Job Summary: 

• Perform routine microbiological testing of products and /or raw material according to SOPs and Methods.
• Document the routine test data following the laboratory and company guidelines, and report OOS
• Review and approve data generated by other microbiologists.
• Perform environmental monitoring, document the test data, and report the OOS.
• Perform microbiological identifications.
• Coordinate and track testing data reports as required by the other Departments.
• Assist in generating investigation and/or summary reports under the supervision of the Microbiology Supervisor.
• Perform the microbiological support for media fill inspection as per SOPs.
• Assist in the generation of outside source information retrieval and evaluation in support of special project work.
• Perform bioassay testing.
• Prepare media and perform the growth promotion test.

Skills on Resume: 

• Microbiological Testing (Hard Skills)
• Data Documentation (Hard Skills)
• OOS Reporting (Hard Skills)
• Environmental Monitoring (Hard Skills)
• Microbial Identification (Hard Skills)
• Report Coordination (Soft Skills)
• Investigation Support (Soft Skills)
• Media Preparation (Hard Skills)

Job Summary: 

• Support new equipment qualification and new laboratory setup.
• Perform transfer, verification, and validation of laboratory procedures within the team.
• Prepare technical documentation, including protocols, analytical write-ups, standard operating procedures, specifications, investigations, and reports.
• Perform quality control microbiological testing of incoming goods, intermediates, and finished products under cGMP conditions for QC release or stability studies.
• Manage microbiology chemical supplies, reference standards, and consumable stock levels.
• Support microbiological environmental monitoring of facility areas, utilities, and personnel.
• Review analytical and laboratory data for accuracy, completeness, and compliance with documented procedures.
• Perform planned preventative maintenance and performance calibrations on equipment.
• Maintain personal training records.
• Participate in continuous improvement activities.
• Communicate effectively with colleagues on-site and internationally.
• Ensure cGMP is applied in all work activities and comply with cGMP across the business.
• Work with HSE, cGMP, and 5S principles in mind at all times.

Skills on Resume: 

• Equipment Qualification (Hard Skills)
• Procedure Validation (Hard Skills)
• Technical Documentation (Hard Skills)
• Microbiological Testing (Hard Skills)
• Supply Management (Soft Skills)
• Environmental Monitoring (Hard Skills)
• Data Compliance Review (Hard Skills)
• Equipment Maintenance (Hard Skills)

Job Summary: 

• Work under the supervision of other scientists on problems of limited scope where data analysis requires evaluation of identifiable factors, demonstrating potential for technical proficiency and scientific creativity.
• Perform compendial microbial testing of raw materials, in-process materials, and finished products within scheduled timelines under scientific supervision.
• Perform environmental sampling and testing.
• Perform USP water sampling and testing.
• Perform identification of microorganisms.
• Maintain notebooks in accordance with GMP standards and SOPs, accurately report results, and provide detailed records of findings and conclusions.
• Provide written and verbal updates on projects and activities.
• Work with quality systems such as Compliance Wire, TrackWise, and Documentum.
• Assist other scientists for timely project completion and support laboratory personnel.
• Comply with health, safety, and environmental responsibilities for the position.

Skills on Resume: 

• Scientific Data Evaluation (Hard Skills)
• Compendial Microbial Testing (Hard Skills)
• Environmental Sampling (Hard Skills)
• USP Water Testing (Hard Skills)
• Microorganism Identification (Hard Skills)
• GMP Documentation (Hard Skills)
• Project Communication (Soft Skills)
• Quality Systems (Hard Skills)

Job Summary: 

• Perform microbiological and cell-based assays within the QC function.
• Write protocols, reports, and transfer documentation to support assay transfer between Development and QC.
• Perform routine microbiological testing of raw materials, in-process materials, and finished products in compliance with Health and Safety policies.
• Provide accurate and reliable laboratory assay results to cGMP standards in compliance with regulatory requirements and SOPs.
• Ensure activities are performed according to current SOPs and inform the QC Manager of any deviations.
• Ensure appropriate standards of housekeeping, safety, and discipline are maintained.
• Perform additional testing in other departments.
• Assist in coordinating daily activities in the Microbiology laboratory.
• Oversee fermentation microbiology upstream processes, including inoculum development and fermenter in-process quality.
• Record, review, and store laboratory-generated data accurately.
• Maintain compliance with all company systems and procedures.

