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Microbiologist - 1st Shift

MSCCN - Raleigh, NC

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Job Description

Description Microbiologist Summary of the position: Performs biological assays of clinical and/or commercial product raw materials, production in-process samples, finished product, environmental monitoring samples, process & cleaning validation samples and components as well as some specialized techniques. Assays are qualitative, quantitative, and investigational in nature and are performed in compliance with USP, FDA and other regulatory body requirements, Guerbetu2019s standard operating procedures, and approved license requirements. Results are compared with specifications and documented. Incumbent has mastered most fundamental technical and quality concepts. May provide guidance and training to more junior staff members. Essential Functions & Responsibilities: Perform various microbiological essays, including but not limited to: u2022 Microbial Bioburden of facility water system, in-process/finished products, filling components, raw materials, filling containers/components, and environmental monitoring samples. u2022 Endotoxin testing via Kinetic Turbidimetric Assay and Gel Clot methods for facility water system, in-process/finished products, filling containers/components, and raw materials. u2022 Container Closure Integrity Testing of finished product via Dye Ingress. u2022 Particulate Matter testing of finished product utilizing the HIAC Liquid Particle Counting System. u2022 14-Day Sterility Testing utilizing Walker Barrier System Isolator. Perform Environmental Monitoring (EM) processes, including but not limited to: u2022 Perform viable air sampling utilizing SAS 100 and SAS Super 180. u2022 Perform non-viable particulate sampling utilizing Met One. u2022 Perform viable surface sampling via plating and swabbing. u2022 Perform personnel monitoring as part of gowning qualification program. Perform Sampling of Facility Water System and Clean Steam, including but not limited to: u2022 Collection and testing of Microbial Bioburden samples. u2022 Collection and testing of Endotoxin samples. u2022 Collection and submission of Conductivity and Total Organic Carbon (TOC) samples to Chemistry Laboratory Perform entry and analysis of Environmental Monitoring and Laboratory Assay results, including but not limited to: u2022 Data entry within digital Laboratory Information Management System (LIMS). u2022 Trending of Out of Specification (OOS) sample results. u2022 Conduct routine trend analysis of microbiological data. u2022 Identifying trends or atypical results and escalating to leadership for further investigation. u2022 Conducting minor/major investigations as necessary. u2022 Conducting OOS investigations as necessary. u2022 Assisting with execution of Corrective and Preventive Action (CAPA) projects. General Laboratory tasks as assigned of as evident, including but not limited to: u2022 Operation of the Laboratory Autoclave and Glassware Washer. u2022 Enumeration and Verification of sample plates and canisters. u2022 Laboratory waste disposal. u2022 Sample Receipt and Reconciliation. u2022 Documentation of sample collection and testing. u2022 Peer review of sampling/testing results. u2022 Paperwork filing. u2022 Conduct investigations, special projects, or other non-routine sampling/testing as required. u2022 Conduct training for more junior analysts in new and existing procedures, techniques and governmental regulations as directed by supervisor. u2022 Mentor analysts by providing technical knowledge and support in resolving technical problems and reviewing documents. u2022 Takes initiative; seeks out additional assignments, etc. u2022 Performs other duties as assigned by management Department Specific/Non-Essential Functions: u2022 Work safely in accordance with regulations, standards, and procedures and in a manner that eliminates unreasonable risk to health and the environment. u2022 Notify management of unsafe conditions or practices, unlawful activities and activities which present unreasonable health and/or environmental risk. u2022 Report all safety and/or environmental incidents to management immediately. u2022 Performs other duties as assigned by management Skills Microbiology, environmental monitoring, GMP, Data Analysis Top Skills Details Microbiology,environmental monitoring,GMP,Data Analysis Additional Skills & Qualifications Education, Experience, and/or Skill: u2022 BS in Microbiology, Biology, or in similar life science preferred. u2022 Minimum 4+ years laboratory experience, preferably in the pharmaceutical industry. u2022 Ability to perform: Environmental monitoring of clean rooms and facility water systems, kinetic LAL, gel-clot LAL, filtration testing, particulate matter testing, 14-day sterility testing, and operation of laboratory equipment (Autoclave, Glassware Washer, etc.). u2022 Knowledgeable of aseptic techniques, clean room behaviors, MC Excel, PowerPoint, Access, and investigation writing. u2022 Ability to train personnel on various procedures and demonstrates effective communication with both team members and other plant support groups. Cognitive Requirements: u2022 Good interpersonal and verbal/written communication skills. u2022 Able to use computer for data analysis. u2022 Knowledge of laboratory safety, material safety; working knowledge of cGMPs, GLPs, and FDA requirements. u2022 Self-motivated, energetic, enthusiastic, and team oriented. Experience Level Intermediate Level Job Type & Location This is a Contract position based out of Raleigh, NC. Pay and Benefits The pay range for this position is $32.00 - $40.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: u2022 Medical, dental & vision u2022 Critical Illness, Accident, and Hospital u2022 401(k) Retirement Plan u2013 Pre-tax and Roth post-tax contributions available u2022 Life Insurance (Voluntary Life & AD&D for the employee and dependents) u2022 Short and long-term disability u2022 Health Spending Account (HSA) u2022 Transportation benefits u2022 Employee Assistance Program u2022 Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Raleigh,NC. Application Deadline This position is anticipated to close on Apr 20, 2026. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through: + Hiring diverse talent + Maintaining an inclusive environment through persistent self-reflection + Building a culture of care, engagement, and recognition with clear outcomes + Ensuring growth opportunities for our people Actalent is an equal opportunity employer. About Actalent Actalent is a global leader in engineering and sciences services. For more than 40 years, weu2019ve helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APACu2014with four delivery centers in India led by 1,000+ extraordinary employees who connect their passion with purpose every day. Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at .

Created: 2026-04-08

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