QC Microbiology Analyst

CPL

Limerick

QC Microbiology Analyst Location: Limerick. Job Summary and Essential Functions: Summary: Perform a wide variety of microbial testing to support raw material, utilities, in-process and bulk drug substance manufacture in a cGMP regulatory environment. Responsibilities. 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. Experience and Required Skills: Requirements. • 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. • Results and performance driven. • Strong analytical ability and associated problem solving. • Good time management and attention to detail. • Knowledge and proficient in the use of Microsoft products including, Excel, Word and Powerpoint. Preferred Laboratory Experience. • Microbiology. o Bioburden. o Microbial Identification. o Water Testing – Endotoxin. o Environmental monitoring. o Cleaning and validation studies. o Familiar with USP, JP and EP methodology. This job originally appeared on RecruitIreland.com.

2801 days ago