Skills on Resume: 

• Microbial Cell Assays (Hard Skills)
• Protocol Report Writing (Hard Skills)
• Routine Micro Testing (Hard Skills)
• cGMP Assay Compliance (Hard Skills)
• SOP Deviation Reporting (Soft Skills)
• Lab Housekeeping (Soft Skills)
• Cross-Department Testing (Hard Skills)
• Micro Lab Coordination (Soft Skills)

Job Summary: 

• Coordinate, review, and approve product sterilization validations, including gamma sterilization, dose map reviews and approvals, ETO sterilization validation, and routine monitoring.
• Develop independent sterilization validation groups to mitigate the risk of dose audit failures.
• Release ETO and gamma sterilization certificates.
• Create and approve internal technical documents.
• Participate in internal and external audits as a subject matter expert.
• Create technical reviews, specifications, and mandatory documents related to sterilization and biological evaluation for regulatory submissions.
• Serve as a resource for sterilization and cleaning issues in new product development.
• Order and track microbiology laboratory analyses, including organism identification, bacterial endotoxin testing, bioburden testing, and dose audit testing.
• Conduct biocompatibility assessments and organize required testing.
• Perform cleanroom IQ, OQ, and PQ validations and provide support for cleanroom design, validation, and troubleshooting.

Skills on Resume: 

• Sterilization Validation (Hard Skills)
• Dose Risk Mitigation (Hard Skills)
• Sterilization Certificate Release (Hard Skills)
• Technical Document Control (Hard Skills)
• Audit Participation (Soft Skills)
• Regulatory Document Preparation (Hard Skills)
• Product Development Support (Soft Skills)
• Microbiology Testing Coordination (Hard Skills)

Job Summary: 

• Provide detailed, professional microbiological support to ensure all products and ingredients are free of microbial contamination.
• Arrange for the collection of sterilized samples from the fumigator and other samples from various plant areas.
• Prepare and organize samples for analysis in designated work areas.
• Prepare standard and specialized media for the work area and maintain detailed working knowledge of instruments and equipment, along with general knowledge of all laboratory equipment.
• Perform routine microbiological analyses, including Salmonella, coliform, total plate counts, and yeast and mold counts, as well as specialized analyses for method development or upon request.
• Perform environmental sampling and monitor sanitation microbiologically throughout the plant.
• Prepare data, analyses, and summary reports.
• Keep a daily log of work performed.
• Keep a daily record of all material in the sterilization room.
• Ensure total product amounts correlate between computer printouts, production reports, product logs, and actual counts.
• Ensure all microbiological specifications are met.
• Perform product releases for shipments and issue holds and releases.
• Interface with scheduling, warehouse, production, and other departments to coordinate analyses and make the product available for shipment.
• Monitor supplies in the work area and arrange purchases of supplies and new equipment.
• Ensure safety in the work area.

Skills on Resume: 

• Microbiological Support (Hard Skills)
• Sample Collection Coordination (Hard Skills)
• Sample Preparation (Hard Skills)
• Media Preparation (Hard Skills)
• Microbial Analysis (Hard Skills)
• Environmental Monitoring (Hard Skills)
• Data Reporting (Soft Skills)
• Cross-Department Coordination (Soft Skills)

Job Summary: 

• Perform sampling according to Standard Operating Procedures, including the required documentation such as sample label generation and SAP transactions.
• Perform routine and non-routine quality monitoring and sampling of utility systems, including purified water, water for injection, pure steam, compressed air, and nitrogen systems.
• Perform routine and non-routine environmental monitoring for all required plants, facilities, cleanrooms, hygienic areas, and laboratories, including particle monitoring tests.
• Perform personnel qualification and re-qualification activities, as well as qualification and re-qualification of cleanrooms.
• Perform routine and batch-related environmental monitoring in cleanrooms, production areas, and laboratories.
• Carry out equipment cleaning, sampling, and facility cleaning activity sampling.
• Ensure assigned tasks are performed promptly in accordance with SOPs, current GMPs, and GLPs while following necessary safety precautions.
• Maintain complete and accurate records of all sampling performed in relevant logbooks and worksheets.
• Report anomalies such as out-of-specification results, out-of-alert results, and atypical events encountered during sampling, testing, or equipment calibration and verification.
• Provide documentation support by participating in writing or revising trend reports, SOPs, protocols, test reports, and other work assigned by senior staff or microbiology management.
• Ensure cleanliness and proper maintenance of sampling tools and equipment.
• Conduct work in accordance with company EHS procedures, guidelines, and expectations, and demonstrate best EHS practices.

