Microbiology Analyst, Cell Therapy
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Microbiology Analyst, Cell TherapyApply Now
The QC Microbiology Analyst is responsible for performing environmental monitoring (EM) and microbiological/analytical test methods on critical utilities, raw materials, in-process intermediates and varying stages of drug products under minimal supervision and within cGMP guidelines, to support manufacturing of Alofisel biologics product at Takeda Ireland Ltd, Grange Castle. The Microbiology laboratory is based in the P3 production building.
- Timely facilitation of incoming sample receipt
- Execute microbiological and/or analytical methods to facilitate in-process testing and final release testing such as Endotoxin, Mycoplasma, and Sterility supporting the release of Alofisel biologics product.
- Execution of method validation/suitability
- Perform environmental monitoring sampling and testing of facilities, equipment, and critical utilities supporting the manufacture of Alofisel biologics product.Evaluate completed assay validity, calculate and summarize results, analyse data per expected or specification ranges.
- Compilation and verification of trend analysis reports.
- Monitoring and control of laboratory supply and critical reagent inventories.
- Perform growth promotion of media and microbial identification testing.
- Exhibit proactive communication upon occurrence of compliance risks and deviations from laboratory procedures; perform initiation of investigation records within required timeframes.
- Provide input support to the progression of test method validation, investigations, technical studies, and method transfer protocols.
- Perform other responsibilities as deemed necessary
- Oversee aseptic practices (gowning, monitoring, cleaning and related training).
- Develop and maintain excellent communication and collaboration between the Microbiology laboratory and operations.
- Training of other microbiology analysts where necessary
- Ensure that testing schedules are achieved and manage laboratory resources (instruments and personnel) to provide a comprehensive analytical service for testing of all samples.
- Participate in the technical transfer / validation of microbiological testing procedures including Mycoplasma, Sterility testing and Endotoxin testing
- Participate in root cause analyses (RCA) as part of investigations into any non-conformance, instrument malfunction, accident or other abnormal occurrence.
- Ensure that any Out of Specification (OOS) or Out of Trend (OOT) analytical results are managed as per SOP.
- Prepare and review documents as required.
- Prepare for, and support, internal and external audits (e.g. HPRA, FDA, corporate).
- Actively support projects, quality initiatives and continuous improvement programmes within the Quality department and in other functional areas.
- Implement and maintain standards of safety to ensure a safe working laboratory. Ensure that the laboratory is kept clean, tidy and safe at all times.
EDUCATIONAL REQUIREMENTS/REQUIRED SKILLS
- Degree in Microbiology or other relevant field.
- At least 1 - 2 years’ experience working in Microbiology in the pharmaceutical industry, preferably in a Biologics company Strong knowledge and practical experience in aseptic techniques and working in Grade A/B facility.
- Experience of microbiology testing including Sterility, endotoxin, mycoplasma and Environmental Monitoring
- Knowledge of GMP and current FDA & EMEA regulations
- Knowledge and experience of Lean Laboratories is preferable
- Excellent organizational, communication, interpersonal and report writing skills
- Good Microbiology knowledge
- Ability to adapt to changing priorities
- Ability to work independently and meeting established timelines.
- Knowledge of cGMPs.
- Successful track record in achieving goals as part of a team within a growing, dynamic environment
- Demonstrated adaptability and flexibility to support a growing organisation.
- Self-motivated and ability to work under pressure
LocationsGrange Castle, Ireland
Time TypeFull time
Job ID R0036034