The Microbiology Analyst role is to conduct data review, provide support and guidance in the areas of cGMP, Regulatory, technical investigations, test method validation and environmental control to both laboratory Technicians and various operations work streams. The Microbiology Analyst is responsible for ensuring that all testing is carried out in line with all quality system and regulatory requirements.
This is an initial defined term contract in Galway with excellent possibility for an permanency.
Responsibilities of the Microbiology Analyst:
- Demonstrate a primary commitment to patient safety and product quality.
- Understand and comply with all the regulations governing the quality systems (including ISO 17025 for accrediated laboratory).
- Delivery of key Quality and Performance Objectives.
- Conduct testing according to written procedures - Environmental Control testing (including water/air & surface microbial/air particulate) of controlled areas within the plant, Endotoxin and Bioburden testing (routine/ batch release/ validation) for Microbiology test support; Raw material, in-process and finished product testing for Analytical test support.
- Collect, compile and analyse data and prepare laboratory reports.
- Ensures all notebooks/logbooks/Datasheets are completed and reviewed in a timely manner.
- Records all information and raw data only on designated forms or logbooks and/or via appropriate systems.
- Assist manufacturing/operations/quality in solving quality-related problems.
- Ensures NCE’s, laboratory investigations and out of specification results are documented and reported to Laboratory Management.
- Ensure equipment standards and other materials are approved/released prior to use.
- Performs cleaning, preventative maintenance, verification of instruments and equipment where required.
- Ensure all training is completed as per Laboratory Training Program.
- Communicates any concerns about work process regarding environmental impact, health or safety issues to their Manager.
- Assist in writing and updating Procedures, Work Instruction.
- Ensure training records are current and in compliance with applicable regulations.
- Perform and assist with additional duties as may be directed by the Supervisor.
Requirements of the Microbiology Analyst:
- Minimum of HETAC Level 7 in a Science, Chemistry or related discipline.
- Minimum of 1 - 2 years’ experience in an Analyitcal Laboratory is essential.
- Knowledge & experience of HPLC is essential for this role
Please send an up to date CV and cover note to John Reid at the RFT Group email@example.com/ 01-2302400 / www.rftgroup.ie
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors.