Sr Associate QC - Microbiology (24/7 Shift) page is loaded## Sr Associate QC - Microbiology (24/7 Shift)remote type: On Sitelocations: Ireland - Dun Laoghairetime 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* Writing technical reports* Water sampling* Testing of In Process samples such as Density & pH* 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 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**Basic Qualifications*** Bachelor's 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*** Minimum three years' Biopharmaceutical QC experience in a microbiology lab, working as part of an Environmental Monitoring team who directly support manufacturing in a Grade A/B area* 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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