Quality SpecialistQuality ControlNorth Wales, PA, USPay Rate Low: 45.86 | Pay Rate High: 45.86
Added - 23/02/2024
Apply for JobOur client, a global pharmaceutical powerhouse, known for their expertise in developing and manufacturing a wide array of world-class pharmaceutical drugs, life-saving vaccines, and innovative animal-health products, is in search of a Quality Specialist to join their growing team.Type: Contract (6 Months)Duties:
Execute classified facility, utility, and aseptic processing area Environmental Monitoring Program requirements.
Manage change that supports improvement to the Environmental Monitoring program and area sterility assurance.
Support investigation of Environmental Monitoring events.
Trend and evaluate data (e.g. Classified facility Qualification, Requalification, Performance Qualification, Microbial Isolates review, Investigation trending, Process Simulation support, etc.)
Manage/maintain department Environmental Monitoring metrics. Provide detailed analysis of metrics to SLP management for development of action plans.
Use LIMS to plan Environmental Monitoring sampling tasks. Create and/or maintain Environmental Monitoring schedules, sampling locations, and area sampling maps.
Create, update, review, and/or approval Standard Operating Procedures.
Conduct routine Environmental Monitoring tasks, including but not limited to troubleshooting tester questions, making decision on Environmental Monitoring data review, planning facility requalification sampling, and ensuring routine reports are completed on schedule.
Support Utilities Environmental Monitoring requirements, including clean gas and water sampling data trending.
Qualifications:
Bachelor’s degree in Microbiology, Biological Sciences or Chemical Sciences/Engineering with 5+ years of relevant experience, or a Master's degree with 3+ years of relevant experience
Previous experience in an Environmental Monitoring role supporting sterile, biologic, or vaccine operations, and/or process development activities.
Previous experience in aseptic unit operations.
Previous experience in a regulated environment or knowledge of cGMPs.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
