[{"country_short": "USA", "city": "Rochester Global Eye Health Center Site", "description": "Title: Lab Technician IV, Microbiology\nLocation: United States-New York-Rochester Global Eye Health Center Site\nJob Description: \nThis position would be in support of the Rochester Plant Environmental Monitoring and Technical Services Group. Knowledge of defined areas within the primary function. Performs analysis and provides recommendations within established guidelines. Performs specifically defined work/projects. Contributes as a team member. May participate in quality projects or teams. Typically an individual contributor with assigned specific work/tasks.\n\n\u2022 Support of environmental/water monitoring for the Rochester Optics Center.Specific responsibilities include scheduling, sampling, testing and maintenance of supplies.\n\u2022 Perform microbiological testing as part of the core competency function. Includes routine testing and validation support to the Rochester Plant and D & R.\n\u2022 Familiar with the layout of the plant, where sample locations are, etc\n\u2022 Provide support for Plant Sterilization Requalification program e.g., data review\n\u2022 Involvement with root cause investigation related to environmental monitoring level excursions\n\u2022 Preparation/revision of memos, reports, SOPs and protocols.\n\u2022 Perform data study review for peers.\nWill be expected to cross-train and help in other areas over time\nRepresent group at Microbiology Summit\n\nBausch  Lomb is one of the best-known and most respected healthcare brands in the world, offering the widest and finest range of eye health products including contact lenses and lens care products, pharmaceuticals, intraocular lenses and other eye surgery products. The company is solely dedicated to protecting and enhancing the gift of sight for millions of people around the world \u2013 from the moment of birth through every phase of life. Our mission is simple yet powerful: Helping you see better to live better.\n\nBausch  Lomb is an equal opportunity employer.\nAssociate degree or equivalent through specialized training required (Bachelor level degree a plus) in Life Sciences (Biology / Microbiology / Biotechnology) preferred.\nA minimum of 4-6 years work experience in a related field is required.\nComputer skills \u2013 Microsoft Office Suite.\n\nJob: Quality", "date_new": "2012-05-16 18:25:51", "url": "http://bausch.jobs/xml/28734503/job", "country": "United States", "company": "Bausch + Lomb", "title": "Lab Technician IV, Microbiology", "reqid": "00007708", "state": "New York", "state_short": "NY", "location": "Rochester Global Eye Health Center Site, NY", "uid": 28734503}, {"country_short": "USA", "city": "Aliso Viejo Site", "description": "Title: Sr. Product Surveillance Specialist\nLocation: United States-California-Aliso Viejo Site\n\nReceiving, evaluating, and documenting information on all domestic and international complaint files\nMust be able to make adverse event reporting determinations to meet FDA, ISO and international regulatory requirements\nMust be able to file regulatory reports to appropriate regulatory agencies\nAbility to interact with Quality Assurance, Engineering, and others as required to address DHR review, root cause analysis and process review to prevent recurrence\nDuties include ability to perform data entry, create file folders, labels, letters, filing, fax, scan, and associated duties as required\nContacting complainant via phone or letter to clarify or obtain additional technical information to resolve complaint\nAbility to interpret, follow and make required revisions to standard operation procedures required\nCompile, review and close complaint files\nAssist with projects as required\n\n\nBausch  Lomb is one of the best-known and most respected healthcare brands in the world, offering the widest and finest range of eye health products including contact lenses and lens care products, pharmaceuticals, intraocular lenses and other eye surgery products. The company is solely dedicated to protecting and enhancing the gift of sight for millions of people around the world \u2013 from the moment of birth through every phase of life. Our mission is simple yet powerful: Helping you see better to live better.\n\nBausch  Lomb is an equal opportunity employer.\nPosition requires 5-8 years of related work experience.\n\nBachelor's degree is required (preferably in a health related field).