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10+ years of experience
Performed testing to support release of raw materials, in-process materials and finished products (Allegra D24, Carafate Suspension & Gaviscon). Worked cross functionally to mitigate batch losses.
- Evaluated samples for the presence of objectionable microbial organisms using manual techniques and automated Vitek II Microbial Identification System.
- Conducted environmental monitoring and water testing in critical manufacturing & packaging areas. Met 100% annual analyst proficiency requirements.
- Prepared microbiological growth media & solutions and ensured media performance through QC testing.
- Performed annual temperature mapping re-qualification (Validator 2000) of facility autoclaves and temperature control systems.
- Knowledgeable in antimicrobial effectiveness testing (AET) of stability samples.
- Wrote and executed validation protocols (IQ/OQ/PQ) for evaluation and implementation of new automated laboratory equipment.
- Represented microbiology lab during FDA, EP and JP regulatory audits.
- Wrote quarterly & annual reports for USP Purified Water and environmental trending data.
0-5 years of experience
- Performed sterility testing on the purified water system, raw materials, and finished products using Neogen’s Soleris rapid microbiological technology
- Conducted FTIR, disintegration time, hardness and thickness tests on all applicable products
- Created certificates of analysis
- Created and reviewed S.O.P.s relevant to the Quality Control department
0-5 years of experience
Primarily responsible for writing new procedures for the new Quality Control Microbiology Lab. Also responsible for validating new equipment for Endotoxin testing and qualifying equipment for environmental monitoring testing.
- Prepare new microbiology lab for product release testing including Endotoxin testing and Biological Indicator testing; including planning and purchasing supplies needed for testing.
- Environmental monitoring on a quarterly basis and as needed of Class 7 and 8 cleanrooms and a Class 5 Isolator.
- Create and update procedures to include the new lab and new tests.
- Writing protocols for validating or qualifying equipment.
- Work with other departments to ensure that all of the equipment and supplies are ready for use.
10+ years of experience
- Performed microbiological testing on raw materials, in-process products, bulk products, finished products, and purified water for product release in a timely manner for this FDA licensed manufacturer of personal care products
- Sampled, tested, and approved all incoming raw materials
- Prepared all media, diluents, and stock cultures for the microbiology laboratory
- Conducted periodic environmental monitoring in the manufacturing area and production lines
- Documented all results of product testing and maintained daily records using Microsoft Word and Microsoft Excel
- Aided the Director of Quality Assurance in preparing and revising SOPs
- Ordered supplies for the microbiology and research and development laboratories
- Participated on the safety committee
0-5 years of experience
- Managed company operations by verifying all completed documents, while following SOP and GMP regulations.
- Tested quality of raw materials, and finished products by analyzing microbial plates using proper pour plate method, spread plate method & inoculation of media.
- Performed environmental testing for all testing, manufacturing, and packaging work environments.
- Created batch records and internal purchase orders for new and approved finished products.
- Created SOPs and bill of materials for Microbiological test methods, and methods in creating agar plates, and broth in reference to USP standards.
- Performed FTIR scans, atomic absorption, and UV-Vis to identify and quantify materials.
- Performed HPLC to identify and quantify enzymes & used TLC method to identify vitamins and omegas.
- Held meetings through presentations to uphold regulatory standards & made proposals for company improvements.
0-5 years of experience
- Conducts weekly Environmental Monitoring of ISO 5 and ISO 7 clean rooms
- Tests batch samples for in process testing and finished goods testing
- Tests equipment qualification and validation samples for particulate and endotoxin
- Helps identify types of bacteria found during sampling
- Assists with creation of trending reports and sample collection
0-5 years of experience
- Manage all aspects of multiple microbiological tests.
- Communicate test status and timelines.
- Analyze test results and compile data into written reports.
- Implemented new purchase order system to improve efficiency of the department.
0-5 years of experience
- Perform release testing on finished products following Standard Operating Procedures (SOPs) and in-house test methods
- Report the results of analyses on Certificates of Analysis (COAs)
- Provide documentation of all routine and non-routine microbiological testing performed on raw materials, finished products, and special request samples
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Quality Control Microbiologist
Last edited by: Gabriela Barcenas, CONTENT STRATEGIST -
Gabriela Barcenas
CONTENT STRATEGISTGabriela is a Certified Professional Resume Writer (CPRW) and career adviser. With 10 years of digital media experience and five years of resume writing expertise, her publication history includes fashion, education, travel, social justice, equitable design and career advice.
