Quality Assurance Associate

Oxoid Remel Microbiology; East Grinstead; On-site; GBP 28,000 - 38,000; Full time

Job summary

Oxoid Remel Microbiology East Grinstead site leads the way in Sensititre AST products with a strong focus on quality and regulatory compliance. You will join the Quality Assurance team to support product release and documentation within the ISO 13485:2016 framework and related regulatory requirements.

The role involves QA responsibilities, audits, CAPA investigations, supplier control, and data reporting. A microbiology degree and audit experience are desirable, along with excellent

Qualifications

• Degree in microbiology or related field.
• Experience in a QMS role, preferably within MDD/IVD.
• Experience with audits and regulatory compliance.
• Strong attention to detail and communication skills.
• Proficient in MS Office.

Responsibilities

• Approve and review manufacturing documentation and SOPs.
• Support internal audits and external regulatory requirements (ISO 13485:2016, FDA).
• Coordinate investigations of quality issues and CAPA activities.
• Assist in supplier control reviews and performance assessments.
• Maintain quality records and document control for product releases.

Skills

Audit experience

Attention to detail

Communication

Independent working

Education

Degree in microbiology/related field

Tools

MS Office

Job description

Joining our team, you'll play an active part in helping to deliver meaningful impact. AtOxoid Remel Microbiology, acquired from Thermo Fisher Scientific, we play a crucial role in accurate identification and targeted treatment for diseases, ensuring food and beverage safety, and supporting pharmaceutical manufacturing integrity. Our products and services are designed to meet the highest standards of quality and performance, helping our customers achieve their objectives efficiently and effectively.

About the Role

Our MBD East Grinstead facility is at the forefront of our quest to keep Antibiotics effective and relevant for today’s results-oriented environments. The East Grinstead site is the only manufacturer of the Sensititre range of AST products, critical in the fight against primary infections and Covid 19 secondary infections. These vital products enable healthcare professionals to make an accurate diagnosis and to prescribe the right amount of the required antibiotic.

Working with our East Grinstead Sensititre products, our customers save lives every day, and we help them to make the world healthier, cleaner and safer. What we do makes a difference!

Our Sensititre AST/ID products are used globally to determine which antibiotics a particular bacterium is sensitive or resistant to and help to ensure patients are given the most appropriate treatment. Sensititre products can be used in Clinical, Pharmaceutical and Veterinary settings.

Playing a key role in our Site Mission is the Quality Assurance team, who ensure that all medical devices manufactured on site are compliant to the Quality Management System as per ISO 13485:2016. This team is both dynamic and diverse, with plenty of scope for development and progression within the structure.

This is a huge opportunity to learn from the best, develop as a quality professional and fulfill your true potential. You will be part of a team who are a key interface across the various areas on site. Working within this team you will ensure product release and documentation for the QMS is maintained as part of document control and control of records. The position requires a proficient communication and IT skills to support the site on the day-to-day administration of key quality tasks such as batch release and new product approvals.

What You’ll Do:

• Ensure that general day to day activities such as approval of manufacturing documentation including technical reports, review/approval of non-conformances, deviations, reviewer/approver for SOP's, briefs, software, specifications and forms
• Ensure compliance and assist in the audits (pre audit and post audit follow up to external (regulatory) requirements, including Quality Management Systems (ISO 13485:2016, FDA, CMDCAS) and the relevant requirements.
• Responsible for reviewing and approving SOP’s in line with change process.
• Co-ordinate investigation of customer complaints and general quality advice to the business.
• Undertake QA responsibilities regarding supplier control, review and performance.
• To act as coordinator and/or QA Representative on Corrective Action investigations.
• Perform internal audits to ensure compliance to external regulatory requirements.
• Assist in metric data for the Quality department.
• Assist in training for Quality functions and relevant documentation in up-to-date
• Any other duties/projects as are reasonable and within the skills and ability of the post-holder.

What We Are Looking For:

• Degree in microbiology/degree in a related field
• Confirmed experience in a QMS role preferably within MDD/IVD
• High attention to detail
• Ability to communicate openly
• Work flexibly to ensure targets are met
• Competent in the use of the MS Office suite
• Ability to work independently and in a group setting with little direction or direct supervision.
• Experience in audit involvement.
• Work flexibly to ensure deadlines are met
• Experience with writing concise/accurate and maintain reports/records

This is an exciting time to join us as we continue to build on more than 100 years of microbiology excellence. With a broad portfolio of instruments, services, and global resources, we’re steadfast in our commitment to helping you succeed. Together, we can cultivate a thriving microbiology culture that supports you today, tomorrow, and for life.

Come and be part of what’s next for our company.