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  • Quality Control Microbiologist

    STAQ Pharma Inc. 3.7company rating

    Medical microbiologist job in Columbus, OH

    Job Description The Microbiologist I performs routine and non-routine microbiological testing, environmental monitoring, and data review to ensure aseptic control of classified areas. This role supports ongoing contamination control efforts, batch disposition, and investigation activities. Responsibilities: • Conduct viable, non-viable, and surface environmental monitoring across classified areas (ISO 5- 8). • Enumerate and verify environmental samples, media fills, and gowning plates. • Perform morphological assessments and basic microbial identifications. • Document test results and deviations accurately in laboratory records. • Maintain calibration and preventive maintenance of environmental monitoring equipment. • Participate in routine cleaning, disinfectant rotation, and lab upkeep. • Support trending and data review of EM and utility monitoring programs. • Conduct investigations and support maintenance of the Environmental monitoring program. • Write out-of-specification investigations and assist with CAPA execution. • Follow all gowning, aseptic, and cGMP requirements for Grade A/B/C/D spaces. • Solve process, procedural, equipment issues via experimentation or revision of procedures. • Develop necessary submission documentation, for the FDA and/or other regulatory bodies. • Perform other duties as assigned by management. Required Skills/Abilities: (examples) • Excellent verbal and written communication skills. • Excellent interpersonal and customer service skills. • Preferred previous pharmaceutical experience, 503b compounding facility experience desired.. • Familiarity with 21 CFR Part 11/210/211 • Working knowledge of aseptic technique and microbiological testing. • Understanding of cleanroom behavior and contamination control principles. • Strong organization, documentation, and time management skills. • Ability to interpret environmental monitoring data. • Familiarity with USP , , , , and Annex 1 preferred. Education and Experience: • B.S. or B.A. in Microbiology or a closely related field / or equivalent experience • Experience with cGMP aseptic manufacturing environment. • Minimum one (1) to three (3) years' experience in a sterile, cGMP, and quality control environment. Physical Requirements: • Prolonged periods of sitting at a desk and working on a computer. • Must be able to lift up to 15 pounds at times.
    $32k-52k yearly est. 21d ago
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  • Senior Medical Laboratory Scientist

    Sentara Healthcare 4.9company rating

    Remote medical microbiologist job

    City/State South Boston, VA Work Shift First (Days) Sentara Halifax is hiring an experienced Senior Medical Laboratory Scientitst to work full time days Sign on bonus up to $20,000 for qualified candidates! Job Description: Performs laboratory testing and interprets test results using scientific knowledge and principles of test procedures and disease processes; recommends contingency testing. Directly responsible for developing, maintaining, and managing daily technical operations, including staff training and education, implementation of instrumentation, and accreditation readiness. Responsible for the immediate supervision, training, and competency assessment of laboratory staff and students in a 24/7 environment. Ensures accurate orders for proficiency surveys and accurate submission of survey data. Collections PI data, conducts analysis and documents progress. Maintains current policies and procedures in the department and ensures completion of electronic documents according to established assignments and timelines. Demonstrates fiscal responsibility. Education Bachelor's Degree in Biology/Chemical Science or Medical Technology Certification: ASCP Certification required Join a team that has a Mission to improve health every day, join the Sentara Team! Our Caring Workplace Environment Our Caring Tradition of serving for 100+ years providing personalized care tailored to the needs of each patient Free and convenient parking Collaboration and shared governance Caring For Your Family and Your Career Tuition Assistance - $5,250 year Student Debt Pay Down - $10,000 Reimbursement for certifications and free access to complete CEUs and professional development Emergency Backup Care - 10 days Paid Parental Leave - up to 4 weeks Family Caregiver Leave - 2 weeks Adoption, Fertility and Surrogacy Reimbursement up to $10,000 Benefits: Caring For Your Family and Your Career• Medical, Dental, Vision plans• Adoption, Fertility and Surrogacy Reimbursement up to $10,000• Paid Time Off and Sick Leave• Paid Parental & Family Caregiver Leave • Emergency Backup Care• Long-Term, Short-Term Disability, and Critical Illness plans• Life Insurance• 401k/403B with Employer Match• Tuition Assistance - $5,250/year and discounted educational opportunities through Guild Education• Student Debt Pay Down - $10,000• Reimbursement for certifications and free access to complete CEUs and professional development• Pet Insurance • Legal Resources Plan• Colleagues may have the opportunity to earn an annual discretionary bonus if established system and employee eligibility criteria is met Sentara Halifax Regional Hospital is fueled by the expertise of a well-established medical staff representing more than two-dozen specialties, while remaining focused on excellent care. Services at this hospital include cardiovascular services, emergency services, family birthing center, hospitalist program, imaging/radiology services, laboratory services, nephrology services, orthopedic services, rehabilitation services and surgical services. We improve health every day, come be a part of the community. Sentara Health is an equal opportunity employer and prides itself on the diversity and inclusiveness of its close to an almost 30,000-member workforce. Diversity, inclusion, and belonging is a guiding principle of the organization to ensure its workforce reflects the communities it serves. In support of our mission “to improve health every day,” this is a tobacco-free environment. For positions that are available as remote work, Sentara Health employs associates in the following states: Alabama, Delaware, Florida, Georgia, Idaho, Indiana, Kansas, Louisiana, Maine, Maryland, Minnesota, Nebraska, Nevada, New Hampshire, North Carolina, North Dakota, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin, and Wyoming.
    $10k monthly Auto-Apply 41d ago
  • Site Microbiologist

