VS. Research, Audiology, Microsoft Excel, Microsoft Word, Publications, Ideal Companies: Tribhuvan University, Tribhuvan University, Tribhuvan University, Tags for this Online Resume: If you cannot complete the Application Package online, you may fax all of your materials. Master's preferred, Must have achieved Micro I status for 3 years - internal candidates, Prior use of ELISA and PCR detection techniques, Knowledge of USDA, FDA, AOAC, ISO and IDF methodologies, Experience testing multiple food matrices (dairy products, raw and ready to eat meat products, produce, etc. Basic computer skills are necessary, Ability to communicate clearly, interact effectively, and work well within a team-oriented operation, Effective written and verbal communication skills, including teamwork and customer service skills, Must be highly motivated, careful and willing to adapt to new procedures, Ability to operate or learn to operate the alkaline hydrolysis tissue digester and overhead hoist system is, Knowledge of biological safety handling procedures and appropriate disposal of biological hazards, Knowledge of Quality Assurance and Standard Operating Procedures, Knowledge of laboratory procedures, lab equipment operations and equipment maintenance techniques, Ability to maintain confidentiality of test results, Passive/Active Air Sampling (ability to routinely lift 20-30 pound air sampler), Perform utility sampling – steam, gas, water – and deliver to lab for analysis, Ensure all work is performed/documented in a GMP compliant manner and per applicable regulatory and client requirements, Participate in lean lab operation, 6S laboratory layout, preventive action, and continuous improvement programs to reduce operating costs, Conduct and document investigations as needed, Perform other housekeeping tasks as needed to maintain area (glassware washing, inventory/restocking of supplies, etc), Participate in cross-training functions as needed to support QC area, Prior experience in a Quality Control environment, Knowledge of GMPs, safety regulations, and data integrity, Understanding and application of cGMPs in a production environment, Familiarity with USP1116, ISO14464, and Annex 1, Bachelor's degree in scientific discipline, Perform weekend-work on rotational basis to support manufacturing operations, Perform weekly, monthly and quarterly environmental monitoring tests, Track, perform and report FMA test requirements, Track and acquire product bioburden samples for quarterly tests, Prepare samples and test request forms for external contract tests, Coordinate and execute CEA recertification efforts, Perform and write reports for quarterly dose audits radiation product families, Perform annual EO sterilization cycle revalidations, Serve as microbiology and sterilization member on product development teams, Evaluate data to support sterilization validation runs, Understands EO residual and tolerable contact limit applications, Develop and implement test methods to support environmental or product testing, Completes annual continues improvement project, Determine impact of Gap analysis of standards, Serve as a SME in at least one departmental area, Two years of relevant experience required, Excellent organizational skills (schedules, prioritization, traceability) required. HPRA, FDA) desirable, Masters of Science (M Sc) in Microbiology, IT skills (Microsoft words, Excel and Power point), Providing analytical support to MLT Section, Performing and manage assigned laboratory duties, Perform MLT of raw materials, non-sterile bulk and finished products , bulk for filtration of sterile products, Perform BET of products ,raw materials, WFI and Steam condensate, Checking of Graph recorders of Sterilizers of Production and Micro Lab, Ensure to perform tests according to GSK specification to meet the schedule, Perform ATM validations for MLT of Products and prepare review reports, Assists in Compliance of Level I ,Level II and Level III Audits, Performing tests and Documenting results GSK Standards. degree in Biological Sciences, preferably Microbiology, with minimum of 5 years of Pharmaceutical Microbiology Laboratory work experience with background in test method development and method validation/re-validation, aseptic processing and sterility assurance, The incumbent must have strong interpersonal, written, and verbal skills. Previous experience with Laboratory Information Management System (LIMS) is preferred, Microbiological testing lab experience in the pharmaceutical industry. Microbiological qualification involving sterilization processes, and environmental controls and microbiology laboratory testing, Moderate knowledge of laboratory test method validation, Knowledge of Good Manufacturing and Good Documentation practices supporting medical device manufacturing, Ability to interact at the highest professional manner with all organizational levels, Excellent communication skills, both verbal and written, and interpersonal skills to effectively interact with and contribute constructively to team environment / outside departments and externally, Proven experience working with and understanding requirements for sterilization with knowledge of relevant ISO standards is strongly preferred and experience with regulatory compliance, Must have aseptic techniques for bioburden and sterility tests, microbiological inoculums, assays, pipettes. third party laboratories), Good knowledge of Regulatory, GMP’s and ISO Quality management system standards, Define the strategy for preservation of the products developed by the Consumer Health organization. Federal law requires DHS to use the E-Verify System to verify employment eligibility of all new hires, and as a condition of continued employment obligates the new hire to take affirmative steps to resolve any discrepancies identified by the system. If you consider a position that is not within the area you reside you will be responsible for all cost that incur. H-1B or TN status) for this employment position, Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site goals, Detailed knowledge and understanding of cGMPs and global compliance expectations for aseptic processing (e.g. - 30%, Drive Continuous Improvement - Supports the continuous improvement of the Quality function by identifying and resolving gaps/waste in quality systems, tools, and processes. ), Interpersonal skills including ability to effectively influence others, Technical writing and presentation skills, Ability to prioritize and attention to detail, Collect environmental and water samples at client facilities using sampling protocols and associated documents, Perform Harmonized Microbial limits testing and Qualification, Conduct Bacterial Endotoxin testing of water samples and product using Gel clot & kinetic Turbidimetric Methods, Conduct Water Activity and Bioburden testing, Routine environmental monitoring (viable and non-viable particulates), Water Analysis (Total Viable Count, absence of coliforms, Total Organic Carbon and Conductivity), Maintain Stock Culture for routine testing, Sterility check incoming media and perform Growth Promotion testing, Enter samples and data into Electronic Notebook and prepare required reports, Initiate and participate in