QC Microbiology Lab Manager

Position Summary: Develop and oversee the Quality Control chemistry program to ensure products are tested in compliance with applicable US Federal and International regulations. Provide support to Production & Registration Departments on international (e.g., Canada, Europe) QC and other related regulatory standards. Assist Management in responding to FDA and other regulatory agencies on technical issues. Ensure that QC personnel interact effectively with the Quality Assurance Unit, Manufacturing personnel, and Engineering personnel. Provide training and development to assure group personnel are adequately skilled to perform assigned functions and that the group operates in an orderly and efficient manner. Essential Duties & Responsibilities Develop, validate and approve methods Plan and direct projects Evaluate and specify instrument purchases Design, implement, approve and assign operational procedures Develop and direct execution of protocols Review and approve data Write and review reports Trainer for advanced techniques, methods and theory Represent QC Microbiology Lab in audits Prepare department forecasts Internal and External customer interface Overall responsibility for the site environmental monitoring and cleaning surveillance programs Present and publish papers Ensure compliance to relevant GMP/GDP And Quality Systems standards Prepare and present reports of departmental measure of appropriate quality to internal management. Establish and maintain documented processes to ensure that product disposition and release of compliant product are performed within agreed lead-times. Education & Special Training B.S./ B.A. in Microbiology or a related technical field is required, an advanced degree is preferred. Experience must include microbiological testing of products in accordance with compendial methods (USP , USP , USP preferred) Experience must include a management position in an FDA GMP (Good Manufacturing Practice) compliant laboratory. Experience with a Laboratory Information Management System (LIMS) is a plus Strong analytical and communication skills are essential with the ability to manage personal and team workloads to ensure high standards are maintained. Awareness/understanding of company products, processes, procedures and personnel. Qualifications & Experience 10+ Years' relevant experience with B.S./B.A. 6+ Years' relevant experience with M.S. 3+ Years' relevant experience with Ph.D. Proven experience in quality management and improvement In depth understanding of quality control procedures and relevant legal standards Excellent math abilities and working knowledge of data analysis/statistical methods Experience with Continuous Improvement tools and applications Excellent organizational and leadership skills Experience in Quality Risk Management 5 to 10 years' business experienceworking with Pharmaceutical Quality Control/Quality Assurance R403255
Salary Range: NA
Minimum Qualification
11 - 15 years

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