    Kutol Products Company

    Medical microbiologist job in Sharonville, OH

    Job Description Allow me to introduce you to Kutol Products Company, we are a thriving hand soap and hand sanitizer manufacturer operating out of our Silver LEED Certified facility in Sharonville, Ohio. We process and package both cosmetic and drug formulas that work with our proprietary dispensing systems across the country and beyond. We are currently seeking a Site Microbiologist to join us in our purpose of providing “Clean Hands for a Healthy World.” At Kutol the Site Microbiologist is responsible for developing and implementing microbiological testing programs, assessments, and awareness initiatives to ensure site-wide compliance and contamination control. This role manages microbiological lab operations, personnel qualification, and adherence to GMPs and regulatory standards. The Site Microbiologist will report to the Director of Quality. Microbiological lab operations, lab standards and procedures Qualification of micro lab personnel in methods and procedures Compliance to required microbiological operating standards and procedures Microbiology Daily Management System Microbiological investigations Compliance with relevant GMPs and other regulations applicable to Kutol and its customers The responsibilities of this position include: Microbiology Daily Management System Conduct regular microbiological assessments across manufacturing processes, environments, raw material handling, water systems, and hygiene practices. Ensure all samples are tested per approved methods with full traceability. Establish and manage the site's microbiological testing laboratory in compliance with validated methods and procedures. Hire, supervise and evaluate Micro Lab Technicians. Collaborate with the Plant Hygienist to develop and maintain a Micro Daily Management System, including test types, frequency, data trending, and action/alert levels. Review microbiological data with Operations and recommend corrective actions. Prepare and present monthly reports to QA and site leadership. Microbiological Control Implement and enforce lab controls, standards, and procedures. Ensure only approved methods are used for testing incoming materials. Conduct method suitability/validation for new products or materials before production. Train and qualify lab technicians in all required methods and document training records. Promote microbiological risk awareness across the site. Integrate microbiological training into the site's overall training plan. Partner with the Plant Hygienist to implement sanitary practices in manufacturing. Ensure personnel are trained in aseptic sampling techniques. Evaluate proposed changes to products, processes, or maintenance to preserve microbial integrity. Sanitary Design Participate in change control processes and update the Micro Daily Management System accordingly. Train Maintenance, Engineering, and other teams on microbiological principles. Identify and recommend improvements to equipment design to reduce contamination risks. Cleaning and Sanitization Support development of robust sanitization procedures for microbiologically susceptible systems. Establish sanitizer usage strategies, including rotation protocols. Define microbiological limits and test methods for cleaning and sanitization validation. Review sanitization logs regularly for procedural compliance. Contamination Response Lead and document all microbiological contamination and out-of-specification investigations. Define sampling plans to assess contamination scope. Advise leadership on severity and response strategies for microbial incidents. Ensure timely identification of contaminant organisms using appropriate methods. Prepare risk assessments and recommend remedial actions. Requirements Education and Experience Bachelor's degree in Microbiology or Engineering with microbiological specialization (e.g., Biotechnology, Food/Dairy Engineering). Strong technical understanding of microbiology in industrial processes, standards, and product testing. Knowledge, Skills and Ability Strong investigative and documentation skills. Proficiency in microbiological testing methods (e.g., USP , , , Gram stain, MALDI-TOF, 16S sequencing). Knowledge of lab safety standards and microbiological controls. Understanding of statistical sampling for data tracking and trending. Authority to halt production when contamination risks are identified. Effective leadership and change management capabilities. Familiarity with regulatory requirements (e.g., CFR 210/211 for OTC drugs). Strong communication and collaboration skills to coach and influence site leadership. Physical/Mental Requirements: Ability to walk plant floor, negotiate step ladders, and work in plant conditions in order to audit/observe operations. Combination sit 60% Stand/Walk 40% of the time Exposure to chemicals, fragrances, perfumes and maintenance products Hand-eye coordination and mental/visual stamina for sustained use of computers and data analysis Benefits As a company, we offer stability in a thriving industry and an environment that emphasizes our core values of respect, honesty and fairness. Standard hours are 8am - 5pm, but you'll have the freedom to craft your schedule to interface with our 3 shift operation. Salary for qualified candidates will be $90K annually. A review of your performance will be made after three months in the position, and performance and compensation reviewed on your one-year anniversary. Kutol's benefit package includes medical, dental, vision, 401K and more including profit-sharing when we succeed as a team. Our TeamMates enjoy working at Kutol because of our shared-fate environment and stability as an established 100+ year old local company. Please note, we are a drug free & tobacco free workplace. Apply now and see why Kutol is a fantastic place to work.
    $90k yearly 11d ago
  • Senior Medical Laboratory Scientist

