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. 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. Department manager (Environmental Monitoring, Microbiology Testing, and Raw Material Sampling) for ophthalmic products in tube and bottle applications. For example, if you have a Ph.D in Neuroscience and a Master's in the same sphere, just list your Ph.D. Available in (US) 8.5x11 inches + Bleed. Generation of microbiological specifications in alignment with Compendial requirements (for US, and preferably also for EU), Hands-on experience in addressing microbiology and sterilization related topics in regulatory submissions. of Veteran's Affairs indicating you receive a non-service connected pension; AND a copy of your veteran's disability letter from the Dept. Below you'll find our how-to section that will guide you through each section of a Senior Manager resume. US FDA, EU, etc. Review data and reports for accuracy, content and adherence to quality control policies Participate in professional development activities (i.e. Maintain a network of internal contacts who can defer to for advice when appropriate, Degree required in relevant scientific discipline, Experience of microbiology research and development ideally in a commercial environment, Knowledge/experience of microbiology testing methodologies, standards and best practice, Ability to clearly convey technical information and ideas to a variety of individuals and groups with different levels of understanding, Ability to work effectively in a collaborative environment in a complex matrix organization with minimal supervision/guidance from management, Must work in strict accordance with the policies and procedures of BS EN ISO9001 and GLP, Computer literate with specific knowledge of Microsoft Office applications, Administration of the laboratory (Manage the day to day lab activities, Purchasing External Services & Supplies), Maintaining quality procedures (Control systems (Quality Manual and QC SOP’s)), Familiar with all lab techniques/methods and technology, Micro testing of Finished Products, in process and raw materials, In charge of Receipt, Storage, Retention & Disposal of Mars Samples, Manage and monitor lab equipment, cleaning, maintenance and calibration, Molecular biology techniques skills (PCR, ELISA, PFGE, sequencing), Laboratory quality control checks (daily positive control, hygiene, media, sterilization, environmental (take the swabs from the lab), personal hygiene, etc. ), 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. -Document results clearly and accurately, Interpret results by comparing against appropriate specifications or requirements, Perform Data reviews and release inspection lots in the material management system, Calibrate and maintain laboratory equipment and maintain supplies inventory levels, Participate in laboratory investigations, technology transfer, validations and R&D projects, Performs assigned Standard Operating Procedures on product/material samples under development, Evaluate new technologies, products and materials as assigned, Follow all procedures related to data documentation, laboratory safety, and good laboratory practices, Recognizes malfunctions in laboratory equipment and advises supervision or performs simple repairs, Writes, reviews and/or updates Standard Operating Procedures as assigned, B.S degree in Microbiology or related field preferred, Understanding the microbiological testing analysis, Candidate must also be able to perform several tasks simultaneously, Commitment to NWNA Aspirations and Beliefs, Supervise the microbiology team, manage its tasks, professional direction, Continuous development of the laboratory according to the GMP, Introduction of new microbiological procedures if applicable, Monitoring of the laboratory cost, suggestion for cost savings, Orders media, material and equipment necessary for microbiological analysis, Microbiological monitoring of the site environment, Make efficient use of outside (contract testing facilities, consultants etc.) ü Sub Culturing of Microbes. degree) or 8+ years of relevant experience (A.S. degree), 5 years experience in a GxP regulated laboratory environment, Expert and knowledgeable in cGMPs and other regulations in order to assure laboratory compliance, Leads and documents investigations according to established procedures and recommends corrective actions. Start Time: 8:00 AM, A Bachelor's degree in Microbiology or a major in another laboratory science provided that at least 20 semester or 30 quarter credit hours in microbiology are included; AND three (3) or more years of experience in a microbiology laboratory, Demonstrated experience in/with the following, USP & water testing; bulk pharmaceutical chemicals and drug product; culture maintenance; collecting samples; media preparation and qualification, Data review and good documentation practices, Bachelor's degree in Chemistry or related science from an accredited college or university, Minimum of 1-3 years of related laboratory work experience in a pharmaceutical environment, or an equivalent combination of training and