Initiate and complete CAPAs and change controls, Must have good technical writing skills and high attention to detail, Ability to train staff and oversee testing operations by lower level analysts within the laboratory, Perform calibrations and some troubleshooting of lab instrumentation, Microbiological SME for internal and external regulatory inspections and audits, Strong collaboration skills with lean Laboratory knowledge and experience, Write and execute new microbiological methods, Assist with the execution of validation protocols and reports, write analytical procedure SOPs and equipment SOPs, Perform routine testing while following validated procedures for raw materials, in process samples, facility / environmental monitoring, bulk-drug substance release and stability testing. - 30%, Drive Continuous Improvement - Supports the continuous improvement of the Quality function by identifying and resolving gaps/waste in quality systems, tools, and processes. Established as a Subject Matter Expert (SME) in Microbiology, Sterilization, Sterility Assurance, and Manufacturing Processes as they relate to the above areas, Demonstrated expert knowledge of at least two of the following sterilization techniques: gamma irradiation, ethylene oxide, hydrogen peroxide gas plasma, moist heat, or dry heat, and possess a working familiarity with the others, Demonstrated proficiency to maximize the biocompatibility of products using industry guidelines and advanced testing technologies, Demonstrated ability to complete complex tasks using creativity, personal experience and good judgment. Rehydrate organisms and maintain stock cultures used for growth testing. Prepares and executes cleaning & sanitization validations, + Effectively bring together various individualsand departments for common effort, Prior experience in Quality Control laboratory setting, Interacts effectively with business partners to communicate and resolve issues and gain a clear and accurate understanding of each other’s requirements, Pharmaceutical Experience and/or experience with aseptic technique and indoor environmental sampling, Basic knowledge of spreadsheet, database and word processing computer skills, Demonstrated experience working with microbiological cultures and use of aseptic techniques, Prior experience with testing procedure noted above, Operate and maintain laboratory equipment, including but not limited to incubators, autoclaves, ovens, vacuum pumps; assist with qualifications and validations, Prior experience working in GMP environment/HACCP, Lead training on all document modifications prior to effective date, In depth knowledge of Good Manufacturing Practice and Good Laboratory Practice, Support site/product investigations as required. 3. Tap/click on the one you wish to review or edit. Develop and share expert functional knowledge, educating individuals across both NPD and the wider AWC team. Your uploaded documents may take several hours to clear the virus scan process, Your Résumé - You are encouraged to use the USAJobs online resume builder to ensure that all required information is in your resume. 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. When combining education with experience, first determine the applicant's total qualifying education as a percentage of the education required for the grade level; then determine the applicant's experience as a percentage of the experience required for the grade level; finally, add the two percentages. This is why you need to provide your: The section work experience is an essential part of your microbiologist resume. Ensure practices are in place and standardized in our field and Corporate operations, including plants, suppliers and contract packers, to assure that stable conditions exist that prevent unacceptable microbiological contamination. Follow the on-screen instructions provided by USA Staffing and respond to ALL questions presented to you. A competent and focused Microbiologist who can carry out complex tests, review data and write up reports to advise whether the results are valid against relevant testing protocols. ), Test raw ingredients, finished products and environmental samples, Testing of finished products using pour plate, petrifilm and rapid micro test methods for sterility, Monitor plant and laboratory environment by taking swabs, air and water samples at set frequency, Participate in the AOAC proficiency testing. - Instantly download in PDF format or share a custom link. Bachelors is required, 1 to 5 years of R&D (technical, product application development) experience in meat/food science. No need to think about design details. 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. Conducts swabbing of manufacturing equipment and surfaces to validate sanitation SOP's - 50%, Project and Lab Support -- Supports microbial inoculated challenge studies to ensure formulations are stable and robust. Microbiologist Resume. Tap/click on your name in the top-right corner, then select "Applications", You will see a list of the most recent applications you have submitted. The U.S. Department of Health and Human Services is an E-Verify Participant, A background investigation may be required, Incentives may be authorized; however, this is contingent upon funds availability. Specific vision abilities required by this job include close vision and color vision, Work with QA team to develop and implement process control initiatives, Perform equipment evaluations, maintenance, and calibrations (ICPs), Work with other departments in leading/teaching/educating EE’s in GMPs and HACCP, Assist with weekend and holiday coverage as needed, Maintain safe work environment and support safety programs, Monitor incoming raw materials and maintain traceability program, Review and approve daily paperwork for all lines, including follow-up w/ resources for missing documentation, Support warehouse and production with product holds, records, dispositions and root cause analysis, Assist with consumer complaint processing, reporting, and analysis for all aspects of the plant, Assist with all plant Quality initiatives and projects as needed, Perform microbiological testing on in-process, finished product and spring samples, Perform