Skills on Resume: 

• Sampling Procedures (Hard Skills)
• Utility Monitoring (Hard Skills)
• Environmental Monitoring (Hard Skills)
• Personnel Qualification (Hard Skills)
• Cleanroom Monitoring (Hard Skills)
• Cleaning Activity Sampling (Hard Skills)
• Record Maintenance (Hard Skills)
• Documentation Support (Soft Skills)

Job Summary: 

• Author and review verification, qualification, and comparability protocols and reports for bioburden, endotoxin, sub-visible particles, identification of bacterial species via MicroSeq, BacT testing of bulk harvest, and container closure testing.
• Liaise with external collaborators, contract laboratory organizations, QC testing teams, and QA groups.
• Ensure training needs, internal procedures, specifications, and protocols are met and ensure compliance with pharmacopoeias and ICH guidelines.
• Provide analytical method support to the QC testing team, including Out-of-Specification investigational support as a subject matter expert.
• Assess change controls such as vendor changes, compendial updates, and customer updates to raw material specifications.
• Assist in maintaining good housekeeping in work areas.
• Maintain positive working relationships among employees and foster an environment of engagement, empowerment, teamwork, and accountability.

Skills on Resume: 

• Protocol Review (Hard Skills)
• External Collaboration (Soft Skills)
• Training Compliance (Hard Skills)
• Method Support (Hard Skills)
• Change Control Assessment (Hard Skills)
• Housekeeping Support (Soft Skills)
• Team Relationship Building (Soft Skills)
• Employee Engagement Support (Soft Skills)

Job Summary: 

• Conduct sterilization qualification for new products and/or changes to existing products.
• Perform sterilization validation for radiation sterilized products, including dose setting and quarterly dose audits.
• Perform sterilization validation for ethylene oxide sterilized products, including new product qualification, annual revalidations, residual EO studies, and D-value studies.
• Conduct an Ethylene Oxide Biological indicator sterility positive investigation.
• Comply with all company policies and procedures, including safety rules and regulations.
• Maintain a safe work environment and function safely.

Skills on Resume: 

• Sterilization Qualification (Hard Skills)
• Radiation Validation (Hard Skills)
• EO Validation (Hard Skills)
• BI Investigation (Hard Skills)
• Policy Compliance (Soft Skills)
• Safety Adherence (Soft Skills)
• Safe Work Practices (Soft Skills)
• Product Qualification Support (Hard Skills)

Job Summary: 

• Write SOPs in accordance with ISO specifications and perform all laboratory procedures to the required standards.
• Assist in improving the performance of existing products to comply with IVDD and IVDR regulations.
• Research, analyze, and apply information for new product development and improvement.
• Deliver development work to meet specific project milestones defined by project timelines.
• Prepare and present written reports and documents.
• Review literature related to investigations, enhance experimental design, and carry out research studies.
• Support senior staff in providing high-quality technical service and assisting with validation studies.
• Participate in laboratory project meetings.

Skills on Resume: 

• SOP Writing (Hard Skills)
• Product Improvement (Hard Skills)
• Research Analysis (Hard Skills)
• Project Delivery (Soft Skills)
• Report Preparation (Hard Skills)
• Literature Review (Hard Skills)
• Technical Support (Soft Skills)
• Project Meeting Participation (Soft Skills)

Job Summary: 

