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Quality Control Scientist

Quality Control (QC) Laboratories carry out a number of highly specialist activities such as:

• Analytical testing
• Cleaning validation
• Environmental monitoring
• Formulation and stability studies
• Medical gas testing

Young scientist watching laboratory machine during an experiment

What are NHS Technical Services

Technical services within the NHS are made up of the following services:

  • Aseptic Units: Carry out preparation and dispensing of patient-specific sterile medicines, including chemotherapy, parenteral nutrition (PN), central intravenous additive services (CIVAS) and clinical trials.
  • Production / Manufacturing Units: Carry out the manufacture of batches of medicines, including but not limited to chemotherapy, parenteral nutrition (PN) and central intravenous additive services (CIVAS), clinical trials and gene therapy.
  • Radiopharmacy: Carry out manufacturing and supplying radioactive substances used in nuclear medicine.
  • Quality Assurance (QA): Are responsible for ensuring that the final products conform to the appropriate quality. They are responsible for the creation and maintenance of the quality system used within technical services and are involved with the assessment of the quality of unlicensed medicines.
  • Quality Control (QC): Carry out a range of chemical and microbiological tests on medicines and materials to ensure they are safe to use.

Within the NHS, aseptic units and production units are required to carry out routine chemical and microbiology testing. This is carried out by either a QC laboratory on-site or a contract QC laboratory.

QC laboratories help ensure that the products prepared or manufactured within NHS facilities are sterile, stable and fit for purpose.

What is the Role?

A QC scientist is responsible for performing analysis of the goods and products prepared by an aseptic unit or manufactured by a production unit.  They ensure that the quality of raw materials and consumables used are fit for purpose and will not cause harm to patients. As a QC Scientist, you will be required to work under the supervision and instruction of the Laboratory Manager or Head of Quality Control.

What would you do in the role?

  • Carry out testing according to the approved Standard Operating Procedures (SOP) for raw materials (ingredients) and finished products. You will be required to make a judgment of the validity of the results produced by taking into account all relevant factors.
  • To maintain laboratory stocks of chemicals and reagents.
  • To undertake the preparation of reagents and standards using a highly sensitive electronic balance, validated pipettes and Class A volumetric glassware.
  • Monitors temperature records to ensure excursions are reported and actioned immediately.
  • To carry out and document investigations including but not limited to out-of-specifications, deviations and change controls.
  • To be an active participant in the maintenance of the Quality Control laboratory Quality Management System.

QC laboratories are essential for ensuring that products prepared within an aseptic unit or production units are fit for purpose for several reasons such as:

  • They ensure that the environment in which the products are manufactured is of the correct pharmaceutical grade.
  • They carry out chemical stability studies on products to ensure that the products are fit for patient use.
  • They ensure that raw materials for products are fit for purpose and from an authorised supplier.

Within a QC laboratory, the team may consist of the following roles: QC Lab Manager, Site Microbiologist, Deputy QC Lab Manager, QC Supervisor, QC Validation Scientist, QC Scientist, QC Technician.

This sector is vital to ensuring patients receive fit-for-purpose products as aseptic and production units provide treatment to a range of complicated and clinically unwell patients.

If you want to make an impact on patients’ lives but do not want to engage in patient contact this role is for you.

Quality Control roles are great for those who enjoy science, maths and helping patients.

Responsibilities

  • To maintain laboratory stocks of chemicals and reagents.
  • To undertake the preparation of reagents and standards using a highly sensitive electronic balance, validated pipettes and Class A volumetric glassware.
  • To carry out and document investigations including but not limited to out-of-specifications, deviations and change controls.
  • To assist in the maintenance of the Quality Control laboratory Quality Management System
  • To undertake the sampling of booked in raw materials ready for QC testing.
  • To undertake testing of containers according to QC specifications and worksheets.
  • To carry out finished product stability testing.
  • To use environmental monitoring and other QC equipment correctly.
  • Responsible for the upkeep of equipment files and PPM database entries.
  • Collate test data and generate reports to be submitted to QC Lab Manager.
  • To ensure all GMP documentation is completed, stored, and maintained appropriately.

Skills

  • You must be able to demonstrate a high level of good manufacturing practice (GMP) and good laboratory practice (GLP).
  • You must have good communication skills, used within the delivery of training and regular quality meetings.
  • You must be able to demonstrate an ability to perform accurate and complex calculations.

Salary

A QC scientist working within the NHS is generally a band 5 or 6 level, this is dependent on designated responsibility.

Band 5: £28,407 – £34,581

Band 6: £35,392 – £42,618

(Based on 2023/2024 pay scales)

More information on the pay, pensions and rewards, can be found on the NHS Employers website.

Working hours

A QC scientist working in the NHS will generally work 37.5 a week.

The working models of each NHS organisation may vary therefore you may have to work the following models:

  • 9-5 Monday to Friday
  • Shift working
  • 7-day working

Employers

NHS Organisations.

Similar roles are available outside of the NHS within universities and commercial laboratories.

Work experience

Work experience in any area of the NHS would support you to access employment in your future career.

Asking to volunteer at a hospital at an early stage in your career is also of great benefit.

What to expect

While working in the laboratory you will work with equipment that includes high-performance liquid chromatography (HPLC), fourier-transform infrared spectroscopy (FTIR), auto titrators, pH meter, conductivity meter, refractometer, and melting point. These test methods are used to support product testing and carry out stability studies to support the expiry allocation of current products and also allocate expiries for new products.

An example of a high performance liquid chromatography (HPLC) that you may use in this role – see opposite.

Ultra high performance chromatography (HPLC)

Microbiology materials

You may also have to use microbiology materials such as settle plates, contact plates and other growth media.

When working within a Laboratory you will be required to wear a lab overcoat.

When working within the sterility testing cleanrooms you will be required to wear cleanroom clothing, hair nets, beard nets, gloves and occasionally masks. Staff are not allowed to wear makeup, false nails, false eyelashes, jewellery when working within the cleanrooms to maintain the strictly controlled environment to project the products and patients.

Female scientist researcher conducting an experiment in a lab

Career Progression

There are several career opportunities such as:

  • Senior Releasing Officer
  • Head of Quality
  • Head of QC
  • Qualified Person (QP)
  • Laboratory Manager
  • Quality Manager

Further training could also be gained in the form of:

  • MSc in Pharmacy Technology and Quality Assurance

A full range of roles can be found within the career escalator tool.

Routes to become a QC Scientist

To become a QC scientist within the NHS you will need to hold a degree or equivalent in a scientific subject (for example chemistry or pharmacy). You will be required to have experience within a laboratory setting and have a good working knowledge of organic, inorganic, and physical chemistry. You must have good knowledge of analytical techniques used within pharmaceutical quality control.

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