    Sentara Healthcare 4.9company rating

    Remote medical microbiologist job

    City/State Norfolk, VA Work Shift First (Days) Additional Job Description Sentara Norfolk General Hospital in Norfolk, VA is hiring an experienced Sr. Laboratory Scientist to work full days (645a-315p) in the Core Lab. Generous Sign on Bonus up to $20,000 for qualified candidates! As a Sr. Laboratory Scientist, duties are to perform laboratory testing and interpret test results using scientific knowledge and principles of test procedures and disease processes; recommends contingency testing. Directly responsible for developing, maintaining, and managing daily technical operations, including staff training and education, implementation of instrumentation, and accreditation readiness. Education Bachelor's in medical technology or Biology/Chemical Science (required) Certification/Licensure ASCP, AMT, or AAB certification (required) Experience 3 year of laboratory experience (required) Click here to learn more about Sentara Norfolk General Hospital! keyword: MLS, medical laboratory scientist, MT, medical laboratory technologist, CLS, Clinical lab Specialist, Talroo-Allied Health , Laboratory Services . Benefits: Caring For Your Family and Your Career • Medical, Dental, Vision plans• Adoption, Fertility and Surrogacy Reimbursement up to $10,000• Paid Time Off and Sick Leave• Paid Parental & Family Caregiver Leave • Emergency Backup Care• Long-Term, Short-Term Disability, and Critical Illness plans• Life Insurance• 401k/403B with Employer Match• Tuition Assistance - $5,250/year and discounted educational opportunities through Guild Education• Student Debt Pay Down - $10,000• Reimbursement for certifications and free access to complete CEUs and professional development• Pet Insurance • Legal Resources Plan• Colleagues may have the opportunity to earn an annual discretionary bonus if established system and employee eligibility criteria is met Here at Sentara, we are committed to consistently enhancing our training, advancement tracks, work-life benefits, and more. Our goal is to make you feel more excited to be here every day! Sentara Norfolk General Hospital, located in Norfolk, VA, is a 525-bed tertiary care facility that is home to the only Level I Adult Trauma Center and burn trauma unit in Hampton Roads, and also serves as the primary teaching hospital for Eastern Virginia Medical School. In addition to the high-quality heart program at Sentara Heart Hospital, our facility is home to Nightingale Regional Air Ambulance and several other dedicated facilities and specialized services. As a recognized accredited Comprehensive Stroke Center, and Magnet hospital for nursing excellence, our hospital specializes in heart and vascular, neurosciences, neurosurgery, urology, oncology, spine care, advanced imaging, behavioral health, maternity, and women's health, including a state-of-the-art neonatal intensive care unit. Sentara Health is an equal opportunity employer and prides itself on the diversity and inclusiveness of its close to an almost 30,000-member workforce. Diversity, inclusion, and belonging is a guiding principle of the organization to ensure its workforce reflects the communities it serves. In support of our mission “to improve health every day,” this is a tobacco-free environment. For positions that are available as remote work, Sentara Health employs associates in the following states: Alabama, Delaware, Florida, Georgia, Idaho, Indiana, Kansas, Louisiana, Maine, Maryland, Minnesota, Nebraska, Nevada, New Hampshire, North Carolina, North Dakota, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin, and Wyoming.
    $42k-60k yearly est. Auto-Apply 34d ago
  • QC Microbiologist