\n\nKnowledge of ophthalmic medical terms, Medical Device Reporting\nregulations, Vigilance reporting regulations, and GMPs for medical devices\npreferred.\n\nPosition requires strong written, verbal and listening communication skills\nin order to interact with customers and other professionals. Candidate must be\nable to generate and organize clear, concise responses at different levels of\nmanagement is required.\n\nCandidate must be proficient in the use of personal computer, including\ndatabase management, trending and word processing.\n\n\nJob: Quality", "date_new": "2012-05-15 19:56:44", "url": "http://bausch.jobs/xml/28707347/job", "country": "United States", "company": "Bausch + Lomb", "title": "Sr. Product Surveillance Specialist", "reqid": "00007711", "state": "California", "state_short": "CA", "location": "Aliso Viejo Site, CA", "uid": 28707347}, {"country_short": "USA", "city": "Rancho Cucamunga Site", "description": "Title: Quality Analyst\nLocation: United States-California-Rancho Cucamunga Site\n\nThis is a key position with complete responsibility in the Quality Assurance Department in a manufacturing/engineering environment. The QA Analyst will utilize analytical tools and techniques in order to evaluate returned product for complaints. \n\nSpecific Job Duties:\nThe responsibilities of a QA Analyst include:\n* Receiving, documenting, and logging product complaints into the complaint system;\n* Decontaminating and evaluating product returned from the field for complaint investigations;\n* Conducting DHR reviews;\n* Generating evaluation reports; and\n* Closely working with Global Product Safety and Surveillance on complaints and other special projects.\n\nAs an integral part of the team, the ideal candidate must be able to:\n* Work with miniscule product delicately;\n* Work as part of a team and with minimal supervision;\n* Effectively communicate orally as well as through written communication;\n* Be organized and detail oriented;\n* Navigate and operate MS Word and Excel;Understand ISO and Quality System Regulations.\n\n\n\n\nBausch  Lomb is one of the best-known and most respected healthcare brands in the world, offering the widest and finest range of eye health products including contact lenses and lens care products, pharmaceuticals, intraocular lenses and other eye surgery products. The company is solely dedicated to protecting and enhancing the gift of sight for millions of people around the world \u2013 from the moment of birth through every phase of life. Our mission is simple yet powerful: Helping you see better to live better.\n\nBausch  Lomb is an equal opportunity employer.\nHigh school diploma or equivalent is required with a minimum of 2 years experience working in a regulated medical device environment, preferably in the IOL industry.\n\n\nJob: Quality", "date_new": "2012-05-11 20:16:13", "url": "http://bausch.jobs/xml/28640262/job", "country": "United States", "company": "Bausch + Lomb", "title": "Quality Analyst", "reqid": "00007707", "state": "California", "state_short": "CA", "location": "Rancho Cucamunga Site, CA", "uid": 28640262}, {"country_short": "USA", "city": "Rochester Global Eye Health Center Site", "description": "Title: Stability Statistician\nLocation: United States-New York-Rochester Global Eye Health Center Site\nThis Senior Scientist position is responsible for developing global stability analysis strategies for regulatory submissions of newly developed products and product line extensions for existing products.  Working in conjunction with stability operations leads at the company\u2019s manufacturing sites this role will establish requirements for trend analysis, shelf-life establishment, and out-of-specification risk assessments for marketed products. This position will also be responsible for the statistical evaluation of chemical and microbiological data generated by the company\u2019s laboratory operations. \n\nSpecific Job Duties:\n\u2022 Review of analytical and microbiological data to determine trends: determination of emerging data trends, leveraging stability data to predict shelf-life of new development products or products undergoing design changes, and assisting in setting appropriate specifications around the performance of analytical methods.\n\u2022 Participate in the Global Specification setting process\n\u2022 Prepare the stability submission reports for development products for IND, NDA, or other submissions\n\u2022 Determine risk of OOS during specification change process\n\u2022 Participate in the writing of annual reports for ongoing annual commitment stability program\n\u2022 Serve as technical resource for critical investigations, determining risk of OOS, evaluating process interactions, or other statistical evaluations of available data\n\u2022 Propose global process improvements and in building efficiencies across studies/sites.