Sign-up for the Sterling-Hoffman Life Sciences Journal to get the latest industry news and job postings.		Job #07276 About our client Our client is engaged in discovering, developing and marketing nuclear medicine imaging agents. Position Location Associate Director, Microbiology MA Salary Highly competitive package, commensurate with experience Responsibilities Partial Job Description 1) Participate as a part of variety of project teams or program initiatives 2) Act as a Technical Resource 3) Communicate information both internally across departments and externally with vendors and business partners, as appropriate 4) Draw expertise and business knowledge to make appropriate decisions that result in high standards of performance 5) Demonstrate the ability to multi-task 6) Allocate time effectively for employee development, coaching, quality achievement, performance, safety standards and etc. 7) Develop and initiate action plans to further enhance technical skills and overall competencies of staff members that contribute to succession plan for quality operations 8) Plan and conduct in-depth trend analysis, department quality and safety audits to ensure adherence to quality standards 9) Monitor key performance metrics and communicate them to management 10) Maintain responsibility for data review, data trending, reporting and analysis 11) Issue trending summary reports, test cycle time and metrics reports as per the site requirements 12) Ensure that all data are timely reviewed and filed appropriately 13) Evaluate and implement improvements where indicated for better efficiency and improved technology 14) Maintain current knowledge of GMP, internal policies, procedures, etc. 15) Ensure staff and department activities along with internal policies 16) Update internal policies and procedures to ensure compliance 17) Ensure maintenance of a safe working environment by increasing staff awareness of safety initiatives 18) Participate in budget process and align operations to meet budget; implement cost savings initiatives 19) Apply necessary oversight for multiple laboratory areas (sterility testing, microbial identification, facility monitoring, etc.) 20) Consult and advise staff as well as third party manufacturers regarding investigations into the causes of quality events 21) Ensure investigations are conducted as per all applicable internal procedures and external regulatory requirements 22) Implement and facilitate corrective measures 23) Ensure all areas of manufacturing and support systems are controlled by microbiological control 24) Serve as an authority for all QC Microbiology functions during audits and inspections Requirements Qualifications / Skills Required 1) BS/BA in Microbiology, Biology or Life Sciences 2) Minimum 7 - 10 years of microbiological laboratory management experience in the pharmaceutical industry or equivalent 3) Experience of working in an environment with exposure to potentially hazardous chemical, radiological and biological materials required 4) Solid managerial skills 5) Skilled at following all safety procedures and ensuring a safe working environment through the use of personal and protective safety equipment 6) Maintain a current knowledge of internal procedures and applicable regulatory requirements 7) Knowledge of manufacturing process preferred 8) Previous experience with budget planning and cost containment preferred 9) Non-routine, overnight travel based on business need may be needed
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