Specialist areas include: 1. medicine 2. healthcare 3. research 4. agriculture and food safety 5. environment and climate change. The employee is also required to use a computer, and communicate with peers and co-workers, During the course of regular assigned duties, the employee may be required to properly utilize personal protective equipment including but not limited to: safety shoes, safety glasses, goggles, hard hats, air purifying respirator or supplied air respiratory protection, The employee must be able to lift 10 pounds per job requirement, Plate patient samples on required culture media by specimen source, Setup and interpret confirmation testing as appropriate, Perform aerobic, anaerobic, and fungal cultures, Workup samples for the presence of parasites, Perform rapid PCR testing for C-Diff and MRSA, Run and interpret antibiograms for isolated pathogens, Run quality control and pass all government mandatory proficiency testing, Perform instrument maintenance and troubleshooting, Provide physician consultation on complex cultures, Work with the infectious disease specialists, Follow safety protocols to protect against avoidable exposure to pathogens by using the biologic hoods and other safety equipment as designed for the microbiology laboratory. In addition, he/ she will be supervising a team of lab analyst/ technicians, Provide support to the site Sterility Assurance Group, This role is responsible for assisting the sterility assurance specialist in setting the standards and systems for bio-burden and its control, Ensuring that the bio-burden data is accurate and representative and that the process is adequately assessed and documented, Ensuring that the Biological Indicator validation is accurate and fully compliant with the sterilization monograph and site procedures including proper storage, assessment, use and measurement of the BI’s used in the validation process, Assessment/ approval of changes with regard to sterility assurance/ bioburden control systems in conjunction with the sterility assurance specialist, Provide leadership and direction in all areas relating to the sterility assurance of the product, Ensure clear communication to all stakeholders and customers, Ensure systems are in place to such that all site microbiological activities are carried out in compliance with product license commitments, cGMP and Quality standards, To lead all microbiological discussions during regulatory inspections and internal audits, Anticipate and plan for future requirements within remit, including such aspects as procedural requirements, compliance requirements, efficiency developments and anticipated changes needed to reflect future demand for services from the departments, Ensure safe practices are adhered to at all times in the laboratory, Identify and support training needs required for the site and the QC team, Ensure clear and measurable goals are set in a timely manner for both QC and BU teams, To take the responsibility to engage employees to enable the delivery of the departments functional goals including financial and people development, Provide support to, and deputize for, the QC Manager as required, Provide support to the QC Management team as required, Foster an environment of continuous improvement and providing leadership in this area by identifying and implementing practices to deliver efficiency, cost reduction, quality and service level improvements across the site, Responsible for the QC Technical Support & Release Team, Support the development of the deputy site microbiologist role and work with these personnel to develop and implement continuous improvement projects from a microbiological perspective, Provide support and technical expertise to the site to ensure people and technical skills are in place to implement new technologies and apply best practice in Microbiological techniques and systems, To ensure that all company policies are adhered to by self, Primary degree in Science essential supported by a sound technical background in Microbiology or equivalent knowledge and experience, Proven years microbiology expertise in a regulated Pharmaceutical industry essential, Excellent interpersonal and communication skills with good leadership abilities, Experience of direct interaction with Regulatory Bodies (e.g. Candidates must attain a qualifying rating on each portion of this examination, Associate degree in biology, microbiology, chemistry or other related field required, Previous laboratory techniques such as pipetting, aseptic techniques, Good organization skills and ability to multitask are desired, Strong verbal and written communication skills and ability to work effectively on teams is a must, Ensure plant compliance with all Hygiene, HACCP, Sanitation and GMP requirements, Microbiology- understanding the program and being responsible for all micro activities to sustain the program (sampling, plating, reading, Lab ICP), Troubleshooting microbiological issues resulting from results of processes and CIP activities, Supporting and troubleshooting QA issues on the production line, Sensory – setting up finished product and odor panels in accordance with sensory program, Performing calibrations on measuring and monitoring equipment; ozone sensors, pH meters, conductivity meters, TDS and turbidity meters, Monitoring the quality of the product on the 1st shift, by line