\n\u2022 Assist in defending strategy and findings to FDA.\n\n\nBausch  Lomb is one of the best-known and most respected healthcare brands in the world, offering the widest and finest range of eye health products including contact lenses and lens care products, pharmaceuticals, intraocular lenses and other eye surgery products. The company is solely dedicated to protecting and enhancing the gift of sight for millions of people around the world \u2013 from the moment of birth through every phase of life. Our mission is simple yet powerful: Helping you see better to live better.\n\nBausch  Lomb is an equal opportunity employer.\nQualifications:\nAn MS degree in math/statistical analysis with 3 years experience or a BA/BS degree with a minimum of 5 years experience. Knowledge of FDA/ICH guidances on interpretation of stability data a must. Previous experience with analytical and microbiological data a plus.  Knowledge of linear regression and non-linear analysis tools is a must. Knowledge and experience in LIMS systems would be very beneficial.  Must have sound working knowledge of statistical theory and application including experimental design, linear models, ANOVA, etc. \n\n\nJob: Quality", "date_new": "2012-05-01 19:32:40", "url": "http://bausch.jobs/xml/28306112/job", "country": "United States", "company": "Bausch + Lomb", "title": "Stability Statistician", "reqid": "00007676", "state": "New York", "state_short": "NY", "location": "Rochester Global Eye Health Center Site, NY", "uid": 28306112}, {"country_short": "USA", "city": "Greenville Site", "description": "Title: Sr. Validation Engineer - Process Validation\nLocation: United States-South Carolina-Greenville Site\nPosition Summary\n\nBausch Lomb is seeking a talented Sr. Validation Engineer for our Greenville, SC aseptic fill/finish manufacturing facility. Will provide leadership as the Process Validation subject matter expert, support new product transfers, modifications for existing products and components while adhering to the new FDA pharma process validation guidelines (CGMP). This position will offer the opportunity to influence and negotiate through cross functional interface (R & D, Operations, Quality, Statisticians, Scientists) as required. Solid experience using statistical methods and prior leadership experience desired.\n\nSpecific Job Duties\n* Remain current on cGMP practices for Process Validation and ensure local Process Validation SOPs and validation documents reflect current industry practices.\n* Provide validation requirements, strategy, protocols, execution and final reports for changes impacting validated products and critical process parameters.\n* Oversight of validation activities for R & D trials and new products. \n* Support engineering testing/trials and requirements for final product changes.\n* Creation, review and update of risk analysis for changes and new processes that impact products. \n* Conduct periodic review of validated processes.\n* Peer review validation studies executed by other validation team members\nBausch  Lomb is one of the best-known and most respected healthcare brands in the world, offering the widest and finest range of eye health products including contact lenses and lens care products, pharmaceuticals, intraocular lenses and other eye surgery products. The company is solely dedicated to protecting and enhancing the gift of sight for millions of people around the world \u2013 from the moment of birth through every phase of life. Our mission is simple yet powerful: Helping you see better to live better.\n\nBausch  Lomb is an equal opportunity employer.\nEducation: \nBS Engineering or Science\n\nExperience:\n\nRequired:  5 years Process Validation experience in Pharmaceutical, Medical Device or Parenterals. Must have experience in either an FDA or ISO Regulated Industry\nDesired:  Demonstrated experience and proficiency with cGXP, ICH and PIC/S. Experience with regulatory and/or third party audits\n\nSpecial Skills:\nStrong Verbal and Written Communication; Self Driven, Result Oriented, Strong knowledge of Process Validation, Project Management, Intermediate Statistics Knowledge (sampling plans, hypothesis testing, etc), use of pfmea risk assessment or similar\n\nSpecialized Training:\nRequired:  FDA Process Validation Guidance, Statistical Sampling, Technical Writing, Use of MiniTab.