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B. Quality Assurance/Control Technician

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Role description

Agenda for Change (AfC) Band 4 equivalent
Pay scales for 2026/27 | NHS Employers

Main Duties and Responsibilities:

The following apply either across all workstreams within smaller Section 10 units or to a specific workstream within larger Section 10 units or licensed services.*1

Microbial Testing & Analysis

  • Perform detailed morphological analysis of microbiological culture plates
  • Undertake microbiological identification techniques, including Gram staining, microscopy, MALDI-ToF analysis, and organism speciation using API kits or equivalent methods
  • Carry out media fertility testing in accordance with established procedures

Environmental Monitoring and Equipment Validation

  • Perform routine and non-routine cleanroom environmental testing and validation activities
  • Undertake routine and non-routine testing and validation of cleanroom equipment
  • Ensure environmental monitoring (EM) programmes are delivered in line with schedules and specifications
  • Deliver training in EM, temperature monitoring and mapping, and microbiological validation
  • Prepare EM specifications and documentation
  • Review and approve EM test results, initiating corrective actions where required
  • Draft, review and update standard operating procedures (SOPs), manuals, and master documents relating to EM, quality control and assurance, temperature monitoring, and microbiological validation
  • Interpret temperature monitoring data and prepare temperature mapping reports

Testing and Quality Control

  • Perform chemical and analytical assays consistent with those undertaken at Band 3 level, with increased responsibility and autonomy
  • Verify equipment suitability prior to use and ensure completion of pre-use checks
  • Undertake quality control checks of packaging materials and components
  • Prepare chemical testing reports (excluding high-complexity techniques such as HPLC)

 Pharmaceutical Quality System and Quality Management

  • Support out-of-specification (OOS) investigations, including data gathering and documentation
  • Contribute to the maintenance of the Pharmaceutical Quality System (PQS or ePQS), including completion of documentation and support for investigations
  • Initiate deviation reports in accordance with procedures
  • Record and report errors to support quality improvement processes
  • Support the implementation of change management within the cleanroom environment

Supervision, Training and Development

  • Deliver training in environmental monitoring, temperature monitoring and mapping, and microbiological validation to internal and external stakeholders
  • Support supervision of junior staff, including providing constructive feedback on performance
  • Escalate personnel and operational issues to senior staff as appropriate
  • Delegate tasks effectively within the team

Stock and Inventory Management

  • Raise and receipt purchase orders using electronic systems
  • Support day-to-day stock management activities
  • Issue Process Simulation Test (PST) kits
  • Review and approve requests for clearance kits

Customer and Stakeholder Interaction

  • Act as a first point of contact for complaints and service-related queries
  • Identify and escalate issues relating to defective medicines to appropriate stakeholders

 Operational and Administrative Duties

  • Issue cleaning and transfer disinfection documentation
  • Undertake checks on pre-packaged items
  • Maintain awareness of health and safety risks associated with the role and work environment

Medical Gases Pipeline Systems (MGPS)

  • No specific tasks identified within this category at present

 Leadership & Service Management

  • No specific tasks identified within this category at present

Qualifications

Essential requirements:

  • Demonstrable Good Manufacturing Practice (GMP) knowledge and experience at Level 3 equivalent; or
  • Level 3 qualification in Pharmacy or Science Manufacturing Technician (SMT); or
  • Degree in an applied science subject (BSc) with underpinning analytical laboratory skills and GMP understanding
  • Well-founded GMP experience and understanding (Level 3 equivalent) or L3 qualification (Pharmacy or SMT) or Applied Science degree (BSc) (for the basic analytical lab skills with GMP understanding
  • Knowledge of Good Clinical Laboratory Practice (GCLP), particularly relevant for quality control roles

Desirable:

  • Basic leadership qualification or willingness to undertake this during the probationary period

Related case studies for this role

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Quality Technician, King's College Hospital NHS Foundation Trust

Improving quality systems to deliver safer medicines and better patient outcomes.

Read transcript

Further information

Considerations:

The scope and level of responsibility may vary depending on the service size, specialism and organisational structure

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