releases, duplicate checks and incidence reports, Water treatment testing on incoming water from city and springs, including reverse osmosis system operations, Customer Complaint testing and troubleshooting, Testing and verifying equipment used for water treatment on city lines and process lines, Monitor and advise when CIP activities and external cleaning is needed, Degree in Microbiology, Chemistry, Biology or related science or demonstrated equivalent experience in microbiology lab preferred, Flexibility for Weekend Work when Needed for Reading Plates and Quality Support for Saturday or Sunday Production, Physical Capability of lifting more than 50 lbs, 1-3 years experience in microbiology plating methods highly preferred, Knowledge of RO, CIP, and Cleaning Systems, Perform microbiological testing (endotoxin, bioburden) for water, Perform microbial characterization (gram stain, catalase, oxidase, and coagulase tests), Prepare and send out samples for microbiological identification, Sampling, qualitative and quantitative microbiological examinations including, but not limited to testing EB, AMC, Staph, B. cereus, yeast, mold, pH and other related analysis using both direct streak and pour plate for incoming materials, finished product and investigations, Sampling and testing as applicable utilities systems including pH, sensory and microbiological analysis, Prepares, reviews, and reports results of microbiological analyses; maintain and document records in accordance with established procedures, Maintenance of the environmental monitoring program including sampling, testing, data entry and reporting results, Ensure maintenance and calibration program for analytical instrumentation and equipment within the laboratory, Cleans-up and general maintenance of laboratory and work area, 1-2 years’ experience in a microbiology laboratory or setting is preferred, Effective communicator with training, facilitation, and supervisory skills, Must be capable of working with minimal direct supervision and have strong prioritization, interpersonal, and self-initiative skills, Computer skills to include proficiency with the Microsoft Word and Excel required. If you are currently, or have been within the last 5 years, a political Schedule A, Schedule C, or Non-career SES employee in the executive branch, you MUST disclose that to the Human Resources Office. Other duties may be assigned, Performs routine microbiological testing of products and raw materials according to SOPs and Methods, Documents routine procedures following laboratory and company guidelines, Reviews and approves work performed by technician and peers, Develops and validates microbiological test methods for sterility testing, bacterial endotoxin testing, antimicrobial effectiveness testing, and bioburden testing, Perform filter validation studies including Bacterial Retention Testing, Performs antibiotic assays per appropriate USP method, Read and interpret product labeling instructions (package inserts) in reference to appropriate dosage and administration guidelines, Prepare protocols and execute testing for Microbiological in use stability studies on drug products under development, Coordinates and tracks Microbiological testing necessary for ANDA submissions and prepares reports for submissions including Microbiological Product Development Reports, Antimicrobial Effectiveness Testing Reports, and Bacterial Retention Reports, Approves product specification for release in management absence, Prepare and review protocols in support new product development, Assist on the generation of outside source information retrieval and-evaluation in support of special project work, Bachelor's degree (B.S.) The incumbent must be able to interface positively with peers, clients, regulatory agencies, vendors, and staff from other departments. Ensure that your email address is. This is an actual CV example of a Quality Assurance/ Microbiologist who works in the Quality Assurance/ Microbiologist Industry. If authorized, certain incentives will require you to sign a service agreement to remain in the Federal government for a period of up to 3 years. LiveCareer’s CV Directory contains real CVs created by subscribers using LiveCareer’s CV Builder. full synopsis (usually around two to three pages) of your educational and academic background and related information Monitor external regulatory trends that have the potential to impact product preservation, In collaboration with stakeholders in R&D and manufacturing, provide technical input to project teams on microbiological issues throughout the project lifecycle, Ensure that state of the art microbiological test methods are employed in the CH organization, with the goal of continual improvement of effectiveness and efficiency, Ensure application of robust and valid scientific approaches to all work conducted in internal and external laboratory networks. Prefer minimum of 2 years of microbiology laboratory experience and experience with aseptic technique, He/ she is also required to work on projects assigned to him/ her by his/ her immediate supervisor and eventually able to provide recommendations in project attachments and lead/ coordinate activities in assigned projects, To train/ coach Lab Analysts, and if required, other stakeholders, He/ She may be required to perform laboratory testing when necessary. Ensures company food products and business initiatives meet Food Safety and Regulatory requirements, Collaborates cross functionally and globally to create alignment of microbiological programs across the company, Recommends and oversees content updates to department or company resource manuals, standards manuals, training programs, and operational excellence tools. 