experience, Performs and becomes proficient in microbiological analysis for the detection of Pathogenic organisms and indicator organisms in food products and environmental samples. Present microbiology data at internal and external meetings as required, Independently lead microbiology support for projects by developing a strong partnership with project teams and implementing microbiology parameters for QbD, Ensure all work is conducted in accordance with Good Laboratory practices and Health & Safety Practices, Lead laboratory audits and investigations as necessary, including those related to OOS / OOT results, Utilize the scientific network of Consumer Health R&D to leverage and build technical knowledge. LiveCareer has 13101 Senior Microbiologist CVs in its database. LiveCareer’s CV Directory contains real CVs created by subscribers using LiveCareer’s CV Builder. ... - Became senior nyear president in high school based on good grades and participation in sports. Ensure compliant and timely reporting and investigation close-out, Support development and improvement of laboratory processes and systems. Maintain records and analyze qualification data to insure quality products, Drive continuous improvement of environmental controls by performing real time risk assessments in classified areas. Prepare and sterilize laboratory equipment to ensure its availability for use, dispose of biohazard materials appropriately, and perform monthly preventive maintenance. Familiar with cleaning and sanitization validation approaches. Evaluate alternatives, propose and recommend solutions to problems. 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. 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. LIMS, Electronic Lab notebooks, Empower, Trackwise etc, Third-level qualification (Minimum: Primary degree in a science discipline), A minimum of 2 years' experience within the Pharmaceutical Industry, Knowledgeable of FDA/EMEA regulatory requirements applicable to pharmaceuticals and aseptic products, To oversee/co-ordinate and execute where required use of all microbial services, review and develop procedures for all microbiology/sterility assurance activities, Manage the environmental monitoring and utility monitoring program, Manage applicable NC and CAPA to resolution and closure, To co-ordinate and complete biological/biocompatibility testing and evaluations for product ranges as required, To carry out internal auditing of all Environmental controlled areas, Lead ECA Re-certification activities including review and approval of associated documents, To participate in audit of the sterilization subcontractors, contract laboratories and clean room clothing suppliers, To implement the GMP training programme for environmental controlled areas and other appropriate staff, To implement the microbial assurance aspects of the Quality System, To participate in applicable Stryker Ireland projects as required, Clear understanding of Sterilization and Biological Evaluation regulations for medical devices, Clear understanding of cGMP for Environmental controlled rooms, Knowledge of both the FDA and ISO regulations for medical devices, Lead the microbiology lab to ensure consistent delivery to customers, Provide technical expertise for all aspects of testing and out of specification investigations, Draft and review documentation -SOPs, protocols, training modules, investigations, reports and Trackwise documents, Ability to perform key tasks such as: Environmental Monitoring, water sampling, bioburden, endotoxin, verifications, growth promotion and in-process testing, Preform testing and ensure that testing schedule is adhered to and the results reported in a timely manner - escalation of any issues/OOS, Conduct and document out-of-specification/out-of-trend result investigations, Coach and develop individuals within the team, Responsible for overall performance of the microbiology function in areas of technical delivery and inter-team and inter-department collaboration, Collaboration with QC Leads and Associates to ensure the overall running of the QC Laboratory, Ensure the team is compliant to GxP, safety and environmental standards, Lead and implement initiatives that add value to QC and site operations, Third Level Degree in Microbiology or equivalent scientific degree, Minimum BSc in Microbiology or similar/equivalent, Solid experience of environmental monitoring, clean utilities, microbial ID, plate reading, bioburden, endotoxin, verifications, growth promotion and in-process testing, Demonstrated experience of developing and leading projects, Sterile manufacturing and/or biotech experience is preferable, Pharmaceutical drug/process development experience preferable, Working as directed by the Area Supervisor, in accordance with Company safety policies, cGMP and cGLP, Receiving and logging samples into the Micro Laboratory, Performing Micro analysis of raw material, in-process, finished product and stability samples associated with development products according to specifications, Performing micro analysis of water and environmental samples, Monitoring Micro trends in a timely fashion, Isolation and identification of organisms grown from test samples, Liaising with external labs on any micro testing that requires off site testing, Analysing validation samples according to validation protocols and investigational samples as directed, Recording results in a timely and accurate fashion, Ensuring the Right First Time KPI with respect to Analyst's documentation are achieved, Reviewing co-workers/analyst documentation (i.e. 