(AfC band 3 equivalent)

Main Duties/Responsibilities:

The following apply either to all workstreams if a small Section 10 unit or to a specific workstream if a large Section 10 unit or licensed*1

Microbial Testing & Analysis

1. Responsible for incubating and reading micro samples (TVC)
2. Perform sterility testing
3. Media growth promotion
4. Carry out micro ID (Gram testing)
5. Perform Handwash water microbiological testing
6. Process micro monitoring samples (book in, incubate, read, basic colony identification, send for ID if external lab used)

Environmental Monitoring (EM) & Equipment Validation

1. Carry out and report physical and micro environmental monitoring (EM) under supervision
2. Checking equipment (pre-tests)
3. Support management and calibrations of equipment (i.e. scales), i.e. sending equipment for calibration
4. Carry out temperature mapping and downloading data
5. Checking temperature monitoring system

Testing & Quality Control

1. Basic/less critical testing (i.e. pH, some raw material testing, IR)
2. Support in-process testing (i.e. pH, sampling, etc.)
3. Preparing stock solutions

PQS & Quality Management

1. Participate in supporting tasks related to the maintenance of the PQS (or ePQS)/PQS processes, such as completion of documentation as required
2. Deviation reporting
3. Error reporting

Supervision, Training & Development

1. Supporting delivery of operational training

Stock & Inventory Management

1. Receive requests for clearance kits
2. Assemble/issue PST kits
3. Stock checks

Customer & Stakeholder Interaction

1. Liaising with senior staff for out of spec results

Operational & Miscellaneous

1. Admin tasks: filing/archiving
2. Input of data in electronic systems
3. Waste management - Dispose of waste materials appropriately

Medical Gases Management (MGPS)

• (No tasks provided for this category)

Leadership & Service Management

• (No tasks provided for this category)

Requirements for applying to role:

• Ability to understand Basic English (written and spoken) and Maths.
• RQF Level 2 Qualification(s) (for example GCSE grade 4/C or above) in Maths and English (or equivalent) - desirable (≥ 4/C)*
• Any scientific assistant qualification (L2 (lab sciences)) - desirable

Considerations:

• Organisations should support the employee to achieve the required qualifications (e.g. GCSE level 4 equivalent qualification in Maths, English and Science/functional skills if not already held).

*Effective entry level role into the Production pathway should be an AFC B3 equivalent. However, having AfC B2 roles within organisations may still be appropriate for roles focused on repetitive lower-risk activities or limited scopes of tasks (e.g. storekeeper, licensed overlabelling).