• Maintain familiarity with the Jarrow Formulas product lines and raw materials, including excipients used in manufacturing, and thorough knowledge of analytical techniques used in the Jarrow laboratories.
• Actively utilize cGMPs to ensure proper handling of dietary supplements in a controlled environment.
• Prepare media and necessary reagents.
• Perform various microbiology tests and assays in strict accordance with SOPs on time and write reports.
• Perform preventative maintenance on laboratory instruments, machines, and apparatuses.
• Perform literature searches for analytical methods and revise or create SOPs.
• Perform independent method verification, method transfer, and method validation.
• Operate laboratory instruments, machines, and apparatuses properly.
• Clean glassware and other labware properly.
• Log incoming samples and record analytical results and other laboratory work.
• Track and maintain inventory of chemicals, test media, consumables, and glassware.
• Search catalogues and create purchase requisitions.
• Communicate with internal and external clients, outside vendors, and instrument technicians or repair personnel.
• Keep management apprised of any conditions or findings that may impact production schedules, including issues requiring customer contact.
• Participate in lab group meetings and in-house or external training to enhance analytical knowledge and productivity.
• Instruct and teach other lab personnel microbiology techniques and assays.

Skills on Resume: 

• Product Knowledge (Hard Skills)
• cGMP Handling (Hard Skills)
• Media Preparation (Hard Skills)
• Microbiology Testing (Hard Skills)
• Instrument Maintenance (Hard Skills)
• Method Validation (Hard Skills)
• Inventory Management (Soft Skills)
• Client Communication (Soft Skills)

Job Summary: 

• Perform daily microbiology testing of laboratory samples.
• Analyze samples using established methods.
• Maintain the laboratory database.
• Prepare microbiology media and reagents.
• Assist other microbiologists.
• Record process parameters accurately, accountably, and on time on specified documents.
• Use and care for laboratory instruments, equipment, and reagents properly.
• Interpret data and observations in the laboratory.
• Maintain a safe and clean laboratory.

Skills on Resume: 

• Microbiology Testing (Hard Skills)
• Sample Analysis (Hard Skills)
• Database Maintenance (Hard Skills)
• Media Preparation (Hard Skills)
• Microbiology Assistance (Soft Skills)
• Parameter Recording (Hard Skills)
• Instrument Handling (Hard Skills)
• Data Interpretation (Hard Skills)

Job Summary: 

• Provide support for strengthening laboratory systems in international settings, particularly resource-limited regions in the country, to improve bacterial meningitis detection, outbreak prevention and response, and vaccination strategy development.
• Coordinate and participate in laboratory capacity-building activities in collaborating countries by developing training materials, delivering laboratory training, providing technical assistance, and planning and implementing activities that ensure sustained testing and strong laboratory performance.
• Coordinate and communicate with country partners and implementing partners to ensure timely and successful implementation of activities aimed at improving laboratory diagnosis, data management, and quality.
• Track in-country activities and prepare internal and external updates and reports promptly.
• Prepare and track budgets, expenses, and laboratory orders using effective tools for specific countries.
• Assess the needs of collaborating laboratories annually and develop operational plans to address identified gaps.
• Participate in special research studies within the network and support outbreak response and related activities.
• Prepare progress reports, summaries, presentations, papers, and other documents to highlight findings, accomplishments, and surveillance data.

Skills on Resume: 

• Laboratory System Support (Hard Skills)
• Capacity Building (Soft Skills)
• Partner Coordination (Soft Skills)
• Activity Tracking (Hard Skills)
• Budget Management (Hard Skills)
• Laboratory Needs Assessment (Hard Skills)
• Outbreak Response Support (Hard Skills)
• Report Preparation (Soft Skills)

Job Summary: 

• Conduct testing under compendial methods such as BAM, CTFA, SMWW, USP, and internal SOPs.
• Ensure that incoming samples are properly tested and documented.
• Interpret microbiological results and write technical protocols and reports.
• Ensure compliance with cGMP systems and applicable SOPs.
• Plan and participate in client and internal microbiological studies and special projects.
• Utilize technical abilities to solve complex problems, resolve client issues, and investigate OOS results.
• Maintain a safe work environment in a cGMP-FDA-regulated environment according to OSHA Laboratory Standards.
• Ensure timely execution of equipment maintenance, calibration, and documentation.

