B.S. with minimum 5 years industrial experience in biopharmaceutical industry, such as biology, microbiology, chemistry or related field. Supervisory experience a plus.
• Good analytical and troiuble shooting skills
• Must have excellent technical writing skills and high attention to detail
• Knowledge in cGMP, CFR, USP and other regulations in order to ensure laboratory compliance
• Overcome conflicts with priorities for self and team; consult manager regarding major conflicts
• Have knowledge of environmental monitoring in clean rooms and classified environments
• Strong organizational skills in record keeping, data analysis and strong computer skills
Supervise environmental and clean utility monitoring team, assist manager in planning and prioritizing resource allocation to meet test requirements. Responsible for training staff and overseeing and reviewing documentation.
• Responsible for supervising and training staff
• Scheduling daily work activities and revising as needed
• Reviewing results and writing EM/CU trend reports
• Assist manager and be a back-up when needed
• Assist and Review LIs and Notifications related to EM and CU investigations
• Ensure SOPs are current and compliant with GSK policies
• Ensure adequate inventory of materials at all times
• Ensures L1 Self Inspection procedures for area of responsibility are in place and in use.
• Participate in a sampling of L1 Self Inspections for the area(s) of responsibility.
• Participate on teams involved in EM/CU investigations
• Oversee and/or write Risk Assessments for EM
• Supervise other projects as assigned
You may apply for this position online by selecting the Apply now button.
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