10, Performs recertification of clean rooms and plant systems. If you cannot complete the Application Package online, you may fax all of your materials. May have the opportunity to lead a small team, Knowledge of and experience with microbiology laboratory testing for medical device company is required. This will require effective interfacing with not only those in R & D, but also others in manufacturing, QA/QC, regulatory, marketing, and commercial, Evaluating and implementing new technologies to enhance current capabilities, Providing technical reports and presentations to enable company-wide and industry adoption of new methodologies, Limited travel to Monsanto field and manufacturing sites to support testing of existing commercial. (Including: performing specific tests, expressing the results in a described manner, monitor response time), Provide Month end statistical information to QATM, Process Documentation Supervisor and Plant Manager, Maintain registration of the laboratory permits, Maintain clean equipment and laboratory environment, Evaluate and authorize the stability of raw materials and finished product, Review all laboratory programs regularly and keep records, General support of plant production and quality assigned by plant leadership, Attend all safety meetings, report any safety incidents/accidents and understand and follow all Company and Plant Safety policies and Procedures, Trained in the Kerry HACCP program in order to identify critical steps and other instructions critical to effective implementation and maintenance of the Food Safety Plan, Provides support for the current SQF System, Manager micro laboratory supplies (inventory on a set frequency), Communicate with lab suppliers and order supplies when necessary, Leadership in the fundamentals of lab safety, equipment and testing procedures, Provide support to plant employees in aseptic sampling process and food safety, Meet the efficiency and cost targets of the department, Evaluate product from shipment or production, Maintaining technical proficiency through participating in training and development courses as provided by LMS, Adhering to the ethical standards as outlined by Kerry USA, Participation in continuous improvement projects and suggestions organized by plant management, Participation in cost savings initiatives, Participation in courses provided by GFTC, Silliker or other leaders in microbiology or organized by the Corporate Microbiology Task Force, 3 years of experience in the microbiological laboratory, Full understanding of biohazards and laboratory safety, Collect relevant microbiologically focused data to evaluate current plant sanitation procedures and recommend corrective actions to reduce the identified hygienic risk, Manage plant focused hygienic investigations and suggested documented corrective actions, Evaluate plant sanitation activities / procedures and recommend relevant continuous improvements, Evaluate microbiologically focused concerns and recommend corrective actions, Provide reports to senior management on the hygienic performance of company owned plants and contracted manufacturing sites, Two to three years of food plant sanitarian experience with an emphasis on microbiological evaluations and controls, Previous food industry experience, which includes HACCP, SQF (or other GFIS), and FSMA preventive controls, Knowledge of effective sanitation protocols and prior training in fundamental quality assurance, Perform all functions relating to sample preparation through sample completion, Provide training on applications as needed, Plan for assigned workload on a daily basis and effectively schedule multiple assignments, Maintains a clean and safe laboratory work environment, Facilitates the work flow for other microbiologists in the lab, Reviews sample login prior to samples testing being initiated in the lab, 1-3 years of experience in a Microbiology Lab with at least 1 year in a Medical Device environment, General knowledge of cGMP’s/ISO 13485: 2003, Computer Software Knowledge (Word, Excel), Bachelor’s degree required in Microbiology or other related science, 4+ years of experience in the medical device/pharmaceutical industry pertaining to microbiology/sterilization with a Bachelor’s degree, 2+ years of experience in medical device/pharmaceutical industry pertaining to microbiology/sterilization with a Master’s degree, Understanding and application of current sterilization standards, such as ISO 11135 and ISO 11137, Knowledge of sterilization technologies and processes, especially EO, steam, and radiation, Familiar with FDA 21 CFR part 820 and 210 and ISO 13485, Master’s degree in Microbiology or other related science preferred, Ability to develop, validate, implement and defend business processes that impact sterilization. This may include support to new product introduction, particularly sensitive beverages, Provide on-site training when requested by BUs, Support day-to -day functioning of EASC through basic understanding of beverage analysis and