QC Scientist - Chemistry

Cardiff and Vale University Health Board; Seaton Delaval; On-site; GBP 70,000 - 100,000; Full time

Job summary

Medicines Manufacturing Centre (MMC) in Seaton Delaval, Northumberland, part of the NHS, seeks a Senior QC Scientist - Chemistry to lead quality control across in-process, finished product, and aseptic testing. You will manage QC scientists/technicians, ensure GMP compliance, and collaborate with the Head of Quality Control during MHRA inspections.

The role requires postgraduate analytical chemistry or pharmaceutical analysis, strong leadership, QA knowledge, and experience with LIMS and CAPA.

Qualifications

• Degree in chemistry or pharmacy with GMP knowledge.
• Postgraduate qualification in analytical chemistry or QA/GMP.
• Experience in QC lab leadership and documentation.
• Familiarity with LIMS and CAPA processes.

Responsibilities

• Lead QC chemistry testing for in-process, finished product, and container/closure analyses.
• Manage QC testing of raw materials, CPCs, and samples per pharmacopoeia.
• Oversee QC documentation, SOPs, worksheets, and QC reports.
• Lead PQS for QC, manage deviations, CAPA, change control, and data integrity.

Skills

GMP compliance

Analytical testing

In-process testing

Finished product testing

Sampling plans

LIMS data handling

QC leadership

QA systems

Document management

Statistical analysis

Education

Degree in Chemistry or Pharmacy

Postgraduate qualification in Analytical Chemistry / Pharmaceutical Analysis

Postgraduate qualification in Quality Assurance / GMP

Management qualification

Tools

LIMS

MS Office

Job description

An exciting opportunity has arisen for a proactive and passionate Senior QC Scientist - Chemistry 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. 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.,

• To support the delivery of a GMP compliant manufacturing facility that optimises the regional benefit from the £30 million funding provided by NHSE.
• Provides technical QC advice and support to ensure GMP compliance within the MMC. This includes supporting the Head of Quality Control within MHRA inspections, which are essential for continuity of the MMCs manufacturing licence.
• Responsible for managing the Quality Control chemistry Scientist / Technicians.
• Responsible for the management of designated teams that manufacture unlicensed medicines to the value of approximately £20 million per annum., Day to day and training of Quality Control (QC) Scientists / Technicians.
• Lead and perform QC chemistry testing including In-process testing, Finished product testing, Container/closure tests and QC sample analysis.
• Manage QC chemistry testing - raw materials (RM), consumables/ packaging/ components (CPCs), in process testing, finished products in compliance with the pharmacopoeia and any other samples (e.g. filters, water samples), including appropriate sampling plans.
• Release raw materials and CPC for use in production of aseptic medicines.
• Contribute to the MMC facilitys strategy to cleaning validation including managing residue testing.
• Manage filter integrity testing for production processes.
• Develop stability test plans in agreed with ICHQ1 and perform stability and ongoing stability tests, ensuring appropriate sample management.
• Collaborate with the QC Lab Manager to obtain required documents for supplier approval of raw materials and CPCs.
• Manage QC documentation, including SOPs, worksheets, and QC reports.
• Oversee QC equipment qualification, calibration, repairs and servicing.
• Support QC validation scientists as directed with new analytical methods.
• Ensure appropriate management, validation, and storage of QC reference standards, reference samples, and retention samples.
• Manage lab stocks including reagents and implement an expiry monitoring plan.
• Act as Pharmaceutical Quality System (PQS) lead for QC, including ensuring QC data integrity, leading QC deviations and Out-of-Specification (OOS) investigations, managing change control processes (QC assessment) and implementing Corrective and Preventative Actions (CAPA).
• Maintain accurate QC data recording, trending, and statistical analysis, including use of lab databases (e.g. LIMS), sample management, and labelling.
• To role model compassionate and inclusive leadership in order to shape the creation of a collective leadership culture within the trust. This means demonstrating a consistent leadership style which (a) engages, enables and empowers others (b) uses coaching to promote ownership of learning and quality improvement and (c) facilitates team working and collaboration within teams / departments and across organisational boundaries. Degree in relevant scientific discipline e.g. chemistry, pharmacy., Professional Registration.
• Post graduate qualification in Analytical Chemistry / Pharmaceutical Analysis.
• Post graduate qualification in Quality Assurance / GMP.
• Management Qualification. Post qualification experience in the analytical techniques used in pharmaceutical quality control as per British Pharmacopoeia requirements.
• Knowledge and experience in implementing laboratory safety requirements. e.g. COSHH. Experience of using Quality Management Systems, including, leading out-of-specification investigation, root cause analysis tools, change controls, document management.
• Experience in QC testing requirements of sterile medicines as per Annex 1.
• Experience in line management.
• Knowledge of or experience in coaching and mentoring practices and tools. 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