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This role will support manufacturing operations on a 24/7 shift pattern and may include extended hours.
Job Responsibility:
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
Requirements:
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
Nice to have:
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
Experience in LIMS, Change Control, Trackwise, SAP and CDOCS an advantage
Experience with Regulatory inspectors and interacting with inspectors desirable
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