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™ 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.
Job DescriptionPosition 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.
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.
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
- BSc in Science, Engineering, QA, or related field
- Minimum 3 years practical experience in a quality function (medical device, pharmaceutical, biotechnology, or laboratory environment preferred)
- Detailed understanding of ISO 9001 and international regulatory requirements
- Familiarity with ISO 13485 and ISO 14971
- Experience with CAPA, NCR, and Deviation processes
- Experience performing internal audits and acting as site Lead Auditor
- Experience conducting supplier quality audits and supplier assessment
- Experience with Change Control and Documentation Control activities, including updating and approving SOPs, batch records, and quality records
- Ability to use quality tools to track and trend quality performance
- Strong attention to detail, communication skills, and ability to prioritise tasks
LGC Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about LGC and has not been reviewed or approved by LGC.
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Healthcare Strength — Health, dental, and vision coverage with FSA/HSA options are consistently part of the package, and private medical is cited where applicable in the UK. Coverage is often characterized as solid alongside other core benefits.
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Retirement Support — Retirement offerings include a 401(k) with employer contribution in the U.S. and pension schemes in the UK, complemented by life and disability insurance. These elements are highlighted as part of a standard-to-competitive core package.
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Leave & Time Off Breadth — Paid time off, holidays, sick leave, and family leave are broadly available, with some sites offering a year‑end shutdown. Flexibility and local leave programs contribute to a generally well-rounded time‑off offering.
LGC Insights
What We Do
LGC is a leading, global life science tools company, providing mission-critical components and solutions into high-growth application areas across the human healthcare and applied market segments. Its high quality product portfolio is comprised of mission-critical tools for genomic analysis and for quality assurance applications, which are typically embedded and recurring within our customers’ products and workflows and are valued for their performance, quality and range. LGC’s tools play a key role in customer workflows from discovery applications through to commercial manufacture and enable its customers to: bring new diagnostics and therapies to market; progress research and development; optimise food production; and continuously monitor and enhance the quality of food, the environment and consumer products. LGC’s 175+ years of scientific heritage, combined with a track record of innovation and value-enhancing acquisitions, has enabled the company to build its product portfolio and expertise, and develop deep relationships with customers, industry partners and the global scientific community. LGC’s core purpose of Science for a safer world and its core values of passion, curiosity, integrity, brilliance and respect, drive its culture. As of 30 June 2021, it employs 4,350 employees, of which over 1,175 employees hold PhD and/or master’s degrees. Its products and services are delivered by highly qualified and experienced teams, operating from a global network of accredited sites that showcase its scientific and manufacturing capabilities.
