Coordinate the activities and programs for Biological Quality Assurance (BQA) Environmental Monitoring group.
Coordinate the activities and programs for Biological Quality Assurance (BQA) Environmental Monitoring group. Manage, train, and develop a staff of technical support personnel that conduct quality functions mandated by regulatory agencies, such as sampling, testing, validation, generation of critical production and quality documentation, investigation of non-conformance and auditing, and/or performance of other related cGMP functions. Determine suitability of the environment and disposition of batches based on laboratory results and/or review of primary cGMP documents. Develop/implement criteria and systems to assure quality of the aseptic environment, documents, test results, and products. Review departures from procedures and recommend actions. Approve GMP records. Meet throughput goals for batch disposition, assessment, investigations, and validation projects. Implement approved changes in collaboration with BQA, production, regulatory, and client. Identify issues requiring review by management. Work collaboratively with clients, labs, production and other departments as needed to meet customer requirements. Establish actions and implement systems to achieve process improvements and efficiencies to address shortcomings in processes and systems. Serve as principle in problem solving, failure analysis, and quality or process system design activities related to product quality. Evaluate protocols, procedures, documents and results for scientific and/or business merit. Write appropriate reports and correspondence. Participate in customer and regulatory audits, providing information about the environmental monitoring program in response to audit questions. Work in a safe and responsible manner in order to create an injury-free and incident-free workplace. Comply with all job-related safety and other training requirements.
BS in biological science or related discipline plus four years of relevant experience including 2 years leadership experience. Or AA/AS degree in biological science or related discipline plus 5 years of relevant experience including 2 years leadership experience. Or 6 years laboratory experience including two years leadership experience. Prior experience leading the evaluation and resolution of complex technical problems and multi-party negotiations to obtain results. Intense, sustained intellectual effort using innovative thinking to achieve results. Broad knowledge and experience in microbiology, environmental monitoring, utilities, clean room/facility build, start-up and approval, production and aseptic processes/techniques, aseptic gowning procedures, validation, sterilization, risk management (failure mode analysis (FMEA), and problem-solving/troubleshooting techniques. Strong decision-making skills, Knowledge of environmental monitoring method development approaches, validation, environmental monitoring statistics (tracking/trending), documentation, and adherence to SOP’s. Broad knowledge of cGMPs, guidance documents, global regulatory requirements, and other applicable standards (WHO, ISO, ICH, IEST, PDA, AAMI). Demonstrated ability to perform investigations of complex issues including nonconformance deviations, excursion investigations, and media fill investigations.
The Procedure and Contact
DSM's wide diversity of disciplines makes it possible to offer employees a great variety of roles throughout their career. For instance, you may start your career in an area related to your education/qualifications, but your future is what you make of it.
At DSM we stimulate people to determine their own career path and we encourage international careers. We strive to be an Employer of Choice and ensure that our employees are nurtured and given the opportunity to develop their talents.
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We offer a challenging and rewarding job in an innovative multinational company with several opportunities for personal input and development; an open and dynamic atmosphere; a 'never-stop-learning' attitude. Terms and conditions of employment as well as fringe benefits are market competitive.
Please apply online at www.dsm.com/vacancies . The procedure is in line with what you can expect from an Equal Opportunity Employer.
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