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. If you're a senior citizen job seeker, your biggest challenge may lie in adapting your resume to depict you as qualified for the modern workplace. Takes on additional business related tasks as delegated by the Supervisor or Manager. Microbiological identification and characterization, Experience with conducting investigation, developing corrective and preventative (CAPA), and product impact assessment, Computer skills: Word, Excel, Project, Visio, LIMS, Leading the microbial characterization of microbial seed treatment formulations and the evaluation of their interaction with the seed, Working collaboratively across Monsanto to arrange and conduct testing supporting current commercial products, as well as the development and advancement of new formulation candidates. Documents appropriate and pertinent information on patient care record   •  Performs phlebotomy, specimen collection/processing and "... •  Proven organizational skills. Good written and verbal business communication skills. Performing sampling for validations and re-qualifications as required, Involved in NC and CAPA generation and resolution within the Microbiology group and across related business units, Performs sterilisation validations and re-qualifications in line with relevant BS EN ISO standards, To support the microbial assurance aspects of the Quality System, To carry out regular microbial monitoring of all clean room facilities and water systems, to analyze the results and recommend corrective action where appropriate, To co-ordinate use of all microbial services, To support the review and development of procedures for all microbial assurance activities, To carry out regular internal auditing of all clean room facilities and other areas, To implement the GMP training program for clean room and other appropriate staff, To be a member of New Product Development teams and undertake cleaning, microbial, sterilization validation as required, To support the release of sterile products, To support the Quality team in the preparation for and performance of all third party inspections and audits as appropriate, To create change controls identifying Microbial impact and necessary actions in line with WW and local procedures, To adhere to the Company's procedures as detailed in the SOP manual, Maintain a detailed knowledge of AAMI/ISO standards relevant to Sterilization and Environmental monitoring, To support specific projects as allocated by the International Sterility Assurance Manager, All employees are responsible for minimizing both the Environmental and Health & Safety effects of the work that they perform, Degree level qualification in Microbiology or equivalent, Minimum 3 years post qualification experience as a Microbiologist in a medical device, pharmaceutical, or similar regulated industry, Familiarity with microbiological aspects of GMP regarding sterile medical devices, Experience of conducting GMP audits, internal and relevant external audits, Actively supports Process microbiological investigations, Maintain, re-evaluate and communicate key critical inputs to site, Perform Risk Assessments for projects and business innovation initiatives from a microbiological perspective, Drives strategy improvements related to the reduction of contamination risks and the improvement of microbiological hygiene, Defines specific aseptic techniques to be performed for crucial process steps and provides meaningful input to processing operations, Collaborates with Process Microbiologists across the network and the Microbiological Review Comittee, Access global microbiology support resources as required, Reviewing and approving of relevant QC TM's, SOP's and WI's, Trouble shooting and support of manufacturing microbiological issues, Anticipating and planning for future requirements in both Manufacturing and the QC area, Ensuring activities are carried out in compliance with cGMP and company quality standards, Maintains records of investigation in accordance with cGMP, Participate in relevant internal and external QC related audits, Deputises for the QC Manager or Team Leader as appropriate, Support effective design and deployment of QC micro analyst training program, Support technical troubleshooting of QC micro process related testing methodologies and techniques, BSc in a scientific/technical discipline required, A minimum of 5 years' experience within the biological and/or pharmaceutical industry, Possesses detailed knowledge of routine and non-routine testing and sampling methods, techniques and related equipment, Conduct training as part of the team responsible for delivery of the Microbiology Certification