QC Microbiology Senior 29269A
JobTitle: QC Microbiology Senior 29269A
⦁ About Company: Our client based in Dun Laoghaire is seeking a QC Microbiology Senior to join its expanding team.
⦁ Duration of Role: 6 months
⦁ Summary Objective: This role is for an experienced and technically strong associate who will spend 90% of their work day performing testing. This role will support manufacturing operations, as such some extended hours, shift and weekend work may be necessary as required.
⦁ Job Duties:
• Environmental Monitoring of Grade 8/9 Cleanrooms
• Environmental Monitoring of Grade 5/7 Cleanrooms & Isolators
• Reading of Environmental Monitoring Plates
• Bioburden testing of water & disinfectants
• Writing technical reports
• Water sampling
• Testing of In Process samples such as Protein Concentration, Density & pH
• 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, complex routine/ non-routine methods and procedures and a large variety of assays.
• Report, evaluate, back-up/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 and equipment qualification/verification.
• 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.
• Approve lab results
Skills and requirements
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 an aseptic cleanroom performing Environmental Monitoring
• Proficient in the use of LIMS & LMES
• Experience in a wide variety of microbiological techniques, including but not limited to Bioburden, Endotoxin, Sterility (in an Isolator), Environmental Monitoring, 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
o Strong Technical writing skills for GMP documentation (e.g. investigations, procedures, change controls)
• Problem solving skills
o Able to use statistical analysis tools to perform data trending and evaluation
• Project Management and organizational skills, including ability to follow assignments through to completion
• Technically strong background in microbiology and aseptic manufacturing
• Experience in LIMS, Change Control, Trackwise, SAP and CDOCS an advantage
• Flexibility – the EM role often encounters changing priorities on a daily basis (also required to work every 3rd weekend on call)
• Experience with Regulatory inspectors and interacting with inspectors desirable
Benefits of working with Independent Solutions
Benefit from Independent Solutions ethical principles!
We look after our team, we know the business, we have been working in the sector >20 years. We are not a recruitment agency
While placed on client sites you will be an integral part of our team, gaining support and access to the knowledge and experience of our cross functional LifeScience team
We offer attractive rates – competitive margins compared to our competitors.
Payment on time and in full
We continue to partner and grow our client base and thereby ensure that we have continuous supply of High-Value Projects
We work for you !
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Tel: +353 1 5311 280
Fax: +353 1 5311 285