James Harrison is a dynamic and focused QA Officer seeking to further develop his skills. He has over 8 years of experience in QA roles, currently serving as QA Officer at BTG Prudhoe where he manages quality systems and processes. His responsibilities include quality management, auditing, process improvement, and ensuring regulatory compliance. He has a Masters in Biomedical Science and is a trained and certified biomedical scientist.

1. James Harrison
27A West Road, Prudhoe, Northumberland. NE42 6HP
James.harrison1988@outlook.com
Mobile: 07540 740 418
Personal Statement
I am a dynamic, focused QA Officer with the drive and determination to make change through quality
process improvements. Decision making and deadline management are the key skills that I utilize to
aid in the achievement of the business key goals and ensuring that all quality objectives are met. I am
looking for a career to further my skills and utilize the skills that I currently have and build towards a
company’s success.
Job Summary
In my current role as QA Officer at BTG Prudhoe, I encompass responsibilities for batch review and
product disposition from site, review all validation activities that occur on site and ensure that these
activities meet regulatory standards including MHRA and FDA.
My main responsibilities are as follows:
 Manage the day to day quality management system (QMS) on site as part of the leadership
team
 Generation of KPI’s for the site and quality metrics and trending
 Writing and updating policies and procedures for the UK based sites
 Managing the training of all staff on site and acting as training coordinator
 Carrying out staff inductions for all new staff ensuring that they are fully integrated into the
team.
 Leading investigations and deviations that arise and ensuring that appropriate CAPAs are
implemented
 Running the onsite quality management review council and feeding these metrics into the
global quality council
 Managing change controls and ensuring that these are agreed with relevant departments and
are pushed through to closure in a timely manner
 Presenter for external audits (MHRA, BSI) customers
 Validation of critical equipment (IQ, OQ, PQ and RQ)
 Implementation of a PPM schedule on site and ensuring that all equipment is maintained
 Generating a site validation master plan for the site and ensuring all validation activities are
carried out in a timely manner
 Ensuring compliance with regulatory bodies on a day to day basis
 Provide feedback to other sites about the status of the site
 Generating a training matrix and determining the level of training required for each member of
the team.
 Ensuring all staff are trained and competency assessed in their roles
 Change management/ planning
 Cost savings through lean process improvements
 Quality improvement planning
 Managing audit responses and generating audit evidence files
Additional Project Management
 Validation of IT software
 Cleaning validation and verification of the site ensuring all previous products are below the
OEL and the site is fit for further use in the BTG production purposes
 Streamlining of global quality procedures to ensure all sites operate to the same policies.

2.  Implementation of the BTG quality system and ensuring that the site transitions from the old
company system into the new BTG way.
 Writing all procedures that are utilized on site and ensuring that training is carried out in these
Technical Skills and expertise
 Risk management and cost benefit analysis
 Leading change management and process improvement
 Excellent communication skills at all levels
 Good computer skills (PowerPoint, word, excel)
 Excellent planner , motivator, organizer and developer
Employment History
October 2014 to Present
BTG Prudhoe
QA Officer
August 2013 to October 2014
Fujifilm Diosynth, Billingham
Principal and EHS Investigator
During this role I was involved in categorising all deviations that occurred during the batch processing
and determining the correct level of investigation required. I was also involved in setting up an internal
audit schedule for the site and determining the frequency of audits and managing all audit responses.
I was also responsible for the EHS budget for the building and ensuring that an effective Kanban
system was set up for all EHS supplies. I carried out all EHS investigations that were reported and
determined the best preventative action to remediate the situations. Lead all deviation review
meetings and ensure that all deviations were tracked and closed in a prompt and effective manner. .
August 2010 to August 2013
Actavis (formerly Eden Biodesign)
QC Microbiologist
Whilst here I was responsible for trending all microbiology excursions that occurred on site and
determining the best way to prevent reoccurrence. I was also responsible for carrying out basic
microbiology test including: plate reading, Gram staining, microbial identification, total viable counts,
endotoxin testing and bioburden testing. I was also responsible for leading all deviations and ensuring
that these were closed out in a timely manner and that preventative actions corrected the problems
and prevented reoccurrence. I was also responsible for reviewing all logbooks that were used on site
and ensuring that these were completed and compliant with GMP.
February 2009 to January 2010
Sheffield Northern General Hospital
Trainee Biomedical Scientist working as a Haematologist
During my time here I was responsible for performing blood counts and diagnosing medical conditions
such as anaemias and leukaemias, Once these were diagnosed we would work closely with the
doctors to determine the best course of treatment for the patients. I was also responsible for carrying
out blood group and typing and ensuring that patients were given the correct blood type to ensure that
there was no adverse reaction when the patients received a blood transfusion.
Education
2006 – 2010 University of Hull
Masters in Biomedical Science specializing in haematology
2004 – 2006 Prior Pursglove College
A levels: Biology, Chemistry, Physics, Law, Classical Civilization

3. 1999 to 2004 Lawrence Jackson School
GSCE A-C in Maths, Science, English, History, Geography, French
Training
2010 Health Profession council registered biomedical scientist
2013 Change management at RSSL
2013 Lean Six Sigma Green belt tools
2014 David Begg Cleaning validation and verification
2015 Steam sterilization and autoclaving principles.
Interests
I enjoy a variety of interests including Rugby, Football and Music – I play a variety of instruments in
my spare time including guitar, piano, violin and double bass reading
References
Available on request