Research Associate - Quality Specialist
Centre for Cell Manufacturing Ireland (CCMI)
Regenerative Medicine Institute (REMEDI)
National University of Ireland, Galway
Reference number NUIG 107-13
Applications are invited from suitably qualified candidates for the new position of Research Associate – Quality
Specialist at the Centre for Cell Manufacturing Ireland (CCMI) which is based at NUI Galway.
Significant investment has been made at the Centre for Cell Manufacturing, Ireland (CCMI) at NUI Galway. This
investment has seen the development of a 250m 2 facility, housing two independent production suites. CCMI is
seeking to produce medicinal grade human stem cells as Advanced Therapy Medicinal Products (ATMPs) for clinical
trials. The CCMI is managed by the Regenerative Medicine Institute (REMEDI) www.remedi.ie which is a Science
Foundation Ireland-funded biomedical research centre with a primary goal of studying stem cell biology and translating
these findings to new regenerative therapies for human disease. REMEDI is a partnership of scientists, clinicians, and
engineers and it is housed at the National Centre for Biomedical Engineering Science (NCBES) at NUI Galway.
CCMI is currently seeking to recruit a Research Associate - Quality Specialist. The position is fixed term for an initial
period of 12 months.
KEY RESPONSIBILITIES
 Co-ordinate and plan all activities relating to environmental monitoring (viable and non-viable) of classified clean
rooms and to perform the actual monitoring.
 Co-ordinate the incubation of all related monitoring samples.
 Perform enumeration and identification of colonies and record all environmental results.
 Execute analytical procedures for testing of raw materials, intermediate products and final products.
 Receive and inspect/test incoming materials. Assign GRN numbers and record details in Receipt Log.
 Perform Endotoxin testing on finished product and materials.
 Ensure incoming batch materials meet the requirements of the raw material specification and that all associated
documentation is attached and correct. Assign quarantine, rejected and approved labels as appropriate.
 Cleaning and disinfection of Cleanroom areas, when required.
 Co-ordinate and track the generation, revision and approval of controlled documents using Q-Pulse and the MDrive in line with organisation policy and procedures i.e. to operate as Document Control Administrator. Manage
and control the issuance and tracking of controlled records for use in the GMP Facility and GMP Office Area.
 On a monthly basis perform a formal review and update both Inventory and Reference Stock levels. Highlight any
issues with stock levels or expired materials and take appropriate actions such as ordering new material or
obsolete where required. Present review details to management.
REQUIREMENTS

Degree in Microbiology.

2-3 years working in a GMP Manufacturing – QC Environment.

A minimum of 2 years experience in Microbiological sampling/monitoring, testing and identification.

Proven documentation skills in the recording of GMP data and the compilation of Standard Operating
Procedures and Summary Reports.

A minimum of one years experience in the stock control of materials and goods.
Salary: €37,750 per annum
(public sector pay policy rules pertaining to new entrants will apply)
Start date: January 2014
Further information on research and working at NUI Galway is available on Research at NUI Galway
For information on moving to Ireland please see www.euraxess.ie
Further information about REMEDI is available at http://www.remedi.ie; Informal contacts concerning the post may be
made to Andrew Finnerty via e-mail to andrew.finnerty@nuigalway.ie
To apply:
Applications to include a covering letter, CV, and the contact details of three referees should be emailed to
noreen.ryan@nuigalway.ie
Closing date for receipt of applications is 5.00 p.m. on Friday 6th December
Interviews will be held the week of the 16th of December 2013
National University of Ireland, Galway is an equal opportunities employer.