\n\nDesired:  Conducting and leading investigation, project management, Design of Experiments\n\nJob: Quality", "date_new": "2012-04-04 18:45:01", "url": "http://bausch.jobs/xml/27641251/job", "country": "United States", "company": "Bausch + Lomb", "title": "Sr. Validation Engineer - Process Validation", "reqid": "00007633", "state": "South Carolina", "state_short": "SC", "location": "Greenville Site, SC", "uid": 27641251}, {"country_short": "USA", "city": "Rochester Global Eye Health Center Site", "description": "Title: Quality Fellow: Microbiology & Aseptic Manufacturing Center of Excellence\nLocation: United States-New York-Rochester Global Eye Health Center Site\nPosition Summary \n\nThis Executive level, high impact position within the Quality organization will continue building a world class sterility assurance platform and program supporting Bausch  Lomb\u2019s manufacturing and distribution locations.  The person in this position will also provide expertise in Microbiology, Aseptic Manufacturing and Sterilization solving complex problems and influencing significant decisions impacting the company\u2019s manufacturing operations. The role reports to the Vice President, Global Quality and will frequently interact with and make recommendations to senior leaders of the company.\n\nSpecific Job Duties\n* Establish aseptic manufacturing, environmental manufacturing and facility/utility standards for B L and Contract Manufacturing sites in partnership with the site quality functions.\n* Direct microbiology, aseptic manufacturing and sterilization core competencies supporting vision care, surgical and pharmaceutical product and process management programs.\n* Establish a training program for manufacturing and laboratory personnel and international affiliates.\n* Consult with all global functions (R & D, manufacturing, quality, regulatory, marketing, and legal) to solve microbiological, contamination control and product-related issues.\n* Lead and participate on project teams that improve performance in the area of aseptic manufacturing excellence.\n* Develop goals, objectives and plans for manufacturing operations staff involved in aseptic manufacturing and microbiology.\n* Establish / monitor environmental monitoring programs for all lens manufacturing areas.\n* Assist with corporate audits of manufacturing facilities and contract vendors.\nBausch  Lomb is one of the best-known and most respected healthcare brands in the world, offering the widest and finest range of eye health products including contact lenses and lens care products, pharmaceuticals, intraocular lenses and other eye surgery products. The company is solely dedicated to protecting and enhancing the gift of sight for millions of people around the world \u2013 from the moment of birth through every phase of life. Our mission is simple yet powerful: Helping you see better to live better.\n\n* BS degree in microbiology or related discipline; MS or PhD. degree preferred.\n* Minimum of 10 years experience in an aseptic manufacturing environment in an influential senior leadership role within a Quality organization (e.g. Quality Manager, Director or Senior Technical Consultant).\n* Must have demonstrated experience establishing aseptic manufacturing, environmental manufacturing and facility/utility standards for a world class organization.\n* \nSignificant knowledge and experience in microbiology, sterilization and validation.\n* Demonstrated track record of developing Quality systems, processes and programs across global regions.\n* Excellent consultative approach and expert trouble shooting and problem solving capabilities.\n* Must be available to potentially travel 25-35% of time (domestic and global). \nManagerial Responsibility\n* No direct reports, but may manage project related activities.\n\n\nJob: Quality", "date_new": "2012-03-09 22:51:32", "url": "http://bausch.jobs/xml/27051260/job", "country": "United States", "company": "Bausch + Lomb", "title": "Quality Fellow: Microbiology & Aseptic Manufacturing Center of Excellence", "reqid": "00007592", "state": "New York", "state_short": "NY", "location": "Rochester Global Eye Health Center Site, NY", "uid": 27051260}, {"country_short": "USA", "city": "Clearwater Site", "description": "Title: Quality Engineer\nLocation: United States-Florida-Clearwater Site\n\nSummary:\nThe role of Quality Engineer Insertion Devices is integral to the on-going compliance of the inserter manufacturing processes. The Quality Engineer is involved in all stages of the product life cycle including:\n\n\u00b7 New Product Support:Works with project teams to ensure the product is transferred into manufacturing right the first time and validations are conducted in accordance with requirements.