The opportunity
This position is responsible for performing routine and complex microbiological testing on surfaces, air, compressed gases, steam and purified water and is responsible for interpreting and reporting results. This position is also responsible for monitoring and compiling data for quarterly and yearly reports used to track and trend the EM activities, and preparation of media and reagent. This position will serve as the SME for micro and ensure all activities are performed in compliance with regulatory requirements and company policies and procedures.How you’ll spend your day
All areas of responsibility listed below are essential to the satisfactory performance of this position by any incumbents with reasonable accommodation if necessary. Any non-essential functions are assumed to be included in other related duties or assignments.
• Responsible for performing the environmental monitoring of the designated areas and support facilities during and after production.• Responsible for collecting, testing, interpreting and reporting results for water, steam, air and compressed gases for micro testing.• Responsible for performing and qualifying disinfectant studies.• Responsible for validating microbiology test methods.• Responsible for trending and various assessments/reports as required, e.g. quarterly and yearly reports.• Responsible for assuring that required media is available and that the necessary qualifications are met, e.g. growth promotion.• Responsible for conducting microbial identifications, whether by in-house methods or preparing and sending off-site.• Responsible for lab organizational/operational set-up and qualification.• Responsible for supporting validation/qualification activities (process/equipment/facility).• Responsible for developing, transferring and validating microbiology test methods.• Responsible for creating and maintaining a library of microbial organisms.• Responsible for preparing samples for shipment to contract labs as applicable.• Responsible for drafting/amending Standard Operating Procedures (SOP) for the micro lab as needed.• Responsible for preparing written reports of investigations as needed.• Responsible for entering/reviewing data generated by other analyst(s) as needed.• Responsible for supporting production, validation and quality assurance as needed.• Responsible for completing training requirements and maintaining compliance with assignments. • Responsible for maintaining work areas and performing job functions in a safe and efficient manner in accordance with company policies and procedures, Good Manufacturing Practices (cGMP’s), Standard Operating Procedures (SOP’s), Work Instructions (WI) and Batch Record instructions. • Responsible for performing additional related duties as assigned.
Quality
פורסם לפני יותר מחודשיים
פורסמה ברשת
משרות חדשות במערכת שיכולות לעניין אותך

Talent Solution TBO- OS
אזור השרוןאשקלוןהוד השרוןהרצליה / רמת השרוןחדרהחולון / בת יםיבנהלוד / רמלהמודיעיןנתניהפתח תקווהקרית גת / קרית מלאכיראש העיןראשון לציוןרחובות / נס ציונה/ גדרהתל אביב
פורסם לפני יותר מחודשיים
לחברת פארמה בנס ציונה דרוש/ה אנליסט QC ( בקרת איכות) , התפקיד כולל :• ביצוע של בדיקות מבחנים ואנליזות כלי ...