beverage parameters, Support roll out and participate in Plant chemist training programs, Conduct Internal audits for EASC as required, Participate in third party lab assessments as needed, Participate in proficiency testing as required, Investigative mindset, analytical & logical thinking, Understanding of problem solving techniques, Development & optimization of test strategies/ new technologies and adaption/ integration of new standards in compliance with regulatory requirements across sterilization/ microbiology, Lead the development of solutions to complex technical problems related to product, processes and cleanrooms using problem solving techniques and methodologies, Collaborate and partner with NPD functions to define, execute and deliver on NPD requirements ensuring robust and capable processes/ tests/ methods, Drive functional excellence across sterilization and microbiology relating to cleanroom optimization and sterilization technologies including EtO, E-beam, Gamma and Steam Sterilization, Represent Microbiology and Sterilization Services at a site level and externally on global teams/ technical forums, Assist other scientists through consultation on preservative selection based on prior knowledge, Assists in the review, revision and instruction of training materials for new development staff members, Participates in meetings with the international microbiology community and professional trade organizations, Periodically review results, write reports and present project results to development teams, Oversees a safe and orderly laboratory environment, Solid understanding of GLP, USP, PCPC guidelines, AOAC Official Methods of Analysis, and ASTM methods, Demonstrated ability to lead and work well with teams, Experience with aseptic techniques, various media and culturing methods, Develops, implements, manages and tracks effectiveness of an integrated microbiological program, including systems, standards, procedures, measures and tools to assure that food safety, quality, sanitation and regulatory requirements are met for food products and operations, Leads cross-functional project teams and/or sub-teams that require and develop microbial specifications and standards and procedure improvements, Supports the management of potentially serious product incidents through science based food microbiology approach, Analyzes quality metrics, customer feedback and workgroup input. Evaluate alternatives, propose and recommend solutions to problems. Tracking and trending data as well initiating and writing investigations, Using excellent technical writing experience write procedures, protocols, final reports, deviations and investigations, Submission and tracking of LAL samples, timely review and release of results. I have a B.S. You can make changes to add or remove supporting documents before being transferred over to FDA's USA Staffing system where you can continue making changes to your responses to the occupational questionnaire. Ability to use root cause analysis. Perform microbiological methods such as bioburden testing, microorganism identification, and endotoxin testing, Support the Sterilization Microbiologist in assuring consistent microbiological methods across the company, Provide clear written procedures for routine microbiological methods, Perform other duties as assigned based on business needs, Education or Equivalent Experience: Bachelor's in Microbiology or similar degree, Demonstrated accomplishments in performing Sterilization and Microbiology activities, Experience in supporting sterilization activities, BSc Degree in Microbiology or related sciences with significant industry experience OR MSc Degree in Microbiology or related sciences, Ability to apply scientific principles and techniques to assigned projects, Experience of providing technical coaching to junior members, To provide Preservation expertise for the new product development in the five therapeutic categories with GSK Consumer Healthcare, To ensure the Microbiology input of the product development is in line with the relevant regulatory and legislative requirements, To provide technical training for members of internal Microbiology team as well as extended contract laboratory network (as required), Define the strategy for preservation of product developed by the Consumer Health organization. degree (biological science preferred) or A.S. degree (biological science preferred), 0-2 years of relevant experience (B.S. Problem solving leadership skills required to work with cross functional staff/site team members to drive continuous improvement, Self-motivated; works with little to no supervision, Must be able to work 8 hours per day and two weekends per month, with flexibility to work nights, holidays, and overtime as needed, 2 years Microbiological Lab Experience in cosmetic manufacturing setting, Must demonstrate proficiency in the following: Quality System computer analysis, document control system (Example: ETQ Excellence through Quality), Perform the routine/non-routine environmental monitoring for all required plants, facilities, clean rooms, hygienic areas and labs, inclusive of particle monitoring test, Perform in-process and release samples testing of excipient/ packaging components for the different drug products, semi finished drug product and drug substances. 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