    Kelly Services 4.6company rating

    Medical microbiologist job in Olde West Chester, OH

    **Analyst I - QC Microbiology (Contract)** **Employment Type:** Contract (6-12 months with possibility of extension or conversion) **Pay Rate:** $30-$32, depending on experience The Analyst I, QC Microbiology contract role supports a Quality Control Microbiology department by performing quality-related activities for pharmaceutical products. Responsibilities include documenting and executing microbiological testing on a variety of sample types such as raw materials, in-process and finished products, stability samples, water, gas, and environmental samples, in compliance with cGMP requirements. **Key Responsibilities** + Read, interpret, and follow SOPs (Standard Operating Procedures) and technical documentation. + Author, review, and revise SOPs and work instructions supporting cGMP manufacturing of commercial products. + Complete required training and assist with training other personnel as needed. + Perform troubleshooting activities related to QC microbiology processes and data. + Gather, organize, and communicate operational and quality-related information to cross-functional teams. + Participate in and facilitate team meetings to discuss progress, initiatives, and issues. + Actively support investigations related to QC processes, including sampling, deviations, and testing impacts. + Assist with coordinating activities among internal support groups. + Analyze data trends to identify root causes, propose corrective actions, and recommend process improvements. + Author and maintain quality records including Deviations, CAPAs, and Change Controls. + Identify and implement temporary and permanent solutions to quality or process issues. + Escalate issues that fall outside of established SOPs to appropriate leadership. + Collect, track, and report metrics related to QC microbiology operations. + Monitor equipment and systems for performance and potential issues. + Perform gowning and wear sterile garments and PPE as required. + Serve as a subject matter expert (SME) within assigned systems or processes. + Perform logbook reviews to ensure data integrity and compliance. + Lead or participate in continuous improvement and process optimization initiatives. + Utilize systems such as MAXIMO and/or other CMMS tools to support equipment and maintenance coordination. + Support regulatory inspections and audits, including interactions with regulatory agencies when required. + Coordinate qualification and validation-related activities. + Perform routine sampling of facility utilities (e.g., water, gases). + Recommend compliance solutions and risk mitigations to management. + Participate in interdepartmental meetings to support cross-functional coordination. **Qualifications** + Bachelor's degree in Biology, Microbiology, or a related scientific discipline. + Minimum of 2 years of laboratory experience in the pharmaceutical or biotechnology industry. + Prior experience supporting microbiological testing in a sterile manufacturing environment. As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here (********************************************************************* for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community. Why Kelly Science & Clinical? Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed. About Kelly Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life-just ask the 300,000 people we employ each year. Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S. Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.
    $30-32 hourly 7d ago
  • Microbiologist

