Microbiology Analyst Resume Sample
Evan Luettgen
994 Kutch Ferry,
Los Angeles,
CA
+1 (555) 904 5429
Work Experience
QC Senior Microbiology Analyst
11/2015
-
PRESENT
Philadelphia, PA
- Perform routine testing of environmental samples, microbial analysis of water and compressed gases, and microbial analysis of product samples
- Perform required data analysis, compile data and prepare results for review
- Conduct environmental enumeration of viable air samples, microbial identification, bioburden analysis, and sterility testing participate in internal assessments and audits
- Plan own activities on a weekly basis in accordance with established schedules and in accordance with group objectives and priorities
- Interpret test results, compare to established specifications and control limits and makes recommendations on appropriateness of data for release
- Perform microscopic technique/cell counting, utility sampling, environmental monitoring
- Perform wet chemistry testing
- Be responsible for data documentation and technical writing
- Complete quality control laboratory functions
Microbiology Analyst
02/2009
-
05/2015
Houston, TX
- Adhere to aseptic technique
- Technical/Professional Knowledge— having achieved a satisfactory level of technical and professional skill or knowledge in position-related areas; keeping up with current developments and trends in areas of expertise
- Problem Solving— the individual identifies and resolves problems in a timely manner and gathers and analyzes information skillfully
- Communication— the individual speaks clearly and persuasively in positive or negative situations, demonstrates group presentation skills and conducts productive meetings
- Quality Management— the individual looks for ways to improve and promote quality and demonstrates accuracy and thoroughness
- Planning/Organizing— the individual prioritizes and plans work activities, uses time efficiently and develops realistic action plans
- Adaptability – maintains effectiveness when experiencing major changes in work tasks or the work environment; adjusting effectively to work within new work structures, processes, requirements, or cultures
Microbiology Analyst Limerick
03/2005
-
12/2008
Chicago, IL
- Stress Tolerance— maintaining stable performance under pressure or opposition (such as time pressure or job ambiguity); handling stress in a manner that is acceptable to others and to the organization
- Following established SOPs, Analysts collect information about the composition of substances/samples to support the analytical testing needs of our clients for such purposes as quantitative analysis, product development, and improvement of analytical methodologies
- Accurately and efficiently set up and process samples while meeting quality standards and turnaround time expectations
- Senior Analysts/Microbiologist have a key role in staff training and lead training efforts for junior technicians and analysts
- Performs QC microbiological aspects of cGMP compliance and testing
- Participate in the investigation and review of alert and action limit investigations as needed and implements corrective action as appropriate
- Participate in cleaning and process validation activities involving microbiology
- Conducts the investigation of microbiological data deviation results and PRs
- Serve as SME for one or more of the functional streams: utility monitoring, environmental monitoring or material monitoring
Education
University of Saint Mary
1999 - 2004
Bachelor's Degree in Biology
Professional Skills
- Proven skills in environmental monitoring in a manufacturing environment, preferably in pharmaceutical or other regulated industry
- Excellent organizational, communication, interpersonal and report writing skills
- Excellent communication skills, in English and Spanish, oral and written
- Excellent communication skills (verbal and written), and other electronic systems
- Strong and professional communication skills (written and verbal)
- Advanced knowledge of and skills in using computer software and hardware applications, including Microsoft Word and Excel
- Knowledge of and skills in using computer software and hardware applications, including Microsoft Word and Excel
How to write Microbiology Analyst Resume
Microbiology Analyst role is responsible for software, computer, microsoft, basic, manufacturing, hardware, english, leadership, word, excel.
To write great resume for microbiology analyst job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Microbiology Analyst Resume
The section contact information is important in your microbiology analyst resume. The recruiter has to be able to contact you ASAP if they like to offer you the job. This is why you need to provide your:
- First and last name
- Telephone number
Work Experience in Your Microbiology Analyst Resume
The section work experience is an essential part of your microbiology analyst resume. It’s the one thing the recruiter really cares about and pays the most attention to.
This section, however, is not just a list of your previous microbiology analyst responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular microbiology analyst position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Microbiology Analyst resume experience can include:
- Develops and/or contributes toward creating and revising microbiological Standard Operating Procedures (SOPs) and other current Good Manufacturing Practices (cGMP) documentation
- Communication skills: foster open communication, active listening and good communication skills in English and Spanish (oral and written)
- Self starter with strong analytical and self-management skills
- Excellent communication, documentation, and organization skills
- Personal leadership skills and works well with a team
- Demonstrated knowledge of method and equipment validations and qualifications
Education on a Microbiology Analyst Resume
Make sure to make education a priority on your microbiology analyst resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your microbiology analyst experience. For example, if you have a Ph.D in Neuroscience and a Master's in the same sphere, just list your Ph.D. Besides the doctorate, Master’s degrees go next, followed by Bachelor’s and finally, Associate’s degree.
Additional details to include:
- School you graduated from
- Major/ minor
- Year of graduation
- Location of school
These are the four additional pieces of information you should mention when listing your education on your resume.
Professional Skills in Microbiology Analyst Resume
When listing skills on your microbiology analyst resume, remember always to be honest about your level of ability. Include the Skills section after experience.