hygiene audits for all departments and assist resources with corrective actions, Conduct chromatographic and spectroscopic analysis for bromate and acetaldehyde, Serve as silicone emulsions microbial expert for the business, Maintain and advance key control strategies and capabilities focusing on fundamental, data driven microbial science, Develop proactive microbial risk mitigation strategies in conjunction with the GMP process expert(s), Evaluate and integrate best practices related to microbial risk during the product development process, Establish and leverage external linkages to maintain best in class practices for microbial control, Perform efficient/reliable microbial testing in accordance with regulatory or customer guidelines (including microbial challenge testing, water analysis, chemical water analysis, environmental monitoring, raw materials and finished goods), Drive technical and fundamental microbial science understanding, best practices, and continuous improvement regarding controls and testing capabilities through global standardization, Work with production facilities to provide support for microbial root cause investigations through data monitoring and analysis, Support production transfers utilizing a risk based approach, Responsible for identifying appropriate tests and conducting, reviewing, and verifying routine microbial testing results, Provide suitable preservative recommendations throughout product development life cycle, Provide technical assistance for troubleshooting of customer issues, Support upgrades to the corporate microbiological control program for emulsions across all key areas, The Dow Chemical Company does not offer relocation if the position is offered to someone who lives outside the area or reimbursement for travel to and from interviews. 999 Any Town, NY 99999 Phone: 999-999-9999 Proficiency with Word and Excel. Browse our database of 1500+ resume examples and samples written by real professionals who got hired by the world’s top employers. resources to support laboratory activities, Takes part in preparation, control and implementation of SOPs related to the function, Planning and review of testing methods according to GMP and internal regulations, Revision of test specifications and checking compliance of test specifications with protocols, Conduct investigations, recommendation for corrective and preventive actions, Reading and registering the microbiological test results, Execute microbiological analysis according to the relevant SOPs, procedures and national standards. Buddy System), Ensuring that all Quality Systems within the department are adhered to on a daily basis, Ensuring correct labelling of laboratory reagents and samples, Troubleshooting any erroneous analytical data obtained (Involvement in Lab Investigations Reports), Helping to ensure laboratory SOPs and specifications are kept up to date and in a state of compliance, Training other laboratory staff as requested and appropriate, At least 3 years' experience working within a pharmaceutical cGLP environment (IMB and FDA approved), At least 2 years' experience working in a Microbiological testing role, Environmental monitoring of cleanrooms for viable air, viable surface and particulate in line with ISO 14644 standards, Monitoring of utilities including all grades of water, and where necessary, compressed air, Co-ordination of samples for bioburden and endotoxin testing, Trending and interpreting all associated data. Monitor external regulatory trends that have the potential to impact Consumer Health preservation, Ensure Category R&D teams are aware of microbiological issues and risks associated with category products and that these issues are addressed in product development programs, Ensure compliance with Quality systems as well as health and safety requirements for all work conducted, Providing coaching and mentoring for microbiologists and personnel involved in microbiological decision making, Be willing to work in a team-based environment, Be able to work with limited direct supervision, Have good problem solving/organizational skills to meet frequent changes in immediate priorities, problem solving skills, and understanding of various computer software programs required, University degree in Microbiology, or related science, A minimum of 3 years microbiology laboratory experience in pharmaceutical industry, Sound knowledge of practical microbiological assays, Sound understanding of USP, EP, BP, GMP, cGMP and ICH guidelines for microbiological analysis, Computer proficiency with MS Office programs, Able to coordinate and motivate a team towards a common goal, Able to work independently and to coordinate several activities simultaneously, Able to interact with all levels of management, suppliers and clients, Good communication, negotiation and interpersonal skills, Works well under pressure, challenges status quo, Apply cGLP, cGMP, ANSI, AAMI, ISO, FDA, EPA, and USP guidelines to the bioburden, cytotoxicity, bacterial endotoxin, and biocompatibility analysis of orthopedic implants and surgical instruments, Actively support new product development activities, Participate in the development and improvement of the manufacturing processes for existing and new products, May lead in the development, review and approval of sterilization process and equipment validation/qualifications (IQ, OQ & PQ), Point of the contact for suppliers for new process development, quality issues and process improvements for assigned projects, Support product transfer to other plants/facilities, Participate in or lead continuous (breakthrough) improvement activity and process re-engineering projects, Execute and maintain the dose audit and bioburden testing program to support EO and radiation sterilization. A Senior Laboratory Technician takes charge of leading the overall Laboratory procedures that are technical in nature. Department manager (Environmental Monitoring, Microbiology Testing, and Raw Material Sampling) for ophthalmic products in tube and bottle applications. Our microbiologist resume sample demonstrates how a specialist in this field can use the conventional resume sections to provide prospective employers with all the information they need