investigations and CAPAs and ensure timely completion, Order supplies and maintain laboratory and equipment, Adhere to quality control and safety procedures, work in an organized manner, and comply with client site requirements, At least one year GMP or manufacturing environment experience, Experience with SAP ordering system and TrackWise investigation system, Bachelor's degree in biology, chemistry, or other related degree concentration, or equivalent directly-related experience (two years of directly related industry experience is equivalent to one full-time year of college in related major), At least 1 year of directly related experience, Calculate, evaluate, review, and properly communicate data verbally and in written format, Perform aseptic microbiological testing of samples including Bioburden, LAL, Conductivity, and Endotoxin on raw materials, manufacturing components, and lab supplies, Record and document data according to regulatory requirements, Aseptically collect and submit environmental monitoring (EM) samples at client facility using sampling protocols and associated documents, Set up and validate new analytical procedures or related processes used by the department; perform benchwork for validation studies, Calibrate and clean equipment as necessary, Ability to access and use computer programming including PC software, Read, understand, and follow the principles of methods and procedures used in assigned work, Prepare documents (including, but not limited to analytical procedures, standard operating procedures, explanations of data, investigations, and protocols) in a written format, Work overtime and/or adjust working hours when necessary to meet client requirements, Train personnel to perform laboratory operations, Operate and maintain sophisticated instrumentation (isolators, sampling equipment, environmental monitoring equipment, identification equipment, particulate equipment), Troubleshoot and repair laboratory equipment under direct supervision and assist in investigations, Review testing using manual or computerized data systems while complying with all compendial and regulatory requirements, Work on special projects with general supervision and draft reports with assistance from others, Bachelor's degree in microbiology, life sciences, or other related degree concentration, or equivalent directly-related experience (two years of directly related industry experience is equivalent to one full-time year of college in related major), At least one year related laboratory experience (microbiology and environmental monitoring in a GMP facility preferred), Create and design new methods to support expansion of laboratory capabilities and improve/solve existing method deficiencies, Develop Standard Operating Procedures (SOPs), Expertise in emerging technologies for biological threat agent analysis, Design, Lead, and oversee research and development and method development efforts, Develop experimental designs and test plans, Train on molecular biology and/or microbiology topics including sample collection/analysis/ threat-agent production, Expertise in current and emerging bioanalytical tools and techniques, A Ph.D. in science (e.g., biology, biochemistry, microbiology, clinical laboratory sciences, genetics, microbial ecology, microbial genomics, molecular biology, or forensics) coupled with 5 years directly relatable experience, 10 years of experience working in the Intelligence Community (IC) environment, Must be able to successfully pass a skills assessment, Extensive experience working in and/or leading operations, research and development, and/or method development in a microbiology, biology, clinical, genetics, or forensic laboratory, Eligible for both US Tourist Passport and US Official Passport, Understanding of basic biology and microbiology concepts, Follow methods to support expansion of laboratory capabilities, Follow and properly use Standard Operating Procedures (SOPs), Review, evaluate, and analyze data from samples and provide database entry support, Experience and/or knowledge of emerging technologies for bio threat agent analysis, Provide technical support involving research and development and method development efforts (including laboratory work as needed), Collect potential microbial or bio threat DNA samples from materials using approved procedures designed to minimize the possibility of sample contamination, All samples shall be properly packaged, marked and stored in preparation for extraction, Familiarity or use of the following instruments and equipment, A Bachelor’s degree in science (e.g., biology, biochemistry, microbiology, clinical laboratory sciences, genetics, microbial ecology, microbial genomics, molecular biology, or forensics) OR five (5) years directly relatable experience, One (1) year of experience working in the Intelligence Community (IC) environment, Currently have an active DoD Secret security clearance, Previous experience working in a microbiology, biology, clinical, genetics, or forensic laboratory performing analysis of biological samples, including sequencing, Deployment experience in an analytical/operational environment, Develop new methods to support expansion of laboratory capabilities and improve/solve existing method deficiencies, Developing Standard Operating Procedures (SOPs), Experience and/or knowledge of emerging technologies for biological threat agent analysis, Lead and support research and development and method development efforts (including laboratory work as needed), Provide training on molecular biology and/or microbiology topics including sample collection/analysis/threat-agent production to Junior staff, Identify and research new and emerging technologies for biological threat agent analysis, and provide recommendations on platforms or instrumentation regarding their suitability for specific needs, Understanding and knowledge of current and emerging bioanalytical tools and techniques, Collect potential microbial or biological threat DNA samples from materials using approved procedures designed to minimize the possibility of sample contamination, Generate DNA sequences from biological materials, Experience and expertise in using, maintaining, and troubleshooting the following types of equipment and instrumentation, A Bachelor’s degree in science (e.g., biology, biochemistry, microbiology, clinical laboratory sciences, genetics, microbial ecology, microbial genomics, molecular biology, or forensics) coupled with 10 years directly relatable experience OR a Master’s degree, 5 years of experience working in the Intelligence Community (IC) environment, Must be able to successfully pass all medical requirements for deployment, as needed, Experience working in a microbiology, biology, clinical, genetics, or forensic laboratory performing analysis of biological samples, including sequencing, Performs QC Lab activities by following relevant present SOPs, Prepares and revises QC relevant SOPs, associated training materials, Prepares reagents that are to be used for analysis, Records analytical data in notebooks, logbooks and Specification and Quality Assurance Report and laboratory analysis forms accurately. 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