Quality Specialist

LGC Group; Oxford; On-site; GBP 35,000 - 45,000; Full time

Job summary

A leading quality assurance firm in Oxford is seeking a Quality Specialist to enhance and maintain ISO 9001 quality systems and ensure compliance with international regulations. The role involves conducting audits, supporting quality processes, and driving continuous improvement in manufacturing standards. Candidates should possess a degree in a related field and at least 3 years of experience in quality assurance, preferably in the medical or pharmaceutical industries. This full-time position requires strong attention to detail and excellent interpersonal skills.

Qualifications

• 3+ years of experience in a quality function, preferably in medical devices or pharmaceuticals.
• Detailed understanding of ISO 9001 and international regulatory requirements.
• Familiarity with ISO 13485 and ISO 14971.

Responsibilities

• Enhance and maintain ISO 9001 quality system.
• Support QMS processes including CAPA, NCR, and Deviation.
• Perform and coordinate internal and supplier quality audits.

Skills

Quality Assurance

FDA Regulations

Data Collection

Food Safety Experience

ISO 9001

Mobile Devices

Root cause Analysis

Quality Systems

OSHA

Food Processing

Quality Management

cGMP

Education

Degree in Science / Engineering / QA or a related field

Job description

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 companys 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 LGCs 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

• Degree 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.

Remote Work

No

Employment Type

Full-time

Key Skills

• Quality Assurance
• FDA Regulations
• Data Collection
• Food Safety Experience
• ISO 9001
• Mobile Devices
• Root cause Analysis
• Quality Systems
• OSHA
• Food Processing
• Quality Management
• cGMP

Experience

years

Vacancy

1