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0-5 years of experience
Led microbiological testing services to ensure the safety and quality of food, water, and cosmetic products for clients of this ISO 17025 certified contract laboratory.
- Executed water testing on behalf of both manufacturing industry clients as well as private individuals with well water samples.
- Engaged in environmental monitoring for clients, testing and evaluating equipment, facility surfaces and atmospheric conditions using swabbing, RCS air sampler, Contact (RODAC) and Settle Plates.
- Leveraged expertise in United States Pharmacopeia (USP) methods <32>, < 61>, and <62> to test and report findings of cosmetic, personal care, and pharmaceutical products manufactured by nationally known clients.
- Contributed additional service and expertise performing Preservative Efficacy Challenge testing in accordance with USP <51>.
- Served as a subject matter expert to clients, providing guidance and direction with respect to laboratory safety procedures and aseptic sample collection.
- Maintained the integrity of the laboratory through the introduction of weekly lab cleaning and maintenance procedures.
0-5 years of experience
Microbiologist for two production facilities manufacturing raw and ready-to-eat products
- Directed and managed all sampling and testing of products from production facilities
- Monitored product and environmental results for trends with action taken as needed
- Resolved microbial issues and concerns by working with Sanitation and Production supervisors
- Wrote and updated lab SOPs, audited production GMPs, and reviewed HACCP programs.
- Reduced testing costs and made needed improvements in the laboratory.
0-5 years of experience
Responsible for the testing of food samples using various microbiological analyses. Prepared sample for processing and maintained documentation of process to facilitate analysis procedures.
- Read, calculated and recorded analysis data to produce a report for the client. Corrected any discrepancies that occurred.
- Pipetted sample solution into tubes or plates according to analysis being performed. Poured agars into plates, incubated plates and/or tubes to begin growth process
- Performed rapid test methods when requested
- Performed confirmation testing to identify strains of bacteria
- Assisted other departmental personnel with analysis procedures
0-5 years of experience
Responsible for Environmental Monitoring (EM) of all controlled, ISO 8, ISO 7, and ISO 5 areas, as well as compressed gas and water system testing; sterile gowning qualified
- Collected air viable, surface viable, and non-viable particle samples throughout the facility; tested for total hydrocarbon
- Conducted EM and personnel monitoring during batch production and filling
- Wrote and reviewed annual and quarterly trend reports for environmental, water, and clean utilities monitoring
- Manipulated spreadsheets in Excel to analyze years of monitoring data to format for trend reports
- Drafted a change control report to bring water conductivity sampling in-house, including new and revised SOPs, materials
- Completed growth promotion on new media lots
- Assisted manufacturing during sampling and bulk filling processes
6-10 years of experience
Responsible for performance of validation studies for irradiation and ethylene oxide sterilization of medical devices.
- Coordinated product bioburden testing program at contract testing laboratory.
- Set up bacterial endotoxin (LAL) testing program for Vascular Solutions products.
- Directed environmental monitoring program of controlled environments at two facilities.
- Implemented antimicrobial studies for biologic products.
- Cost savings of $100,000 for reduced LAL testing of products based on alternative testing.
0-5 years of experience
Led daily in vitro microbiology testing and kill curve assay preparation to support creation of new antibiotics and compounds.
- Contributed to time-sensitive projects, including 144 bacterial strain Conjugation project; 250 Pa and Entero bacterial strain evaluation; and completion of 244 bacterial strains Beta-Lactamase project.
- Set up and assisted in running Rempex's in vitro pharmacodynamics model.
- Prepared/processed 200 bacterial strains for delivery to reference sites and maintained bacterial stock inventory.
0-5 years of experience
Used aseptic technique and under minimal supervision, performed lab testing on raw material and manufacturing components using USP methods for Total Organic Carbon (TOC), Conductivity, Nitrate, Water testing (Bioburden), Endotoxin and etc.
- Collected, processed, and tested samples of chemical components, bulk products, finished products, and in process material followed by Standard Operating Procedures (SOPs).
- Reviewed and evaluated raw materials and data for acceptability.
- Performed Gram Stain and microscopic examination of physiological, morphological, and cultural characteristics of bacteria and other micro-organisms according to standard microbiological methods and preparing reports with the results.
- Carefully read and tabulated test results entering all data into the LIMS or paperwork as required.
- Maintained weekly inventory of testing supplies, temperature monitoring, water samples collection and testing and environmental monitoring.