to know. JUST POSTED: 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. ü Serial Dilution Method for Bacterial Cultures. Experience must include performing culture work ups and reports including identification and susceptibility testing on actual patients (as opposed to food ,environmental, or research), An extensive knowledge and understanding of clinical microbiology, Good working knowledge of basic chemistry and of bio-chemicals used to identify microorganisms, This individual must possess the interpersonal skills to be able to work as a Team contributor, and individual contributor. Download Microbiologist Resume Sample as Image file, Develop or assist in developing experimental designs and test plans, Schedules and prioritize work for staff and develop training and analyst qualification programs to perform assays under cGMPs, Provide technical support to R&D for new product development, Perform laboratory work on weekends and holidays on a rotating basis with other members of the department, Prepare in-depth risk assessment for all new product development and provide Microbiology expert summary for Regulatory submission, Provide technical assistance to external and internal customers regarding microbiological enquiries, Lead and participate in the development and improvement of processes for existing and new products, Assists in developing, writing and updating, laboratory SOP’s and approved procedures, Be a point of contact for suppliers for new process development, quality issues and process improvements for assigned projects, Assist in provide training on molecular biology and/or microbiology topics including sample collection/analysis/threat-agent production, Duties may be executed in a CONUS or OCONUS laboratory and include performing analyses of samples that have been collected, Makes and records observations, performs calculations, collects and may assist in preparing data for evaluation. US FDA, EU, etc. Candidates should include all pertinent information regarding their research accomplishments, e.g.list of publications and presentations, Cost of Living Allowance (COLA): Yes, 4.22%, Manage the transfer and provide technical oversight of Microbiological methods from Development to QC (validation of methods and tech transfer of methods, including comparability), Establish user requirements for purchase, qualification of Kite’s QC equipment and work with internal and external resources to maintain equipment in an optimal state, Develop, revise and review SOPs, qualification/validation protocols and reports, Conduct investigations regarding out of specifications (OOS) results and address and manage deviations related to micro procedures, Monitor the GMP systems currently in place to ensure compliance with documented policies, Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate, Gather metric information for use in continuous improvement of areas of responsibility, MS or higher (Microbiology, Food Microbiology or related Major) preferred. Microbiologist/Quality Assurance Resume. Incentives include the following: moving expenses, recruitment or relocation incentive; student loan repayment, superior qualifications appointment, creditable service for annual leave for prior non-federal work experience or prior uniformed military service, etc, Financial Disclosure Statement required: NO, Testing of samples such as raw materials and manufacturing products, Prepares solutions, suspensions and media to perform essential laboratory procedures using aseptic techniques, Reports results of assignments, maintains and performs related record keeping in compliance with approved regulatory policies and standards to meet quality and accuracy requirements, Demonstrates good housekeeping practices to minimize data mix ups, potential laboratory contamination and safety hazards, Follows and complies with all appropriate operations and testing procedures, GMPs and safety and health requirements as applicable, 1-3 years of experience preparing solutions, suspensions and media to perform essential laboratory procedures, Bachelor’s Degree of Science preferably Biology, Microbiology, Medical Technology and Food Science or other closely related discipline with extensive significant experience can be considered in lieu of a Bachelor’s degree, Must have experience working with non-sterile products, utilizing aseptic techniques and knowledge of proper laboratory safety procedures, Adaptability/cooperation; Ability to maintain effectiveness during major changes in work tasks or the work environment; adjusting effectively to within new work structures, processes, requirements or cultures, Continuously look for ways to be more efficient, while maintaining high quality standards, Deliver true, accurate results in a timely manner, Skilled expertise and diligence in using aseptic technique, Technical knowledge and expertise in the use of molecular biology instrumentation for qualitative assays, and phenotypic techniques for quantitative assays, Skilled in sample preparation, homogenization and serial dilutions, Maintains documentation of microbiological results and testing traceability in the Laboratory Information Management System (LIMS), When appropriate, help to write/create documents for, and always follow laboratory quality management systems ISO 17025 m Mars Global Laboratory Quality Management System, Work as a team player including open and honest communication, respecting confidentiality with any laboratory information, Masters the key scientific principles associated with Microbiological assays, Understanding of microbiological testing techniques including FDA BAM testing methodologies, Demonstrates knowledge and understanding of laboratory safety, chemicals, Demonstrated experience and skill with Spreadsheet software (MS Excel preferred), Word, ELN, and Laboratory Information Management Systems (LIMS), Excellent organizational skills to adapt to fluctuating workloads while maintaining attention to detail, Excellent interpersonal skills and the ability to work independently or as a member of a team, Flexibility to changing priorities and timelines, Bachelor’s degree in microbiology or related science (natural or food sciences), 2 or more years’ experience with microbiological analyses in food or related industries (advanced education may partially substitute for required experience), Experience working in a production lab environment, Candidate must demonstrate strong technical understand of methodology and systems of quality testing, scientific principles and practices. Bachelors Degree required. 