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Northumbria Healthcare - NHCT Northumbria Healthcare NHS Foundation Trust

About
Northumbria Healthcare NHS Foundation Trust is an award winning NHS Foundation Trust which provides hospital and community health services in North Tyneside, and hospital, community health and adult social care services in Northumberland.
Contact
- Address
- Northumbria Healthcare NHS Foundation Trust
- Human Resources Department
- Northumbria House
- 7/8 Silver Fox Way, Cobalt Business Park
- Newcastle upon Tyne
- NE27 0QJ
- Contact Number
- 0191 2031415 Option 2
Quality Control Lead Scientist Microbiology
Accepting applications until: 22-May-2025 23:59
Vacancy status: Open
Accepting applications until: 22-May-2025 23:59
Key details
Location
- Site
- Manufacturing and Innovation Hub
- Address
- Avenue Road
- Town
- Seaton Delaval
- Postcode
- NE25 0QJ
- Major / Minor Region
- Tyne and Wear
Contract type & working pattern
- Contract
- Permanent
- Hours
- Full time
- Flexible working
- Compressed hours
Salary
- Salary
- £46,148 - £52,809 per annum
- Salary period
- Yearly
- Grade
- (NHS AfC: Band 7)
Specialty
- Main area
- Medicines Manufacturing Centre - Research and Development
Do you want to work in one of the best performing NHS organisations in England? Work for an organisation that was voted the best acute and combined acute and community trust in the country, based on the experience of its staff (NHS Staff Survey 2022). Work in an organisation that supports its staff and focuses on staff experience as much as it does the experience of its patients? You can live and breathe in an area that has the cleanest air, cost effective living, great nightlife, some of the best schools with a wealth of history available on your doorstep. Sound too good to be true? Well it isn’t, this is what you get when you work for Northumbria Healthcare and, this is…the Northumbria Way!
What the Northumbria Way means for you:
- Extensive staff health and well-being programme including access to our specialist Wellbeing Hub
- Support and connection through a variety of Staff Network groups
- A range of flexible working opportunities
- Generous annual leave and pension scheme
- Access to lease car and home electronics scheme (qualifying criteria applies)
- Opportunities to improve your professional development through our vast training programmes
- On-site nursery places via salary sacrifice
- Access to savings scheme via salary sacrifice with Northumberland Community Bank
We are proud to be one of the country’s top performing NHS trusts – rated ‘outstanding’ overall by the Care Quality Commission (CQC). We provide a range of health and care services to support more than 500,000 people living in Northumberland and North Tyneside across the largest geographical area of any NHS Trust in England. Our teams deliver care from hospitals, a range of community venues and people’s homes. Our hospitals include a specialist emergency care hospital (the first of its kind in England), three general hospitals and community hospitals. In the community we deliver a wide range of community and public health services.
We lead in innovation and quality, having opened the Northumbria Healthcare Manufacturing and Innovation Hub during the Covid-19 pandemic and have recently launched our Community Promise – a pledge to make a real impact not just in healthcare but on the wider factors that affect people’s lives, such as education, employment and the economy.
If Northumbria Healthcare sounds like somewhere you could belong we would love to hear from you. Visit our website to catch up on our latest news.
Whilst Northumbria Healthcare are a highly innovative organisation, the use of Third Party Artificial Intelligence (AI) presents a risk to the integrity of our Recruitment & Selection processes. If you use AI, and it poses a risk to the integrity your individual recruitment process, we may withdraw your application at any stage of the process.
Job overview
An exciting opportunity has arisen for a proactive and passionate Quality Control Lead Scientist Microbiology to join the Medicines Manufacturing Centre (MMC)—a cutting-edge NHS pharmaceutical production facility based in Seaton Delaval, Northumberland. The MMC is in its final design stages, with facility construction planned through to September 2025. This is a fantastic opportunity to be part of a pioneering NHS manufacturing facility, supporting a leadership team committed to quality, innovation, and patient care. Please note we reserve the right to close this vacancy prior to the closing date once the required number of suitable applications have been received.
All employees of the Medicine Manufacturing Centre (MMC) are currently employed by Northumbria Healthcare NHS Foundation Trust, under Agenda for Change Terms and Conditions. Should the service be transferred into alternative ownership, those employees with start dates prior to the transfer date, will be protected under Transfer of Undertakings (Protection of Employment) Regulations 2006 (TUPE). Therefore, employees will transfer to the new employer on the same terms and conditions, which are protected and the employees’ continuity of employment is preserved
Please note we reserve the right to close this vacancy prior to the closing date once the required number of suitable applications have been received.
Advert
Oversee the New Product Introduction (NPI) processes from a Microbiology QC perspective, ensuring successful implementation for products to be manufactured in the Medicines Manufacturing Centre (MMC). This includes:
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Method development
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Analytical method validation
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Technology/method transfer
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Reference standards management
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Sampling and QC stability testing
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Ongoing stability studies
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Supervise QC Microbiology testing for:
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Components and packaging
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Raw materials
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In-process testing
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Finished products
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Environmental monitoring samples
Implement QC Microbiology policies and processes that comply with Good Manufacturing Practice (GMP) and data integrity requirements.
Oversee and manage QC Microbiology documentation, ensuring all records are up to date and comply with regulatory requirements.
Lead training for QC Microbiology staff, ensuring they are proficient in relevant QC methods and regulatory standards.
Prepare and implement QC microbiology documentation such as:
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Worksheets, SOPs, and stability plans
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QC reports
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Statistical analysis
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Perform assessments for the Pharmaceutical Quality System (PQS), including:
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Out of Specification (OOS) investigations
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Root Cause Analysis (RCA)
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Quality Risk Assessment (QRA)
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QC assessment on Change Control
Perform QC data recording, trending, and statistical analysis for QC microbiology data, and track Key Performance Indicators (KPIs).
