Under minimal supervision, the successful candidate would be responsible for one or more of the following activities in QC including; microbiological testing, method transfers and verification, sample and data management and equipment maintenance.
This role will support manufacturing operations, as such some extended hours, shift and weekend work may be necessary as required.
* 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
* May participate in lab investigations.
* May provide technical guidance.
* May train others.
* May contribute to regulatory filings.
* May represent the department/organization on various teams
* May interact with outside resources
* 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 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)
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
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The Life Science Specialists