- Reference: GY43631
- Job Type: Permanent
- Location: Limerick
- Category: Science, Pharmaceutical & Food
As QC Microbiology Analyst you will perform a wide variety of microbial testing to support raw material, utilities, in-process and bulk drug substance manufacture in a cGMP regulatory environment.
- Reporting to the QC Laboratory Manager, the person will be responsible for the following;
- Enters a Laboratory Cleanroom to collect and log samples for microbial analysis.
- Performs bioburden and endotoxin sample analysis in accordance with standard operating procedures (SOPs).
- Performs or supports the sample analysis for microbial identification.
- Performs environmental monitoring including surface, settling and viable and non-viable particulate air monitoring of aseptic operations and controlled areas.
- Performs acceptance testing of commercially prepared microbiological culture media.
- Autoclaves microbiological media and laboratory waste as needed.
- Ensures that all work carried out is in compliance with the required regulatory standards, conforms to company policies and standard operating procedures (SOPs).
- Completes own test records on time and peer reviews data from other analysts for accuracy and completeness.
- Assist in the design and set-up of the QC microbiology laboratory and selection/ implementation and calibration of laboratory instruments.
- Participate in microbiological validations as needed for drug substance, in-process controls, buffers and clean utilities qualification program.
- Assist manufacturing personnel in the identification of microbiological root cause analysis and provide technical advice as needed.
- Participates in the transfer of methodology from other test facilities.
- Maintains laboratory reagents, media and supplies.
- Conducts laboratory investigations and generates reports in response to invalid assays, Deviations, OOS/OOT.
- Initiates and completes CAPAs and Change Controls in accordance with site procedures.
- Writes new and updates current SOPs as needed.
- Provides training to other analysts in the QC group.
- Presents analytical data reports clearly and concisely to management.
- Proactively identifies and implements lab process improvements, lean initiatives.
- Performs other duties relevant to the QC laboratory position as required.
Skills, Experience and Qualifications:
- BS/BA in a scientific/technical discipline.
- 1 – 2 years hands-on work experience in a regulated QC Microbiology laboratory within the biopharmaceutical industry.
- Experience with electronic systems such as LIMS, Qumas, eDoc, Trackwise etc., is an advantage.
- Excellent communication skills, both verbal & written.
- Adaptable and flexible, willing to travel when needed.
- Collaboration and team work. Maintains the highest standards of ethical behaviour.
For a confidential discussion and more information on the role/company please email your Cv to Amy: email@example.com