Skills on Resume: 

• Compendial Testing (Hard Skills)
• Sample Documentation (Hard Skills)
• Result Interpretation (Hard Skills)
• cGMP Compliance (Hard Skills)
• Study Planning (Soft Skills)
• Problem Solving (Soft Skills)
• Safety Adherence (Soft Skills)
• Equipment Maintenance (Hard Skills)

Job Summary: 

• Support and arrange laboratory activities related to environmental monitoring for viable organisms using air sampling and contact plates for surfaces.
• Perform WFI sampling and microbiological and chemical testing.
• Perform compressed gases sampling and testing for viable and non-viable content.
• Perform microbial enumeration testing for in-process and drug substance samples.
• Perform cleaning validation and verification for microbiological samples.
• Perform growth promotion testing for in-house prepared or ready-prepared media.
• Perform bacterial endotoxin testing for in-process and drug substance samples.
• Evaluate and trend laboratory data.
• Ensure housekeeping and maintain inventory of consumables and media.
• Participate in the optimization of test procedures and Lean Lab initiatives to improve efficiency and productivity of the microbiology laboratory.
• Create and revise SOPs, work instructions, JTOs, and TTOs related to the microbiology laboratory.

Skills on Resume: 

• Environmental Monitoring (Hard Skills)
• WFI Testing (Hard Skills)
• Gas Sampling (Hard Skills)
• Microbial Enumeration (Hard Skills)
• Cleaning Validation (Hard Skills)
• Growth Promotion Testing (Hard Skills)
• Endotoxin Testing (Hard Skills)
• Data Trending (Hard Skills)

Job Summary: 

• Carry out responsibilities in accordance with organizational policies, procedures, and applicable state, federal, and local laws.
• Comply with all safety rules and regulations.
• Perform water sampling of up to 50 lbs and log information into the LIMS system.
• Perform water testing and enter results into the LIMS system.
• Perform environmental monitoring for surface and air.
• Log microbial identifications and Gram stain results into the LIMS system.
• Receive samples, as well as media and laboratory supplies.
• Prepare media and conduct media qualification.
• Perform culture preparation.
• Calibrate balances and calibrate and operate pH meters.
• Perform preventative maintenance on laboratory equipment.
• Write and create equivalency reports.
• Write laboratory investigation reports.
• Perform microbial limits testing on finished products, raw materials, and stability samples.
• Review team member data.

Skills on Resume: 

• Policy Compliance (Soft Skills)
• Safety Compliance (Soft Skills)
• Water Sampling (Hard Skills)
• Environmental Monitoring (Hard Skills)
• LIMS Data Entry (Hard Skills)
• Media Preparation (Hard Skills)
• Equipment Calibration (Hard Skills)
• Microbial Limits Testing (Hard Skills)

Job Summary: 

• Ensure GMP compliance in all microbiology laboratory activities.
• Write protocols for testing, validation, and laboratory operations.
• Perform disinfectant efficacy testing and validation.
• Conduct endotoxin testing, sterility testing, antimicrobial effectiveness testing, environmental monitoring, water testing, microbial limits testing, and bioburden testing.
• Qualify and validate test methods.
• Carry out quality control checks.
• Assist in laboratory investigations.
• Trend laboratory data to identify patterns or issues.
• Update SOPs.
• Provide training to other members of the microbiology team.
• Proactively identify and implement laboratory process improvements.

Skills on Resume: 

• GMP Compliance (Hard Skills)
• Protocol Writing (Hard Skills)
• Disinfectant Validation (Hard Skills)
• Microbiology Testing (Hard Skills)
• Method Validation (Hard Skills)
• Quality Control Checks (Hard Skills)
• Laboratory Investigation Support (Soft Skills)
• Data Trending (Hard Skills)

Job Summary: 

• Perform lab bench microbiological tests and data analysis according to departmental SOPs.
• Perform sterility testing using isolator technology in compliance with departmental SOPs.
• Perform microbiological tests in support of the customer return program.
• Harvest and standardize challenge microorganisms using a spectrophotometer.
• Prepare sterile media and solutions required for testing.
• Provide expertise and guidance for microbiology-related work.
• Review and approve microbiology raw data sheets, study files, and supporting data in accordance with SOPs and regulations.
• Guide and document investigation activities within the group.
• Evaluate, improve, and qualify new and existing methods and procedures with limited guidance.
• Author and review technical reports, CFRs, and SOPs.
• Use change management to document method changes in compliance with standards and regulations.
• Maintain a safe and compliant work environment by following standards, procedures, and company regulations.

