Quality , Science, Pharmaceutical & Food

Microbiology Analyst

Posted 1 week ago
Contract
Dublin South
41977856

PE Global are currently recruiting for a Senior QC Microbiologist for a client site in South Dublin.

Senior QC Microbiologist
12 Month Contract
Days position

Overview:
Under minimal supervision, successful candidate would be responsible for one or more of the following activities in QC including microbiological testing, method transfers, sample and data management and equipment maintenance. The Microbiology analyst is for an experienced and technically strong associate who will spend 90% of their work day performing testing. The successful candidate would contribute to team by ensuring the quality of the tasks/services provided by self and contribute to the completion of milestones associated with specific projects or activities within team. The Microbiology analyst will support manufacturing operations, as such some extended hours, shift and weekend work may
be necessary as required.

The position is in the QC Microbiology Lab (Product Team), looking after Endotoxin, sterility, Bioburden, Water utility monitoring and Lab Support duties. It is a Days Role.

Key Responsibilities:

Endotoxin testing of water, in-process and drug product release samples
Bioburden testing of water & in-process drug product samples
Sterility testing & Water sampling
Lab Support duties such as Biological Indicator testing, Growth Promotion, Media Preparation, Identifications and Autoclave.
Writing technical reports
Perform analytical testing as a main priority with efficiency and accuracy
With a high degree of technical flexibility, work across diverse areas within the lab
Plan and perform multiple routine/ non-routine methods and procedures with a large variety of assays.
Report, evaluate, archive, trend and approve analytical data.
Troubleshoot, solve problems and communicate with stakeholders.
Initiate and/or implement changes in controlled documents.
Participate in audits, initiatives, and projects that may be departmental or organizational in scope.
Write protocols and perform assay validation.
Introduce new techniques to the lab, including method transfers, reports, validations and protocols.
Evaluate lab practices for compliance and operational excellence improvement on a continuous basis.
Review and Approve lab results

Qualifications & Experience :

Bachelors degree in a science discipline
Biopharmaceutical QC experience in a microbiology lab
Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products
Experience working in endotoxin, bioburden or sterility testing
Proficient in GMP systems such as LIMS Labware & LMES
Experience in a wide variety of microbiological techniques, including but not limited to Bioburden, Endotoxin, Sterility (in an Isolator), Rapid Micro techniques, Microbial Identification, Media prep, Water Sampling.
Understanding and application of principles, concepts, theories and standards of GMP QC microbiology laboratories. Deepens technical knowledge through exposure and continuous learning
Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery Skills
Strong Technical writing skills for GMP documentation (e.g. investigations, procedures, change controls)
Applies research, information gathering, analytical, and interpretation skills to problems of diverse scope
Ensures compliance within regulatory environment
Develops solutions to technical problems of moderate complexity
Screens, categorizes, evaluates, reconciles, reports, and resolves data integrity issues
Interprets generally defined practices and methods
Technically strong background in microbiology and aseptic manufacturing
Experience in LIMS, Change Control, Trackwise, SAP and CDOCS an advantage