Job summary
We have a vacancy for an enthusiastic, self-motivated Quality Manager who can lead and monitor quality aspects within the rapidly expanding Hertfordshire and West Essex (HWE) Blood Sciences service at Health Service Laboratories (HSL). This is an exciting opportunity to join the team during department transformation with 3 different hospital trusts.
The location for the role will begin at Hemel Hempstead Hospital laboratory and transfer to the new HWE Hub in Croxley Park when it opens.
Main duties of the job
The post holder will have post graduate qualifications in Biomedical or Life Sciences and have significant experience of working as a quality lead in a Blood Sciences laboratory with experience of laboratory UKAS accreditation and HTA Inspections. Good organisational and communication skills are essential.
Main duties will include administration, monitoring & implementation of the Quality Management System (QMS) and to oversee quality & compliance activities. Other duties include QMS training across group and to assist in the organisation of and chairing the departmental Quality Management Group meetings.
About us
Training and development opportunities supporting professional development
Annual salary review- No banding restrictions:As we are a private company we are not restricted by salary bandings and so are able to negotiate appropriate salaries based on experience. This also means that annual salary reviews do not hit a band ceiling.
Discounted gym membership we have a corporate gym membership scheme with Better Gyms
Cash healthcare plan cash back on a variety of healthcare costs including dentist and opticians
Sick Pay Entitlement 5 paid days in the first year of employment, 20 days thereafter
Permanent Health Insurance and Death in Service Cover
Life Assurance providing salary continuation for long term illness
Employee Assistance Programme supporting staff wellbeing
Season Ticket Loan Scheme interest free loan for the cost of annual travel ticket
Perkbox Access to additional staff perks and benefits such as high street discounts
Company Pension Scheme company and staff contributions which increase with service
Competitive annual leave allowance28 days
Flexible working hours we support and offer flexibility around shift patterns and working schedule
Job description
Job responsibilities
To administer and monitor the quality management system within the Laboratories.
To oversee local Quality activities in accordance with appropriate accreditation or regulatory bodies e.g.
UKAS, MHRA, GXP etc
Main duties
To include, but not be restricted to, the following duties:
1. To be responsible for retaining, maintaining and continuously improving, the QMS in the
pathology departments.
2. To maintain and implement the Quality Policy for the HSL laboratory as directed.
3. To be responsible for the timely review and application of the Quality processes and
documentation.
4. To organise and contribute to the QMG meetings.
5. To organise and contribute towards the timely and effective running of the Management
Reviews held routinely across the Group.
6. To assist with the identification and establishment of quality objectives and Quality
Indicators, including formulating a plan for achieving these against appropriate and
relevant timescales..
7. To assist in maintaining and further developing systems to facilitate the Continuous
Improvement activities across the HSL Group.
8. To be responsible for the planning, organising and execution of an effective audit
schedule for the department, with support for other Group aligned departments where
necessary. To be responsible for the preparation, administration, dissemination and
routine review of the quality manual.
9. To ensure compliance and maintenance of document control system for the laboratories.
10. To ensure prompt response to enquiries and any follow up, including incidents,
investigations and complaints. To ensure timely preparation of any summary and
investigation reports, in accordance with the requirements of HSL QMG and compliance services.
11. To support and participate in the training of departmental staff in all Quality related
activities.
12. To contribute towards and participate in the ongoing evaluation and improvement
processes for the HSL laboratories.
13. To engage in activities associated with measuring and monitoring performance of the
HSL laboratories.
14. To assist and support the harmonisation of processes and procedures (both quality &
operational) for the department across sites within the HSL laboratories.
15. To ensure all quality related processes are performed in accordance with the relevant
Health and Safety procedures.
16. As required, to provide support to other HSL laboratories
17. To monitor levels of compliance in areas of responsibility in order to identify actual and or
potential risk that may require escalation and take appropriate action.
Job description
Job responsibilities
To administer and monitor the quality management system within the Laboratories.
To oversee local Quality activities in accordance with appropriate accreditation or regulatory bodies e.g.
UKAS, MHRA, GXP etc
Main duties
To include, but not be restricted to, the following duties:
1. To be responsible for retaining, maintaining and continuously improving, the QMS in the
pathology departments.
2. To maintain and implement the Quality Policy for the HSL laboratory as directed.
3. To be responsible for the timely review and application of the Quality processes and
documentation.
4. To organise and contribute to the QMG meetings.
5. To organise and contribute towards the timely and effective running of the Management
Reviews held routinely across the Group.
6. To assist with the identification and establishment of quality objectives and Quality
Indicators, including formulating a plan for achieving these against appropriate and
relevant timescales..
7. To assist in maintaining and further developing systems to facilitate the Continuous
Improvement activities across the HSL Group.
8. To be responsible for the planning, organising and execution of an effective audit
schedule for the department, with support for other Group aligned departments where
necessary. To be responsible for the preparation, administration, dissemination and
routine review of the quality manual.
9. To ensure compliance and maintenance of document control system for the laboratories.
10. To ensure prompt response to enquiries and any follow up, including incidents,
investigations and complaints. To ensure timely preparation of any summary and
investigation reports, in accordance with the requirements of HSL QMG and compliance services.
11. To support and participate in the training of departmental staff in all Quality related
activities.
12. To contribute towards and participate in the ongoing evaluation and improvement
processes for the HSL laboratories.
13. To engage in activities associated with measuring and monitoring performance of the
HSL laboratories.
14. To assist and support the harmonisation of processes and procedures (both quality &
operational) for the department across sites within the HSL laboratories.
15. To ensure all quality related processes are performed in accordance with the relevant
Health and Safety procedures.
16. As required, to provide support to other HSL laboratories
17. To monitor levels of compliance in areas of responsibility in order to identify actual and or
potential risk that may require escalation and take appropriate action.
Person Specification
Qualifications
Essential
- First degree in Biomedical or life sciences.
- Qualification in Quality Management or equivalent experience of working as part of or leading a quality management team.
- Post graduate degree in biomedical sciences.
- Registration with HCPC is not essential but is desirable
Experience
Essential
- Significant experience of working as HCPC registered Biomedical
- Scientist within a Blood Sciences laboratory.
- Previous experience of leading on inspections for laboratory regulatory
- and assessment purposes.
- Significant experience required in Incident identification, investigation,
- root cause analysis and CAPA management.
- Auditing qualification or significant experience.
- Excellent Report writing experience.
Skills and Abilities
Essential
- Excellent written and verbal communication skills.
- Excellent interpersonal skills.
- Ability to work on own initiative and as part of a team.
- Numerate.
- Highly skilled in use of Microsoft Office.
- Able to write reports concisely and precisely.
- Excellent attention to detail skills
Person Specification
Qualifications
Essential
- First degree in Biomedical or life sciences.
- Qualification in Quality Management or equivalent experience of working as part of or leading a quality management team.
- Post graduate degree in biomedical sciences.
- Registration with HCPC is not essential but is desirable
Experience
Essential
- Significant experience of working as HCPC registered Biomedical
- Scientist within a Blood Sciences laboratory.
- Previous experience of leading on inspections for laboratory regulatory
- and assessment purposes.
- Significant experience required in Incident identification, investigation,
- root cause analysis and CAPA management.
- Auditing qualification or significant experience.
- Excellent Report writing experience.
Skills and Abilities
Essential
- Excellent written and verbal communication skills.
- Excellent interpersonal skills.
- Ability to work on own initiative and as part of a team.
- Numerate.
- Highly skilled in use of Microsoft Office.
- Able to write reports concisely and precisely.
- Excellent attention to detail skills
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.