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. ), Prefer prior successful experience managing processes/projects, Good verbal and written business communication skills, Ability to multi-task and work quickly while maintaining quality and accuracy, Understand sample and reagent preparation processes and calculations including dilutions and percent solutions, Ability to follow analysis protocols and approved standard methods, understand the effects of protocol deviations on analytical results, and monitor the results for validity, Ability to assess multiple microbiological protocols and determine the appropriate method of analysis to obtain accurate and valid results, Ability to follow quality control and quality assurance protocols to ensure the validity of test results and safety of the work environment, Ability to collect data, interpret findings, draw valid conclusions, and identify discrepancies and/or invalid results, Ability to apply advanced mathematical concepts such as exponents, logarithms, and advanced Algebraic equations. water system through routine sampling and testing. Familiar with cleaning and sanitization validation approaches. Resume format plays a vital role while creating a job-winning resume. With ever increasing number of colleges and passing graduates, its very crucial to stand out of the crowd to land a dream job. B.Sc microbiology is one of the most sought after branches in graduation. In conjunction with the QC Micro & Process Support Team Leader identify, record and resolve any microbiology related product quality deviations, Excellent Microsoft-based computer skills to complete and update detailed specifications and reports, create pivot tables, etc, Very good Czech/Polish and English language skills, Stong interpersonal skills together with the capability to develop strong relationships, Work well in a team environment and possess good communication, data analysis and scientific presentation skills, Strong investigational skill, working knowledge of microbiology assay development and validation, Accurately assess problems and effectively and efficiently arrives at effective solutions, Creative/analytical problem solving skills with the ability to apply innovative approaches to understanding and resolving complex problems, Experience with Solid dosage products and powders testing, Experience of Bioburden/Sterility Validation would be an advantage, Effectively communicates testing progress or project status to Micro Supervisor, Familiar with basic lab skills of aseptic techniques, Communicate microbiology and chemistry results effectively to all levels of the organization, Work effectively with Production personnel to ensure quality parameters are met and food safety is not compromised, Provide guidance to plant personnel, as required, ensuring good manufacturing and good documentation practice, Collaborate and communicate effectively with peers and management, Multi-task, work effectively and complete projects in a fast paced environment, Effectively and efficiently troubleshoot and resolve technical issues, Statistical skills: Design of experiments, Variance analysis, Previous experience and demonstrated knowledge of aseptic techniques, Ensure compliant sterilization validation, revalidation and dose audit activity for Gamma and Ethylene Oxide product sterilization cycles at multiple sites, Ensure cleaning practices are validated, effective and up to date, Responsible for direct management of Validations lab, lab analyst, and prioritization of testing schedule in LIMS, Demonstrated strong data-driven decision-making and problem-solving capabilities, Demonstrate knowledge of good documentation practices, lab note recordkeeping and concise report publishing, Experience with pluripotent cells, experience working under GLP/GMP, Support design verification and validation test requirements that ensure appropriate objective evidence is available to support acceptance criteria, Operates and maintains laboratory equipment, ensures its proper operations; operates analytical and other instruments, Comfort around higher management – Able to articulate confidently, concisely and effectively to higher management, Communicate effectively in both written and oral formats within the lab as well as with external customers and business partners, Computer Skills - Knowledge of database software, Internet software, spreadsheet software, and word-processing software, Demonstrated skill in project management ideally within a Consumer Healthcare organisation, Industrial experience in biopharmaceutical industry, such as Microbiology, Biology, or related field experience, Have Experience in test and equipment validation, Laboratory experience in Quality Control or equivalent combination of education and experience, 6) Ability to communicate effectively in English, BA/BS related with 5+ years experience or MA/MS 1-2+ years related experience, Experience in vivo/in vitro laboratory experience, Molecular Biology skills, such as PCR is advantageous, Understanding of Good Lab Practices, environmental monitoring, and trending of data, Responsible for completing various tasks within the lab environment, scheduling tasks depending on given priorities, and meeting communicated deadlines, Experience in any of the following is essential: Endotoxin, Bioburden, Environmental Monitoring, Sterility, Sample Management, Demonstrated knowledge in microbiological techniques; including gram stain, media preparation, streak plating, and microbial identification methods, Demonstrated ability to maximize the biocompatibility of products using industry guidelines and advanced testing technologies, Pharma lab experience performing micro testing on water, pharma chemicals and drug products, Monitors the plant’s environment, identifying potential problem areas. 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