- Reviewed equipment charts for specification compliance.
6-10 years of experience
Worked on the development of a new bacterial identification system for clinical laboratories.
- Studied the feasibility and worked on the optimization of differential biochemical tests for identification of gram positive cocci and built a database
- Coordinated development trials and helped transition the product from the research laboratory to production
- Performed validation studies, shelf life studies and selected QC strains in order to build the QC matrix
- Trained new members joining the project
6-10 years of experience
Reviewed cGMP, cUSP guidelines and updated SOPs to ensure laboratory compliance, supported applicable departments with product specific issues, investigations, verifications and validations, and analyzed samples using microbial and wet chemistry techniques and analytical instruments (Karl Fischer, UV-Vis, HPLC, GC, and TOC). Monitored staff's work performance to help establish goals, delegate responsibilities and stimulate career development.
- Achieved continual safety awareness and work practices through implemented safety procedures.
- Reduced reoccurrence of out-of-specification (OOS) investigations by identifying root causes using procedure and process checklist.
- Increased work flow and productivity by organizing work flow charts and streamlining worksheets to be user friendly.
- Improved personnel development by implementing training systems and manuals that captured various learning styles, identified areas of improvement and facilitated resolutions.
6-10 years of experience
Performed microbial testing on raw materials and finished product samples
- Trained and supervised three employees to assure compliance to regulations
- Performed challenge testing to validate preservative levels
- Prepared and qualified various microbial media used in product and water testing
- Utilized gram staining and selective media to identify organisms
- Conducted product process validation and cleaning validations
- Adhered to SOP, cGMP, MSDS, and FDA requirements
- Knowledge of GC, FTIR, & HPLC in determining active ingredient concentrations
0-5 years of experience
Managed the accuracy of testing and reporting of HIV, hepatitis, and syphilis serum specimens
- Applied microbiology and customer service skills in order to field infectious disease and protocol
- Strictly adhered to HIPAA and CLIA standards for privacy and technical quality
- Developed QA protocol as laboratory Safety Committee member
- Utilized GS HIV-1/HIV-2 Plus O EIA; an enzyme immunoassay for detection of HIV antibodies within patient serum as well as Rapid Plasma Reagin card test for detection of syphilis associated
0-5 years of experience
Contracted through the U.S. Department of Homeland Security for testing within a BSL Level 3 Lab.
- Proficient and a top performing Microbiologist, assigned to work in a highly sensitive laboratory, charged with testing selected agents and performing real-time PCR testing.
- Perform daily LAL Endotoxin testing.
- Use the autoclave on a daily basis and schedule PM.
0-5 years of experience
Performed environmental monitoring, aseptic and non-aseptic, air and surface samples with Batch Record Review.
- Reviewed data, generated trends and reports, wrote and edited SOP's.
- Performed investigations of alert and exceeded action levels and/or trends in microbial monitoring data, and provided corrective action plans and follow up.
- Managed lab in media preparation, sterilization, problem solving, and training.
- Familiarity with cGMP's, OSHA, EPA, FDA, USP and ISO policies and compliance.
0-5 years of experience
Provided primary support in the processing of samples in the General Support/R&D Division that include, but are not limited to: bioburden, toxicity, antimicrobial efficacy, microbial kill time, sterility testing, LAL, and water purifier.
- Performed monthly culture maintenance, stock preparation, and organism identification.
- Carried out all applicable corporate and laboratory quality control procedures, including a setup of control charting spike samples and proficiency test samples.
- Coordinated media and reagent preparation.
- Reviewed and authored applicable Standard Operating Procedures (SOP).
0-5 years of experience
Responsible for providing leadership and support for environmental monitoring operations and for ensuring microbial testing adhered to Alkermes Environmental Monitoring standards
- Executed, compiled data, and composed validation report for the EM Compressed Gas protocol
- Discovered sampling discrepancy in a compressed gas validation protocol preventing non-compliance and reducing potential for product recall across product lines
- Coached and mentored new employees, sharing expertise and knowledge on industry and company SOPs to ensure their adherence to GMP standards
- Oversaw Environmental Monitoring and Utility sampling/testing to ensure downtime from non-compliance issues were kept to a minimum
- Responded to out of compliance conditions within the aseptic filling suites and ensured the integrity of the product was not compromised
- Qualified trainer for Clean Room access and Sterile Gowning
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