QC Microbiology Technician
Req #: 170008JV_en
Location: Dublin, L IE
Job Category: Quality
Date Posted: 10/10/2017 12:04:58 PM
Job title:QC Microbiology Technician
Location: Baxter Sandyford
Reporting to: Site Microbiologist
The QC Microbiology Technician will support the activities of the QC Microbiology Laboratory and the Quality Department following internal standard operating procedures, and the principles of Good Manufacturing Practice, Good Laboratory Practice and Quality Assurance.
- Performance of specific QC Microbiology Department activities:
Performance of Environmental/Personnel monitoring & non-viable particulate monitoring in Grade C/D cleanrooms
Checking & recording results from Environmental/Personnel monitoring performed within Grade A isolators & Grade C/D cleanrooms
Trending of Environmental/Personnel monitoring & other results
Communicating results to the Quality team & initiating QC Microbiology Investigations for OOS results
Incubation, checking & recording results for Broth media tests
Dispatch of media, broth media tests, microbial isolates & sterility samples for external testing by contract laboratories & assist in the administration of the related documentation
Performance of Micro incubator temperature checks & cleaning
Assist Site Microbiologist & others in completion of NC investigations & other QC Microbiology related tasksAll tasks are to be completed utilising appropriate laboratory and sampling techniques, current procedures & to defined schedules
- Assist in the arrangements for QC Micro equipment calibrations.
- Ensure that working procedures at all times conform with standards of Good Laboratory Practice, The Health and Safety at Work Act, Control of Substances Hazardous to Health Regulations and other relevant legal and professional directives
- Support the management of GMP Documentation within the Quality team under the supervision of the QA Manager.
- Help maintain and update filing and documentation management systems.
- Input data into and generate reports from specific Quality databases.
- Participate in management of critical monitoring systems.
- Support the Quality team with other activities as required within the regulatory and corporate framework.
- Adhere to the local Quality System and Standard Operating Procedures in place for all GxP related activities.
- Support the management of specific Quality Systems activities and any issues arising, such as non-conformances and out-of-specifications to ensure compliance with Baxter GMP and all relevant EU regulatory and legislative requirements.
- In addition candidates should be available to work beyond normal office hours and weekends, as required
Although the above is a description of the requirements of the role, you may be required to carry out other reasonable duties as the Company may require from time to time.
Qualifications & experience:
Third Level qualification (with primary degree or element related to Microbiology/ Biological Science /Sterility Assurance)
The role demands a well-organized approach, underpinned by the ability to communicate effectively with people at all levels, both verbally and in writing. Reliability, IT literacy and the ability to plan and complete projects to set timelines is essential.