Skills on Resume: 

• Microbiological Testing (Hard Skills)
• Sterility Testing (Hard Skills)
• Return Program Testing (Hard Skills)
• Microorganism Standardization (Hard Skills)
• Media Preparation (Hard Skills)
• Microbiology Guidance (Soft Skills)
• Data Review (Hard Skills)
• Investigation Support (Soft Skills)

Job Summary: 

• Receive and control microbiological samples submitted for testing in the Microbiology Laboratory.
• Perform microbiological testing according to laboratory methodology, including testing standards, general methods, specific methods, pharmacopeial compendia, and SOPs, and perform sampling of water, environmental air, surface samples, and compressed air.
• Report analytical test results in applicable computerized systems.
• Review laboratory documentation from peers to ensure testing was performed accurately and according to laboratory methodology.
• Perform and document laboratory investigations and quality event investigations, and generate investigations for test results outside specification and for quality events.
• Recommend updates to current SOPs, protocols, and monographs.
• Prepare and sterilize culture media and laboratory solutions, and perform growth promotion, sterility, and viability tests on culture media.
• Identify microorganisms according to laboratory methodology and ensure adequate inventory of purchased microorganisms, culture media, reagents, and laboratory supplies.
• Verify calibration of laboratory equipment to ensure suitability for use.
• Participate in microbiological testing validation exercises.
• Assist in training newly hired microbiologists.
• Handle and properly dispose of potentially dangerous or regulated hazardous waste in designated disposal facilities or storage containers and complete required logs and forms, and take corrective action in the event of spills, fires, or explosions.
• Ensure reliability of analytical equipment and maintain integrity of testing areas through proper maintenance and housekeeping according to 5S principles.
• Maintain accurate records of all work performed and document testing results according to Good Documentation Practices and QC SOPs.
• Complete required microbiology qualification programs annually and maintain an updated qualification file.
• Understand, interpret, and apply compendial testing.
• Ensure laboratory materials are within expiry and follow internal inventory systems for documenting received and discarded materials.
• Generate laboratory work orders in the computerized Maximo system.

Skills on Resume: 

• Microbiology Sample Control (Hard Skills)
• Microbiological Testing (Hard Skills)
• Data Reporting (Hard Skills)
• Documentation Review (Hard Skills)
• Investigation Management (Hard Skills)
• Media Preparation (Hard Skills)
• Equipment Calibration (Hard Skills)
• Microbiologist Training (Soft Skills)

Job Summary: 

• Review daily results and paperwork from Environmental, Particulate Matter, and Pyrogen laboratories, and support paperwork review from sterilizer qualifications.
• Read and document the results of appropriately incubated samples.
• Address out-of-limit and positive test results by performing trending analysis, retest procedures, Gram staining, thermal death testing, and microscopic analysis, and review and sign off on completed paperwork before submission to the Documentation Centre.
• Compile data required for monthly, quarterly, and annual trending.
• Coordinate required testing and compile and review the resulting data for critical work requests and validations.
• Conduct sterility testing for stability and import samples, qualification studies, and requalifications using open and closed method filtration, drop tests, and macerations in accordance with SOPs and complete all required documentation.
• Collect and organize production samples and check for discrepancies against sterilized sample records.
• Maintain testing equipment and areas to ensure endotoxin-free conditions and perform bacterial endotoxin testing per specification.
• Compile data required for monthly, quarterly, and annual trending.
• Perform required testing and complete documentation for critical work requests and protocols by prioritizing daily and weekly schedules, and assist in OOL and CAPA investigations and audit resolution.
• Participate in and support plant projects and validations.
• Drive continuous improvement of environmental controls by performing real-time risk assessments in classified areas and supporting improvement projects and validations.
• Provide backup support to the Sterility Assurance Department.
• Maintain equipment inventories and order laboratory supplies, and ensure timely equipment calibrations.
• Prepare and sterilize laboratory equipment, dispose of biohazard materials appropriately, and perform monthly preventive maintenance.
• Monitor incubator and refrigerator charts and thermometers daily.
• Maintain 6S within assigned lab areas.

Skills on Resume: 

• Result Review (Hard Skills)
• Trending Analysis (Hard Skills)
• Testing Coordination (Hard Skills)
• Sterility Testing (Hard Skills)
• Sample Management (Hard Skills)
• Endotoxin Testing (Hard Skills)
• CAPA Support (Soft Skills)
• Inventory Maintenance (Hard Skills)