Posted: Tuesday, February 6, 2018 3:36 AM
Valeant Pharmaceuticals International, Inc. is a diverse and decentralized pharmaceutical company that is committed to focusing on our key stakeholders while delivering consistently high performance. Our values provide the overall direction for our company, and provide us with the tools necessary to rise to any challenge by leveraging our collective hard work and effort along with our unwavering competitive spirit. These values help us set goals based on our organizationA cents € (TM) s potential and what we hope it will become. Reporting in to the Senior Laboratory Manager, the Microbiology Manager is responsible for providing strategic and tactical leadership for the Microbiology department. This position supervises three shifts of technicians to provide continuous support to various departments and functions at the Greenville Solutions Facility. The manager provides raw material, in-process, and finished product testing as well as Environmental and Personnel Monitoring to support product release. Informational and data to support to the Global Quality, Research and Development organizations, and other Bausch & Lomb sites is required on an as needed basis. The manager is responsible for establishing strategic goals, budgeting responsibility and providing overall direction and oversight in the attainment, measurement and monitoring of established site level performance metrics. COMPLIANCE: Ensure that the Microbiology laboratory maintains compliance with compendia, cGXP, ISO, governmental regulations, B+L Directives and local procedures, applicable aseptic and other classified environments as well as sterility testing guidanceA cents € (TM) s and regulatory requirements. Create and ensure departmental compliance with safety programs and promote a culture of safety within the microbiology laboratory and the GRN Site. Oversee quality functions including document control, change control, labeling, calibration, standardization, and preparation and storage of standards and reagents. Review, revise and approve test procedures and specifications from corporate R&D, and then communicate and implement them with the microbiology laboratory. Review and release/reject Environmental and Personnel Monitoring, microbial identification testing, sterility testing, particulate matter testing and other diagnostic testing as required. Participate in and/or lead OOS and other quality investigations. Participate and assist in internal and external audits. Investigate and resolve customer complaints as needed. Lead efforts to promote awareness and importance of B+L environmental monitoring directives and microbiological control. MANAGING, PLANNING & DIRECTING: Establish, manage and monitor departmental budget and spending against stated variances. Establish, communicate and execute against strategic quality and site objectives. Provide feedback to product annual reviews (as required), and manage the performance of microbiology laboratory staff. Provide, review and make recommendations for environmental trending and monitoring data for site personnel and management. Promote open communications with the microbiology laboratory and internal customers. Interview, hire and supporting qualified and diverse microbiology laboratory staff. Instituting training programs to develop microbiology laboratory staff. Schedule technicians to meet workload demands of manufacturing and validation. Establish and maintain key operating metrics for Microbiology. Write supporting reports. Perform team meetings to communicate safety, recognition, production, metrics, goals, etc. Provide technical assistance and project support for production, validation and engineering departments. Provide expertise and assistance to troubleshoot and resolve plant / product sterility or aseptic processing issues. Review, write investigation reports. CONTINUOUS IMPROVEMENT: Maintain and continually improve Microbiology processes. Identify, evaluate, select and implement against continuous improvement and compliance initiatives. Evaluating and upgrading microbiology laboratory equipment, instruments and software, capacity and efficiency. Write/review/approve validation and qualification protocols. Write/review/approve SOPs. ENVIRONMENTAL HEALTH & SAFETY: Ensures compliance with OSHA safety guidelines. Ensure adherence with EPA and DHEC waste management guidelines. Must be trained and have a sound knowledge of cGMP, aseptic manufacturing processes, and microbiology laboratory compliance to regulatory guidelines. Should have an expert understanding of Sterility and Aseptic GuidanceA cents € (TM) s, governmental regulations, industry standard in microbiology testing standards and insight into future testing trends (eg rapid micro techniques). Education: BS or MS degree in Microbiology / Biology or related scientific discipline. Experience: 7-10 years of Microbiology work experience of which at least 5 years must be in the supervisory role. Significant experience in environmental monitoring for Pharmaceutical and/or Medical Device aseptic manufacturing facilities is a must.Must have demonstrated expertise and knowledge of sterility testing specialized microbiology laboratory equipment (Vitek, Isolators (VHP Units)) and diagnostic microbiology. Must have demonstrated computer literacy skills (eg Microsoft Office Word and Excel, etc.) Should have demonstrated proficiency in LIMS or other trending database applications.Statistical process control- Six Sigma GB / BB Certification is a plus. Valeant is an EEO/AA employer M/F/D/V. Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms. To learn more please read ValeantA cents € (TM) s Job Offer Fraud Statement.
• Location: Greenville
• Post ID: 27854497 greenville