Associate QC Micro (24/7) page is loaded## Associate QC Micro (24/7)remote type: On Sitelocations: Ireland - Dublintime type: Full timeposted on: Posted Todayjob requisition id: R-******## **Career Category**Quality## ## **Job Description**This role will support manufacturing operations on a 24/7 shift pattern and may include extended hours.
**Specific 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* Water sampling* Testing of In Process samples such as pH* Initiate and/or implement changes in controlled documents.
* Participate in audits, initiatives, and projects that may be departmental or organizational in scope.
**Basic Qualifications*** 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.
**Preferred Qualifications*** Experience working in an aseptic cleanroom performing Environmental Monitoring* Proficient in the use of LIMS & LMES* Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery* Biopharmaceutical QC experience in a microbiology lab* Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products**Competencies*** 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* Problem solving skills* Experience with Regulatory inspectors and interacting with inspectors desirable* Demonstrated ability to work independently and deliver right first time results* Works under minimal direction* Work is guided by objectives of the department or assignment* Follows procedures* Refers to technical standards, principles, theories and precedents as needed* May set project timeframes and priorities based on project objectives and ongoing assignments.
* Recognizes and escalates problems* Auditing documentation and operation process* Demonstrated ability to interact with regulatory agencies.
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