Job Description
Post:
Programme Coordinator (QA & GLP Implementer)
Responsible to:
Helen S Williams (Head of LITE)
Group:
Research Governance and Contracts Office
Summary of role:
The Department of Vector Biology at LSTM is one of the largest of its kind with a broad portfolio of
research and technical assistance activities targeted at improving the control of insect borne
diseases. A dedicated team within the department, the Liverpool Insect Testing Establishment (LITE)
provides a facility for testing lead chemicals for use in the control of public health pests. Our activities
are currently performed according to Good Laboratory Practice and it is our intention to formally
apply for GLP accreditation to MHRA Standards over the next 12 months. This position will
provide compliance support for LITE in readiness of GLP accreditation. The role also involves project
management and training of staff responsibilities and supervision to ensure a smooth transition
to a GLP accredited facility. We are looking for an individual with strong GLP experience with a
Quality Assurance background ideally within an industrial environment. The position is based at
the LSTM.
Main duties:

Define internal audit process within LITE to comply with cGLP, co-ordinate and carry out audits
as defined by this schedule.

Provide review, QA authorisation signature and audit all LITE generated client record sheets
ensuring all documentation meets GLP (Good Laboratory Practice Standards).
1. Set up and maintain a fully validated and compliant system to ensure:
 Document life-cycle management
 Physical and electronic archiving systems
 Planned document review process
 Robust change control system
 A system to support curation of archived documentation
 Testing deviation investigations and resulting CAPAs (Corrective Action,
Preventative Actions) and complaint investigations are backed up by rigorous
process
2. To write and review Standard Operating Procedures (SOPs) using the Document
Management System
3. Provide Quality Assurance and validation advice when setting up specifications/quality
system documents.
Employing risk assessments tools during decision making steps and be able to justify in writing
these decisions.

Implement and operate a programme of supplier audit in liaison with LSTM purchasing team
and approval for raw materials for use in LITE.
Person Specification: Quality Assurance and Compliance Co-ordinator (LITE)
Criteria
Education &
Training
Experience
Competencies

BSc(hons) in science based subject

Relevant experience of working within a research
laboratory in a GLP testing environment

Experience of working to health and safety
regulations and legal requirements , and writing
of relevant risk assessments

Skills, Abilities
and
Knowledge


E
D
E
E

Challenging and investigating nature
E

Excellent verbal & written communication skills,
with the ability to communicate at all levels
E

Numerate, with good working knowledge of
Microsoft Office packages
 EDCL certification

Flexible attitude to work, and excellent time
management skills

An enthusiasm for contributing to a multidisciplinary program and working towards the
goal of improving vector control
Application Form/CV
Application form/CV,
Assessment &
interview
E
Knowledge of health and safety regulations and
legal requirements and ability to carry our risk
assessments
Knowledge and ability to carry out Internal
auditing to aid compliance
Assessment
E


Interests
Documentation controller experience and
experience in quality assurance role in
industrial/compliance based setting.
FDA and MHRA experience
Experience with qualification and validation of
plant equipment and processes.
Essential
Desirable
E
Application form/CV,
& interview
E
E
E
E
E
Application form/CV
& interview