Job Description

Company Description
Join our dynamic team at The Native Antigen Company as a Senior 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(TM) 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.

Position Summary
The Quality Specialist will join our dynamic team at LGC in Oxford, UK. This opportunity is truly special as it allows you to play a vital role in ensuring that our manufacturing processes meet world-class standards. You will be crucial in upholding and enhancing our ISO 9001 quality systems, ensuring flawless execution and compliance with international regulations. Your contributions will enable us to consistently provide outstanding products and services!
Duties:

• Carry out, sustain, and consistently enhance the implemented quality system (ISO 9001) at The Native Antigen Company (TNAC).
• Support all QMS processes, including CAPA, NCR, and Deviation processes, by liaising with impacted areas to ensure timely and effective implementation and prevention of re-occurrences.
• Coordinate, complete, and assist in the auditing program by performing internal audits and supplier quality audits as the site Lead Auditor.
• Support and participate in external audits (Notified Body Audit, Customer Audits, etc.)
• Assist in conducting Management Reviews for the Native Antigen Company, including follow-ups on identified actions.
• Monitor existing suppliers/distributors and assess the suitability of new suppliers/distributors in accordance with the established quality system requirements.
• Provide support to Change Controls and Documentation Control activities.
• Update, review, and approve quality documentation such as SOPs, Batch Production Records, Quality records, etc
• Utilise quality tools to track and trend quality performance, identifying key opportunities for improvement.
• Operate within the company's standard operating procedures and review, maintain, and build appropriate procedures.
• Maintain a good level of housekeeping in designated areas and observe all Health and Safety at work requirements.
• Perform other related duties as required to support TNAC Quality Systems.

Behavioural & Interpersonal Proficiencies:

• Resonate and operate in line with LGC's core value behaviours: Passion, Curiosity, Integrity, Brilliance, and Respect.
• Promote cooperation and dedication within a team to achieve goals and deliverables.
• Demonstrate strong initiative and troubleshooting skills.
• Exhibit strong interpersonal skills and the ability to communicate effectively - verbally and in writing - with others.
• Show excellent attention to detail and ability to prioritise tasks.

Work Conditions

• Travel & Time Expectations: This position may require working evening or weekend hours in support of business and customer needs.
• Work Setting: Primarily an office setting with manufacturing exposure; home-based work environment possible, dependent on business needs.
• Distinctive Safety Conditions: Exposure to hazards or physical risks, such as hazardous materials and noise levels, which require particular safety precautions and specific occupational training.
• Required Personal Protective Equipment (PPE): lab jacket, safety shoes, hearing or eye protection.

Qualifications
Essential Knowledge & Qualifications:

• B.Sc. in Science/Engineering/QA or a related field.
• A minimum of 3 years practical experience (or equivalent) in a quality function, ideally gained in a medical device, pharmaceutical, biotechnology, or laboratory environment.
• Detailed understanding of ISO 9001 and international regulatory requirements.
• Familiarity with ISO 13485 and ISO 14971.

Additional Information
Physical Demands
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.

Work Environment
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.

Skills Required