Boston Scientific Laboratory Tech - S1 

United Kingdom, England, Waverley 

438189571

United Kingdom-Farnham

Broad Function

The role provides microbiological and analytical testing support for pharmaceutical products manufactured at the Farnham site. Following BSCI Quality Standards or Pharmacopoeia methods, testing will cover water sampling & testing, environmental monitoring of cleanrooms & testing of in-process samples and finished products. The job holder will be required to document work in a compliant manner, with good attention to detail and good documentation practice. Daily entry into cleanroom environments is expected.

Principal Responsibilities

1. To ensure that departmental objectives are executed in line with the overall Quality/Corporate goals.
2. To comply with all safety and GMP requirements within the Laboratory and Cleanrooms.
3. To execute analytical testing for microbiology requirements to support any QC, R&D or Manufacturing activity. Routine activities include bioburden testing, endotoxin testing, Analytical testing of water samples (TOC and Conductivity), environmental monitoring (Active air, settle plate, contact plate & non-viable particles)
4. To ensure preparation and timely submission of test samples to external test houses.
5. Where required working to Standard Operating Procedures/WIs, complete the environmental sampling of cleanroom environments.
6. Ensure documentation of all testing activities to current BSCI and regulatory standards.
7. To liaise with all external contract testing laboratories.
8. Input of data to support Key Performance Indicators (KPI) and trending.
9. Participate in multi-functional teams to support project assignments.
10. Interact with the electronic QMS, initiating quality event investigations, updating documents
11. Author reports to support product release and analysing environmental trends
12. Own & manage a QC Microbiology process to ensure compliance to calibration and maintenance requirements
13. Ensure that all interactions and engagements are carried out with the highest ethical and professional standards and that all work is accomplished with quality and in accordance with BTG values.
14. Complete additional tasks considered necessary to meet business and customer requirements as indicated by the Line Manager.

The above duties and responsibilities are not an exhaustive list and you may be required to undertake any other reasonable duties compatible with your experience and competencies. This description may be varied from time to time to reflect changing business requirements.

Principal Relationships

1. 1. Accountable to – QC Microbiologist Lead, Microbiology Team Laboratory
   2. Internal – Manufacturing, warehouse, engineering and QA
   3. External – Test Houses

Education and Experience required

1. Educated to BSC (minimum) in Microbiology, applied biology or a related discipline.
2. Experience with environmental monitoring of cleanrooms preferred
3. Experience in bioburden and endotoxin testing preferred
4. Experience of working to GMP and to Good Documentation practice

Skills and Attributes required

1. To demonstrate computer skills – Microsoft Office preferred.
2. Good written and verbal skills, to enable communication of technical information in a concise manner.
3. To complete assignments in a timely manner and communicate progress at intervals.
4. To analytically evaluate results.
5. Be a self-starter capable of working on their own and under supervision
6. Must be a team player and be able to interact with colleagues in a constructive and positive manner.
7. Ability to manage changing priorities