\n\u00b7 Manufacturing support: Leads efforts in conjunction with manufacturing and engineering to develop plans for continual improvement of product and process quality. Ensures that decisions are made based on sound Quality principles and regulatory guidelines. Supports/leads investigations and corrective action efforts. Promotes use of statistical analysis for determination of improvements, and provides analyses to support risk mitigation.\n\u00b7 Post-launch maintenance: Evaluates complaint trends and drives improvements. Investigates individual complaints as needed.\n\nManufacturing Support\n\u00b7 Supports manufacturing in improvement of processes, resolution of issues, maintenance/ improvement of quality system.\n\u00b7 Uses Lean/six sigma tools to identify areas of improvement, specifically related to process controls.\n\u00b7 Guides engineering/manufacturing personnel in establishment of appropriate qualification, validation criteria. \n\u00b7 Evaluate proposed changes for design control requirements.\n\u00b7 Independently leads failure investigations, using root cause analysis tools, and proposing/implementing systemic corrective actions. Identifies areas of systemic weakness, and leads initiatives to implement corrective action.\n\nAnalyzes data\n\u00b7 Uses relevant statistical tools to analyze data for proactive improvements.\n\u00b7 Uses relevant statistical tools for leading problem solving activities.\n\u00b7 Provides routine analysis of performance indicators. Presents this information to management, supervisors, and manufacturing operators. Leads initiatives to improve performance.\n\nCore team member for new product development\n\u00b7 Key participant in the design transfer process. Guides project team in development of validations of the manufacturing process and quality plans for the integration into manufacturing. \n\u00b7 Evaluates current Quality System, and determines how new products will fit within system. Determines if any changes are required.\n\u00b7 Leads teams to develop PFMEA for new processes and process changes. Focus team on implementing capable processes, process controls, and error-proofing measures.\n\u00b7 Develops/updates Risk Management files.\n\u00b7 Support development of verification and validation strategies. Guides team on proper components of IQ/OQ/PQ/PV activities.\n\nBausch  Lomb is one of the best-known and most respected healthcare brands in the world, offering the widest and finest range of eye health products including contact lenses and lens care products, pharmaceuticals, intraocular lenses and other eye surgery products. The company is solely dedicated to protecting and enhancing the gift of sight for millions of people around the world \u2013 from the moment of birth through every phase of life. Our mission is simple yet powerful: Helping you see better to live better.\n\nEducation:  \nFour-year college degree (BA/BS) in fields such as life or physical sciences, or engineering. \n\nExperience:\n2-4 years Quality experience. Experience with medical devices preferred. Strong verbal and written communication skills, ability to manage multiple priorities. Working knowledge of 21 CFR 820, ISO 13485, ISO 9001, Quality tools, and problem solving tools, statistical analysis. \n\nSpecial Skills:\nQuality Tools - Quality Planning, Costs, Assessment, Basic /or Advance Statistical Techniques, Tech Writing, Metrology & Calibration, Inspection & Testing, Sampling Principles & AQL, TQM, Six Sigma\n\nProblem Solving Tools - Process Mapping, Histograms, FMEA, Risk Assessment, Cause & Effect Diagrams, PCDA, Pareto Analysis\n\nComputer & Information Technology Skills \u2013 Windows, Word, Excel, Power Point, Project, Visio, statistical software (i.e. Minitab).\n\nSpecialized Training:ASQ Certified Quality Engineer or equivalent preferred.\n\nJob: Quality", "date_new": "2012-02-11 00:17:02", "url": "http://bausch.jobs/xml/26469742/job", "country": "United States", "company": "Bausch + Lomb", "title": "Quality Engineer", "reqid": "00007503", "state": "Florida", "state_short": "FL", "location": "Clearwater Site, FL", "uid": 26469742}]