    Q Labs 3.6company rating

    Medical microbiologist job in Cincinnati, OH

    Q Labs is looking for a Microbiologist 1 to conduct general microbiological analyses, including rapid screening tests, in a timely and scientifically sound manner with primary focus on basic microbiological analyses such as aseptic sample preparation, sample enrichments, plating, isolation streaks, microscopy, and related instrument use, etc. on incoming food, pharmaceutical, and/or other types of samples. This role will be Tuesday through Friday, 11am to 8pm, and Saturday, 9am to 6pm. Primary Responsibilities: Conduct the assigned study/analysis in accordance with SOP's/prescribed methodology. Maintain the necessary quality control records to substantiate the proper conductance of the test procedures; maintain proper records of all test procedures and generated data following laboratory Good Documentation Practices. Actively participate in the protocol review of new studies, the development of study schedules, and the acquisition of necessary laboratory materials. Begin management of small-scale projects, as directed. Initiate training on project management, as directed. Monitor equipment in the section and report any malfunctions to the Supervisor. Successfully participate in applicable proficiency testing programs. Keep laboratories neat and organized. Work weekend/holiday hours upon request. Other duties as assigned. Skills and Abilities: Ability to use and maintain necessary equipment in the laboratory; can lift up to 50 pounds. Mathematical and microbiological knowledge to perform calculations. Knowledge of appropriate microbiological techniques; ability to perform tasks/assignments in an aseptic manner, including SOP comprehension. Can follow instructions and understand methodology employed in the area. Ability to keep accurate, legible, and complete records following good documentation practices; good written communication and documentation skills. Can interact positively and professionally with others within the Microbiology lab(s) and throughout the entire company. Can recognize errors and omissions and bring them to the attention of the Supervisor in a timely manner. Ability to plan for reagent, media, glassware, equipment, & supply requirements and complete appropriate requisitions. Demonstrated organization skills; can plan daily work schedule to utilize time efficiently. Ability to recognize any malfunctions in equipment and report to the attention of a the Supervisor in a timely manner. Can recognize unsafe laboratory situations and bring to the attention of the Supervisor or designated individual. Education and Experience: Completion of four years of college, resulting in graduation or its equivalent, with major work in Microbiology, Biology, or a closely related field. Completion of 2 years of college, resulting in graduation or its equivalent, with major work in Laboratory Science or a related field + one year of laboratory experience. Job Types: Full-time, Part-time Benefits: 401(k) 401(k) matching Dental insurance Employee assistance program Flexible spending account Health insurance Health savings account Life insurance Paid time off Parental leave Professional development assistance Vision insurance Ability to Commute: Cincinnati, OH 45204 (Required) Ability to Relocate: Cincinnati, OH 45204: Relocate before starting work (Required) Work Location: In person
    $34k-49k yearly est. 3d ago
  • Senior Medical laboratory scientist

