Job summary
A new and exciting opportunity has arisen for an Environmental Monitoring Technician to work cross-site at the Guy's and St. Thomas' NHS Foundation Trust Technical Services Units.Guy's and St Thomas' Pharmacy Technical Services encompasses a large number of satellite production and manufacturing units, including Aseptics, Sterile, Non-sterile, Oncology, CIVAS and Radiopharmacy. We have a vacancy for an Environmental Monitoring Technician who will be responsible for assisting the QA Officer for Microbiology in the day-to-day operational management and supervision of environmental monitoring services, including staff, materials and documentation.Candidates will need a good eye for detail, an ability to follow standard operating procedures accurately and be able to plan and prioritise their own workload and the workload of others. An understanding of the critical importance of environmental monitoring and the possible impact on products is also required. The successful candidate will be required to liaise with both the microbiological monitoring team and the wider technical services team.
You will have the satisfaction in being involved in a service that makes a real difference to patient care in a diverse and forward thinking department.
Main duties of the job
To support the pharmaceutical environmental monitoring service in accordance with GMP, recognised standards and current departmental procedures to ensure a safe, efficient and timely service.
About us
Guys and St Thomas' NHS Foundation Trust has a large number of pharmaceutical manufacturing units across the Trust comprising approximately 100 staff. The microbiology team is a small team comprising around 8 staff members.
Job description
Job responsibilities
Environmental monitoring (EM)
- To liaise with the departmental leads and EM assistants and undertake all aspects of EM to ensure the compliant, efficient and timely delivery of EM services.
- To ensure EM documentation is up to date and completed correctly.
- To ensure that all records and logs are correctly filled daily.
- To undertake first line trouble shooting for all elements of the EM service and document resolution. To report unresolved issues the Pharmaceutical Microbiologist.
- To train new staff in all aspects of the service under the direction of the Pharmaceutical Microbiologist.
- To liaise with production units for their requirements for media. To ensure sufficient quantities of media are available to maintain monitoring schedules.
- To monitor usage of EM consumables and report any out of trend usage.
- To oversee the recording of paper and electronic EM data and ensure this is completed in a timely manner in compliance with all departmental procedures. To report any concerns with data integrity to the Pharmaceutical Microbiologist
- To review completed EM worksheets in a timely manner in compliance with all departmental procedures.
- Communicate any Out of Specification results to Production units & provide any relevant information i.e. micro IDs, worksheets, etc.
- Use of QMS & existing databases to raise quality excursions/ obtain relevant data.
- To ensure equipment used for EM is within the calibration date.
- Prepare samples & dispatch documentation for testing with external laboratories.
- Liaise with contract testing labs and other external suppliers as required.
Planning
- To generate the weekly EM plan and prioritise activities and to report any non-compliances with the plan or resource shortages to the Pharmaceutical Microbiologist.
Stock management and dispensing
- Complete catalogue and non-catalogue orders on Oracle.
- Ensure that deliveries are checked and received into the department in a timely manner.
- Manage EM stock, ensuring quarantining of items as required, stock rotation and general stock management including selection/documentation of Growth Promotion Testing.
Supervision and training
- To assist in the supervision and training of EM assistants and ensure that they are aware of what is expected of them in their job roles
- Identify and escalate SOP noncompliance through observation.
General
- To attend courses and undertake training to develop expertise in EM skills and any other skills, where training needs are identified.
- To perform any other duties required in order to maintain the safe, efficient and effective provision of pharmaceutical services at the request of the Trust Chief Pharmacist and Head of Quality.
Job description
Job responsibilities
Environmental monitoring (EM)
- To liaise with the departmental leads and EM assistants and undertake all aspects of EM to ensure the compliant, efficient and timely delivery of EM services.
- To ensure EM documentation is up to date and completed correctly.
- To ensure that all records and logs are correctly filled daily.
- To undertake first line trouble shooting for all elements of the EM service and document resolution. To report unresolved issues the Pharmaceutical Microbiologist.
- To train new staff in all aspects of the service under the direction of the Pharmaceutical Microbiologist.
- To liaise with production units for their requirements for media. To ensure sufficient quantities of media are available to maintain monitoring schedules.
- To monitor usage of EM consumables and report any out of trend usage.
- To oversee the recording of paper and electronic EM data and ensure this is completed in a timely manner in compliance with all departmental procedures. To report any concerns with data integrity to the Pharmaceutical Microbiologist
- To review completed EM worksheets in a timely manner in compliance with all departmental procedures.
- Communicate any Out of Specification results to Production units & provide any relevant information i.e. micro IDs, worksheets, etc.
- Use of QMS & existing databases to raise quality excursions/ obtain relevant data.
- To ensure equipment used for EM is within the calibration date.
- Prepare samples & dispatch documentation for testing with external laboratories.
- Liaise with contract testing labs and other external suppliers as required.
Planning
- To generate the weekly EM plan and prioritise activities and to report any non-compliances with the plan or resource shortages to the Pharmaceutical Microbiologist.
Stock management and dispensing
- Complete catalogue and non-catalogue orders on Oracle.
- Ensure that deliveries are checked and received into the department in a timely manner.
- Manage EM stock, ensuring quarantining of items as required, stock rotation and general stock management including selection/documentation of Growth Promotion Testing.
Supervision and training
- To assist in the supervision and training of EM assistants and ensure that they are aware of what is expected of them in their job roles
- Identify and escalate SOP noncompliance through observation.
General
- To attend courses and undertake training to develop expertise in EM skills and any other skills, where training needs are identified.
- To perform any other duties required in order to maintain the safe, efficient and effective provision of pharmaceutical services at the request of the Trust Chief Pharmacist and Head of Quality.
Person Specification
Skills
Essential
- Demonstrated understanding of the principles of GMP and QA in a manufacturing environment.
- Demonstrated ability to undertake routine physical and environmental monitoring.
- Demonstrated ability to work as part of a team.
- Demonstrated ability to solve routine problems using own initiative.
- Basic IT skills including e-mails, word processing and Excel.
- Demonstrated ability to work under pressure accurately.
Desirable
- Experience of training junior staff in set procedures.
Knowledge/Qualifications
Essential
- Bachelor's degree in Life Sciences or strong professional experience in the industry.
Desirable
- Accredited specialist knowledge for pharmaceutical production to diploma / BTEC level or equivalent gained through experience.
- NVQ 3 in pharmaceutical manufacturing or equivalent experience.
Experience
Essential
- Portfolio demonstrating competence at environmental monitoring in a GMP environment.
Desirable
- Experience of supervising junior staff within a GMP environment.
Person Specification
Skills
Essential
- Demonstrated understanding of the principles of GMP and QA in a manufacturing environment.
- Demonstrated ability to undertake routine physical and environmental monitoring.
- Demonstrated ability to work as part of a team.
- Demonstrated ability to solve routine problems using own initiative.
- Basic IT skills including e-mails, word processing and Excel.
- Demonstrated ability to work under pressure accurately.
Desirable
- Experience of training junior staff in set procedures.
Knowledge/Qualifications
Essential
- Bachelor's degree in Life Sciences or strong professional experience in the industry.
Desirable
- Accredited specialist knowledge for pharmaceutical production to diploma / BTEC level or equivalent gained through experience.
- NVQ 3 in pharmaceutical manufacturing or equivalent experience.
Experience
Essential
- Portfolio demonstrating competence at environmental monitoring in a GMP environment.
Desirable
- Experience of supervising junior staff within a GMP environment.
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
Additional information
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
