Job Title

The Microbiologist reports directly to the Quality Aseptic Manager. The role is responsible for overseeing third party sterility testing and environmental monitoring testing for the Company's 503B sterile cGMP manufacturing facility. Responsible for environmental monitoring program including sampling, scheduling, and trending activities. This role offers a dynamic opportunity to drive environmental monitoring and Quality processes in a collaborative team setting.Why Join Leiters Health? Are you passionate about making a real impact in the pharmaceutical industry? Do you thrive in a collaborative, innovative environment where your skills and ideas are valued? Look no further - Leiters Health is seeking talented individuals like you to join our dynamic team! At Leiters Health, we're not just another pharmaceutical company - we're pioneers in the field, dedicated to delivering high-quality compounded sterile products and outsourced solutions to healthcare providers nationwide. Our commitment to excellence and patient safety is at the core of everything we do. Innovative Culture: Be part of a forward-thinking company that encourages creativity, welcomes fresh ideas, and fosters an environment of continuous improvement.Meaningful Work: Contribute to a purpose-driven organization dedicated to providing critical medications and healthcare solutions that positivelyimpactpatients' lives.Professional Development: Access ongoing training, mentorship, and growth opportunities to expand your skills and advance your career within a rapidly growing industry.Cutting-EdgeTechnology: Work withstate-of-the-artfacilities and advanced technologies, staying ahead of the curve in pharmaceutical manufacturing.Collaborative Environment: Join a team of passionate individuals who are dedicated to teamwork, support, and mutual success, fostering a culture of inclusivity and collaboration.Who We're Looking For: We're seeking enthusiastic individuals who are driven, adaptable, and passionate about contributing to a mission-driven organization. Whether you're an experienced professional or just starting your career, Leiters Health provides an environment where your skills and talents will be recognized and appreciated. Sound like you? Apply today! Essential Functions:Oversee environmental monitoring (EM) program, assist as neededOversee EM process qualifications of new cleanroom areasOversee microorganism identification programUnderstand Leiter's monitoring programs and methods and conduct troubleshooting analysisOversee or perform growth promotion testing of media as per compendial methodsAssist in internal laboratory, as neededWork with internal and external resources to maintain lab in an optimal stateMonitor, trend, and report environmental monitoring data, keeping management informed on trends and implementing corrective actions as necessaryComplete routine record review of test data and related documents for in-process testing, drug substance and drug product release. Assist in generation of CoAs for product release as neededDevelop, revise, and review SOPs, job aids, forms, qualification/validation protocols, and reportsAssist in investigations regarding out of specifications (OOS) results and deviations through root cause analysisManage CAPAs and change controls to ensure timely resolution of issues and continuous improvement of Quality processesMonitor the GMP systems currently in place to ensure compliance with documented policiesReview and assess proposed changes to procedures, systems, methods, and regulatory submissions as appropriateGather and analyze metrics to drive continuous improvement in areas of responsibilityCollaborate with Training, Quality Aseptic, and other departments for implementing process improvements and job aidsCollaborate with Quality Control department to ensure timely completion of environmental monitoring testing and sterility testing as needed for batch releasePerform other duties as requiredExperience and Necessary Skills: Bachelor's degree in Microbiology, Biology, or related technological field of science required1-3 years of microbiology lab experience and/or environmental monitoring in the biotech and/or pharmaceutical industry working with sterile injectables requiredProficient in microbiological techniques, including air monitoring, water testing, surface monitoring, and microbial identificationExperience with aseptic technique and cleanroom operationExperience with the sterile gowning proceduresKnowledge of regulatory requirements for aseptic operations and manufacturing of sterile drug productsWorking knowledge of quality systems and regulatory requirements (21 CFR Part 11/210/211)Strong knowledge of GMP, SOPs, and quality control processesExperience managing and resolving OOS results and investigationsWorking knowledge of aseptic manufacturing and EM processesProficient in MS Word, Excel, Power Point and other applicationsAbility to communicate and work independently with scientific/technical personnelStrong critical thinking, troubleshooting, and problem-solving abilities Self-motivated and willing to accept temporary responsibilities outside of initial job descriptionExcellent interpersonal, verbal, and written communication skills in a collaborative work environmentComfortable in a fast-paced, small company environment with minimal oversight and able to adjust workload based upon changing prioritiesPhysical Requirements:Ability to stand or sit for extended periods of time.Ability to lift, push and pull up to 50 pounds periodically. Benefits: Smart healthcare coverage options that rewards wellness (and puts money back in your pocket!)Flexible Spending & Health Savings Accounts (FSA & HSA) availableDental & Vision insurance Employer Paid Life Insurance & Employee Assistance ProgramShort Term & Long-Term Disability InsuranceUp to 4% 401K Matching (100% vested on day one!)Generous Paid Time Off Options - vacation,sick, paid leave and holidays!$5,250 Annual Tuition Reimbursement after 6 months$1,000 Referral Bonus Program with no limitEligible for annual bonus program Timeline: We will be accepting applications on an ongoing basis until position is filled. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. *Please note that we do not work with third-party recruiters or agencies for this position. If you are a qualified candidate and wish to apply for this job, please do so directly through our official application process. We appreciate your understanding and cooperation in this matter.