    Sentara Healthcare 4.9company rating

    Remote medical microbiologist job

    City/State Norfolk, VA Work Shift First (Days) Sentara Norfolk General Hospital in Norfolk, VA is hiring an experienced Sr. Laboratory Scientist to work full days in Microbiology. (0500-1530) Generous Sign on Bonus up to $20,000 for qualified candidates! As a Sr. Laboratory Scientist, duties are to perform laboratory testing and interpret test results using scientific knowledge and principles of test procedures and disease processes; recommends contingency testing. Directly responsible for developing, maintaining, and managing daily technical operations, including staff training and education, implementation of instrumentation, and accreditation readiness. Education * Bachelor's in medical technology or Biology/Chemical Science Certification/Licensure * ASCP or AMT certification Experience * 3 year of experience * Microbiology experience * keyword: MLS, medical laboratory scientist, MT, medical laboratory technologist, CLS, Clinical lab Specialist, Talroo-Allied Health , Laboratory Services, #Indeed, #LI-KB1 . Benefits: Caring For Your Family and Your Career * Medical, Dental, Vision plans * Adoption, Fertility and Surrogacy Reimbursement up to $10,000 * Paid Time Off and Sick Leave * Paid Parental & Family Caregiver Leave * Emergency Backup Care * Long-Term, Short-Term Disability, and Critical Illness plans * Life Insurance * 401k/403B with Employer Match * Tuition Assistance - $5,250/year and discounted educational opportunities through Guild Education * Student Debt Pay Down - $10,000 * Reimbursement for certifications and free access to complete CEUs and professional development * Pet Insurance * Legal Resources Plan * Colleagues may have the opportunity to earn an annual discretionary bonus if established system and employee eligibility criteria is met Here at Sentara, we are committed to consistently enhancing our training, advancement tracks, work-life benefits, and more. Our goal is to make you feel more excited to be here every day! Sentara Norfolk General Hospital, located in Norfolk, VA, is a 525-bed tertiary care facility that is home to the only Level I Adult Trauma Center and burn trauma unit in Hampton Roads, and also serves as the primary teaching hospital for Eastern Virginia Medical School. In addition to the high-quality heart program at Sentara Heart Hospital, our facility is home to Nightingale Regional Air Ambulance and several other dedicated facilities and specialized services. As a recognized accredited Comprehensive Stroke Center, and Magnet hospital for nursing excellence, our hospital specializes in heart and vascular, neurosciences, neurosurgery, urology, oncology, spine care, advanced imaging, behavioral health, maternity, and women's health, including a state-of-the-art neonatal intensive care unit. Sentara Health is an equal opportunity employer and prides itself on the diversity and inclusiveness of its close to an almost 30,000-member workforce. Diversity, inclusion, and belonging is a guiding principle of the organization to ensure its workforce reflects the communities it serves. In support of our mission "to improve health every day," this is a tobacco-free environment. For positions that are available as remote work, Sentara Health employs associates in the following states: Alabama, Delaware, Florida, Georgia, Idaho, Indiana, Kansas, Louisiana, Maine, Maryland, Minnesota, Nebraska, Nevada, New Hampshire, North Carolina, North Dakota, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin, and Wyoming.
    $42k-60k yearly est. Auto-Apply 60d+ ago
  • Microbiologist

    Oakwood Labs 4.2company rating

    Medical microbiologist job in Solon, OH

    Oakwood Laboratories Quality Control Microbiology Department is searching for a Microbiologist. Essential Job Functions: Environmental monitoring of ISO classified rooms and personnel monitoring (gown and glove sites). Required to obtain gown certification to access the aseptic core. Microbiological sampling and testing compressed gas and water systems. Test raw materials for bioburden (membrane filtration method and/or plate count method). Analyze drug product samples : IP/PF bulk solutions for bioburden by membrane filtration, FP bacterial endotoxin by kinetic chromogenic method. Test of components vials and/or stoppers (bioburden and/or endotoxin) We are seeking individuals with: Bachelor of Science (B.S.) degree in Microbiology or Biological Science and/or at least Bachelor of Arts (B. A.) degree in Life Science with a minimum of two years of experience in a GMP laboratory environment or equivalent. Experience with sterile aseptic techniques for laboratory and clean room practices. Preferred previous gowning experience for aseptic core. Microbiology testing knowledge (membrane filtration and plate count methods). Prior experience using Microsoft Word and Excel. GMP and/or GLP training is preferred. Remain current with regulatory requirements and emerging industry trends.
    $39k-53k yearly est. 42d ago
  • Site Microbiologist