program and or/ Co-ordinate / conduct program for the LATAM region, Provide appropriate consultations for microbiological inquiries and concerns. Includes aseptic technique, room equipment preparation, sanitation and disinfection, use of laminar flow, manifolds, autoclaves, incubators, plate counters etc, Understanding of environmental monitoring techniques such as air sampling, swab tests, Fundamental understanding of microbiological principles, Understanding of processing techniques and conditions for sensitive beverages eg thermal, pasteurized, preservation, Effective consultation and communication skills at all levels of the organization, Ability to train /consult with others on microbiological principles and techniques, Get the certification of Thermal Processing, At least 5 year’s experience in cosmetic microbiology laboratory, Must be well versed in observing, monitoring and identifying microorganisms, Maintaining of bacterial and fungal cultures, Experience in plate counting and sterile techniques, Knowledge of preservative challenge test procedures, Analyzing/interpreting of data and writing reports, Working knowledge of Microsoft Word, Excel and Power Point, Using knowledge of microbiology and engineering to invent, design & develop new products incorporating 3M technologies, Defining product specifications and build robust product designs that meet customer performance and usability requirements, Defining verification & regulatory submission test plans, develop test methods, perform required testing, summarize and document test results, Overseeing technical activities in global product registrations and with external partners, Acting as technical lead on cross-functional product development projects, Interacting with consumers to understand their needs and desires for our product platforms, Training lab members on new and/or advanced techniques, Contributing to intellectual property as applicable, Master’s degree or higher in a science or engineering discipline from an accredited university, Minimum of five (5) years combined research and development and/or laboratory environment experience, Ph.D. in Microbiology, Biotechnology, Biomedical Engineering or a related discipline from an accredited university, Microbiology experience with pathogenic microorganisms, Organizational and project management skills– New Product Introduction (NPI), technical team leadership experience desired, Experience in new product design & development with demonstrated success effectively contributing to cross-functional teams and commercializing new products, Analytical abilities with demonstrated use of design of experiments and other statistical methods or tools, Minimum one (1) year medical device and/or pharmaceutical industry experience, Strong communications skills (written , verbal and presentation) with a focus on technical writing, Passionate, self-motivated, inquisitive, imaginative, and detail-oriented, Take reasonable care to protect his or her own and the safety of their colleagues who may be affected by their actions, Comply with EHS rules and procedures at all times, Understand the potential EHS impact of their activities, Attend and participate in EHS training as required, Report all incidents, accidents, and near miss events, Report unsafe plant, equipment, acts, procedures or issues, Make suggestions to improve health and safety in the workplace, Actively participate in work area EHS teams, Not turn a ‘blind eye’ to unsafe acts or situations, Ability to operate as part of a team is critical, To work as a strategic partner with all other departments, A minimum of 5 years’ experience within the biological and/or pharmaceutical industry, Possesses deatiled knowledge of routine and non-routine testing and sampling methods, techniques and related equipment, Possess a detailed knowledge of the shop floor manufacturing process, Possess a comprehensive knowledge of trending using statistical analysis, Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals, Business Excellence and Problem Solving skills Qualifications e.g, In terms of micro laboratory services ensure all laboratory reagents, chemicals, test methods, equipment are acceptable for testing purposes, Should be able to execute cleanliness drives and develop GMP standards, Manage sourcing of Lab equipment, chemicals and micro consumables and ensure GLP standards, Provide technical expertise on assigned areas related to microbiological, sanitation and food safety standard, Sample and analyze ingredients, work in progress and finished product for microbiological compliance to specification, Educates and trains colleagues in Food Safety to ensure compliance to Company Standards, Carry out Microbiological reporting on FG on monthly basis, Regarding GMP the person should Ensure FQPs and GMPs are in place covering Equipment & Building hygiene, Sanitation & Cleaning, housekeeping, Infestation & Pest management and Prevention of potential contaminants, Conduct regular audits to assure compliance to the QPs/QCMS and Sanitation. ’ t forget to read our 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