Working for our organisation
The Medicines Manufacturing Centre (MMC) is a brand-new, purpose-built NHS pharmaceutical production facility located at the Northumbria Innovation and Manufacturing Hub in Seaton Delaval, Northumberland. This cutting-edge centre is part of the North East and North Cumbria Provider Collaborative and has been established to meet the growing need for high-quality, regionally manufactured Ready-to-Administer (RtA) medicines and advanced aseptic products.
Funded with £30 million of investment from NHS England, the MMC will support a secure, sustainable supply chain for critical medicines, particularly for oncology and other high-risk therapies, while creating skilled jobs and driving innovation across the region. The facility is designed to operate under a Manufacturer’s Specials Licence (MS) and aims to secure a Wholesale Dealer’s Authorisation (WDA(H)), ensuring compliance with MHRA, GMP, and GDP regulations from day one.
At the MMC, quality, patient safety, and staff wellbeing are at the heart of everything we do. Our leadership team is committed to building a culture of openness, learning, and continuous improvement—offering staff a rare opportunity to help shape the systems, teams, and values of a truly modern NHS manufacturing unit.
Working at the MMC means being part of a forward-thinking and supportive team focused on enabling frontline clinical staff to spend more time with patients by delivering safe, ready-to-use medicines.
Detailed job description and main responsibilities
Support the implementation of stability studies and ongoing stability testing programs, as well as investigational work and validations.
Ensure that analysis on raw materials, packaging components, and finished pharmaceutical products is carried out in line with approved QC worksheets and SOPs.
Oversee the supplier approval process and manage incoming goods checks and testing.
Develop and manage processes for the Microbiology QC Lab and sterility suite, including workload management and resource allocation.
Manage a team of Microbiology Quality Control Scientists, ensuring their development and performance within the laboratory.
Ensure that all QC microbiology equipment is properly qualified and serviced, including managing contractors for outsourced activities.
Demonstrate compassionate and inclusive leadership, contributing to the creation of a collective leadership culture within the Trust by:
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Engaging, enabling, and empowering others
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Using coaching to promote ownership of learning and quality improvement
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Facilitating team working and collaboration across teams, departments, and organisational boundaries
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Applicants who are members of the Armed Forces, and those who have a disability that requires support in the work place (two ticks pledge) and who meet the essential criteria will be interviewed under the Trust's interview guarantee scheme.
We recognise the positive value of diversity and inclusion and are committed to a workforce that is diverse, equal and inclusive. We welcome and encourage job applications from people of all backgrounds. We particularly welcome applications from Black, Asian and Minority Ethnic (BAME) candidates as BAME people are currently under-represented in our workforce as well as other under-represented groups such as LGBT+ and disabled candidates. We are proud to be a Disability Confident Employer, a Stonewall Diversity Champion, we have a Gold award from the Defense Recognition Scheme, and we are delighted to support Apprenticeships, Age Posi+ive and are a mindful employer.
If you require any reasonable adjustments to attend interview please make the recruitment team aware as soon as possible by calling our HR Recruitment Team on 0191 203 1415 option 2.
Applicants who meet the Fit and Proper Person Requirements (FPPR) will require additional pre-employment checks in line with CQC and NHS England statutory guidance.
Make sure to read the ‘applicant guidance notes’ before submitting your application and make sure you know everything there is to know before joining our fantastic trust!
Certificate of Sponsorship
Northumbria Healthcare NHS Foundation Trust proudly hold a sponsor licence. In order to provide sponsorship you and the role you are applying for must meet UKVI eligibility requirements. Please check your eligibility prior to submitting an application. Skilled Worker visa: Overview - GOV.UK (www.gov.uk)
Please note that it is a requirement of this Trust that all successful applicants pay for their own DBS certification if a DBS check is required for the post. The method of payment is a salary deduction from your first monthly pay.
Applicant requirements
Person specification
Qualifications
Essential criteria
- Degree in relevant scientific discipline or equivalent experience.
- Eligible to be Registered Professional with the General Pharmaceutical Council (GPhC), Health and Care Professions Council HCPC, Royal Society for Chemistry (RSC) or Royal Society for Biology (RSB), or Royal Pharmaceutical Society (RPS).
Desirable criteria
- Professional Registration
- Post graduate qualification in Pharmaceutical Microbiology / pharmaceutical science
- Post graduate qualification in Quality Assurance / GMP
Experience
Essential criteria
- Knowledge of EU Good Manufacturing Practice, including Annex 1
- Demonstrated knowledge of pharmaceutical microbiology and its application in a GMP environment
- Strong technical and analytical skills, with expertise in system risk assessments and validation
- Experience of microbiology testing techniques as per British Pharmacopoeia requirements and qualification of these methods e.g. ID testing, sterility testing, growth promotion, bioburden
- Knowledge in the qualification, use and maintenance of laboratory instruments
- Knowledge in trending and statistical analysis of data.
- Knowledge and experience in implementing laboratory safety requirements. e.g. COSHH.
Desirable criteria
- Experience of New Production Introduction management from a Quality Control Perspective
- Experience of using Pharmaceutical Quality Systems, including, leading out-of-specification investigation, root cause analysis tools, change controls, document management
- Experience in QC micro testing requirements of sterile medicines, in alignment with pharmacopeial requirements and formulation requirements.
- Awareness of developments in technical areas of Pharmaceutical Manufacture.
- Experience of managing a team
- Experience of managing a laboratory
- Knowledge of or experience in coaching and mentoring practices and tools.
- Knowledge of or experience in Quality improvement tools, techniques and methods.
Further details / informal visits contact
- Name
- Carly McGurty
- Job title
- Deputy Head of Quality
- Email address
- [email protected]
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