    Kutol Products Company

    Medical microbiologist job in Sharonville, OH

    Allow me to introduce you to Kutol Products Company, we are a thriving hand soap and hand sanitizer manufacturer operating out of our Silver LEED Certified facility in Sharonville, Ohio. We process and package both cosmetic and drug formulas that work with our proprietary dispensing systems across the country and beyond. We are currently seeking a Site Microbiologist to join us in our purpose of providing “Clean Hands for a Healthy World.” At Kutol the Site Microbiologist is responsible for developing and implementing microbiological testing programs, assessments, and awareness initiatives to ensure site-wide compliance and contamination control. This role manages microbiological lab operations, personnel qualification, and adherence to GMPs and regulatory standards. The Site Microbiologist will report to the Director of Quality. Microbiological lab operations, lab standards and procedures Qualification of micro lab personnel in methods and procedures Compliance to required microbiological operating standards and procedures Microbiology Daily Management System Microbiological investigations Compliance with relevant GMPs and other regulations applicable to Kutol and its customers The responsibilities of this position include: Microbiology Daily Management System Conduct regular microbiological assessments across manufacturing processes, environments, raw material handling, water systems, and hygiene practices. Ensure all samples are tested per approved methods with full traceability. Establish and manage the site's microbiological testing laboratory in compliance with validated methods and procedures. Hire, supervise and evaluate Micro Lab Technicians. Collaborate with the Plant Hygienist to develop and maintain a Micro Daily Management System, including test types, frequency, data trending, and action/alert levels. Review microbiological data with Operations and recommend corrective actions. Prepare and present monthly reports to QA and site leadership. Microbiological Control Implement and enforce lab controls, standards, and procedures. Ensure only approved methods are used for testing incoming materials. Conduct method suitability/validation for new products or materials before production. Train and qualify lab technicians in all required methods and document training records. Promote microbiological risk awareness across the site. Integrate microbiological training into the site's overall training plan. Partner with the Plant Hygienist to implement sanitary practices in manufacturing. Ensure personnel are trained in aseptic sampling techniques. Evaluate proposed changes to products, processes, or maintenance to preserve microbial integrity. Sanitary Design Participate in change control processes and update the Micro Daily Management System accordingly. Train Maintenance, Engineering, and other teams on microbiological principles. Identify and recommend improvements to equipment design to reduce contamination risks. Cleaning and Sanitization Support development of robust sanitization procedures for microbiologically susceptible systems. Establish sanitizer usage strategies, including rotation protocols. Define microbiological limits and test methods for cleaning and sanitization validation. Review sanitization logs regularly for procedural compliance. Contamination Response Lead and document all microbiological contamination and out-of-specification investigations. Define sampling plans to assess contamination scope. Advise leadership on severity and response strategies for microbial incidents. Ensure timely identification of contaminant organisms using appropriate methods. Prepare risk assessments and recommend remedial actions. Requirements Education and Experience Bachelor's degree in Microbiology or Engineering with microbiological specialization (e.g., Biotechnology, Food/Dairy Engineering). Strong technical understanding of microbiology in industrial processes, standards, and product testing. Knowledge, Skills and Ability Strong investigative and documentation skills. Proficiency in microbiological testing methods (e.g., USP , , , Gram stain, MALDI-TOF, 16S sequencing). Knowledge of lab safety standards and microbiological controls. Understanding of statistical sampling for data tracking and trending. Authority to halt production when contamination risks are identified. Effective leadership and change management capabilities. Familiarity with regulatory requirements (e.g., CFR 210/211 for OTC drugs). Strong communication and collaboration skills to coach and influence site leadership. Physical/Mental Requirements: Ability to walk plant floor, negotiate step ladders, and work in plant conditions in order to audit/observe operations. Combination sit 60% Stand/Walk 40% of the time Exposure to chemicals, fragrances, perfumes and maintenance products Hand-eye coordination and mental/visual stamina for sustained use of computers and data analysis Benefits As a company, we offer stability in a thriving industry and an environment that emphasizes our core values of respect, honesty and fairness. Standard hours are 8am - 5pm, but you'll have the freedom to craft your schedule to interface with our 3 shift operation. Salary for qualified candidates will be $90K annually. A review of your performance will be made after three months in the position, and performance and compensation reviewed on your one-year anniversary. Kutol's benefit package includes medical, dental, vision, 401K and more including profit-sharing when we succeed as a team. Our TeamMates enjoy working at Kutol because of our shared-fate environment and stability as an established 100+ year old local company. Please note, we are a drug free & tobacco free workplace. Apply now and see why Kutol is a fantastic place to work.
    $90k yearly Auto-Apply 60d+ ago

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