team. Apply now to make a significant impact on global health.
We are looking for someone with a continuous improvement mindset, impeccable attention to detail, and strong interpersonal and communication skills. As a Quality Specialist, you'll need to demonstrate our core values: Curiosity, Integrity, Brilliance, Respect, and Passion. A minimum of a Bachelor's degree in a relevant Science, Engineering, or QA discipline is required, along with at least 2 years of industry experience in a Quality Assurance role within a regulated environment (medical devices, pharmaceutical, or biotechnology). A working knowledge of ISO 9001 or equivalent Quality Management System principles is essential.
- Minimum of a Bachelor’s degree in a relevant Science, Engineering or QA discipline.
- Industry experience working in a Quality Assurance role in a regulated environment for medical devices, pharmaceutical, or biotechnology industry.
- Working knowledge of ISO 9001 or equivalent Quality Management System principles.
The physical demands are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Requires prolonged sitting and working at a computer monitor. Repetitive motion using a keyboard for long periods of time. May occasionally be required to lift and move material weighing up to 10 lbs.
The work environment characteristics are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Agreeable work environment typical of an open office setting with some exposure to noise from office machines.