Present the most important skills in your resume, there's a list of typical microbiology analyst skills:
- Good attention to detail and ability to utilize problem solving/trouble shooting skills
- Intermediate computer skills working with Microsoft office
- Demonstrated knowledge and testing experience in an FDA/IMB approved QC laboratory
- Prior experience in a pharmaceutical microbiology laboratory is highly desirable
- Advanced personal leadership skills and fosters working in a team environment
- BSc in Chemistry / Microbiology or a biological science, with 1 – 3 years’ experience, or equivalent combination of education and experience
List of Typical Experience For a Microbiology Analyst Resume
1
Experience For QC Microbiology Analyst Resume
- Effectively prioritize work and manage time in order to meet deadlines and rush orders
- Gowning clean room activities experience
- Assist in creating and revising microbiological Standard Operating Procedures (SOPs) and other current Good Manufacturing Practices (cGMP) documentation
- Use KM tools for effective Information search and on-going improvement in ways of working
- EM collection experience using particle counters and SAS units, RODAC’s and settling plates
- Supports Microbiologist and Senior Microbiologists with HC and DFDS validation execution and testing
2
Experience For Microbiology Analyst Limerick Resume
- Experience in Endotoxin, Bioburden, ID, Environmental Monitoring is essential
- One (1) year of working experience in a Microbiology Laboratory of a Pharmaceutical Industry
- Knowledge of current Good Manufacturing Practices (cGMPs) within the regulated industry is required
- Knowledge and hands-on experience performing microbiological assays such as Bioburden and Endotoxin
- Strong proficiency with word processing and spreadsheet software
- Associate of Science preferably in Biochemistry, Chemistry, Biology or related field with four (4) years of relevant experience
- AND 1 year of experience in GMP environment
3
Experience For Microbiology Analyst Tues-sat AM Resume
- Responsible for the collection of HC in-process, environmental monitoring, and finished goods samples for analysis
- Participate in microbiological validations as needed for drug substance, in-process controls, buffers and clean utilities qualification program
- Conducts laboratory investigations and generates reports in response to invalid assays, Deviations, OOS/OOT
- Experience in a pharmaceutical / healthcare laboratory or related technical function
- Execute microbiological method transfer / validation
- Execution of method validation/suitability
- Ensures good documentation practices are followed
4
Experience For QC Senior Microbiology Analyst Resume
- Execute microbiological method transfer / validation
- Strong quality and customer focus and pro-active issue resolution
- Good Microbiology knowledge
- GMP / GLP experience
- Quality Control experience in a cGMP organization
- Experience with EM and Water collection
5
Experience For Microbiology Analyst Resume
- Experience in a contract microbiology laboratory
- Strong proficiency with database (e.g. MS Access, SAP, etc.) software
- Handling samples coming from production to QC
- Conducting Food Microbiology testing on Nestlé products and Raw Materials
- Maintaining work area according to 5S and safety principles
6
Experience For QC Microbiology Analyst Resume
- Taking part in the internal and external audits
- Performing equipment calibration
- Monitoring and control of laboratory supply and critical reagent inventories
- Training of other microbiology analysts where necessary
- Performs environmental monitoring including surface, settling and viable and non-viable particulate air monitoring of aseptic operations and controlled areas
- Perform laboratory microbiology and analytical testing and environmental monitoring sampling and testing of cleanroom facilities
- Share with OQ team in fulfilling investigation requirements in conducting investigational testing and submitting results
- Perform necessary laboratory administrative functions such as filing paperwork, photocopying, reviewing of data, and entering data into computerized LIMS
7
Experience For Microbiology Analyst Limerick Resume
- Assist in scheduling of monitoring procedures with follow-up responsibility to assist with providing test results
- Responsible for maintaining the data trending for environmental monitoring program and the preparation of monthly and quarterly reports for HC and DFDS
- Environmental monitoring, water testing and all associated microbial testing as follows
- Perform microscopic techniques/cell counting, utility sampling, environmental monitoring
- Perform wet chemistry testing, chromatographic testing, spectroscopic testing
- Assists with general laboratory housekeeping, including 5S principles
- Assists in the monitoring consumables inventory and ensuring proper levels are maintained
8
Experience For Microbiology Analyst Tues-sat AM Resume
- Handle required microbiological testing for environmental samples of Lactam and Non Lactam Value Streams of sterile and non-sterile manufacturing areas
- Conduct Gowning qualification of Lactam and Sterile filling area operators
- Perform environmental monitoring and utility testing
- Coordinates and contributes towards generation of Semi-Annual Trending Reports for Process Water, Environmental Monitoring and compressed gasses
- BS required in life sciences including biology, immunology, biochemistry, process engineering or a similar biological science
- Schedules monitoring procedures with follow-up responsibility to provide test results
- Sound aseptic technique and understanding of industry best practices, techniques, equipment, and materials
- Wear personal protective equipment including safety glasses, lab coat, and gloves
- Assist with QC microbiological aspects of cGMP compliance and testing
9
Experience For QC Senior Microbiology Analyst Resume
- Responsible for putting the safety of themselves and their team first in every aspect of their job functions
- Assists in the preparation of media and ensures sufficient qualities are available for testing
- Performs bioburden and endotoxin sample analysis in accordance with standard operating procedures (SOPs)
- Assist manufacturing personnel in the identification of microbiological root cause analysis and provide technical advice as needed
- Perform transactions within LIMS (sample receipt, signing tests & specifications etc.)
- Train staff in all areas related to sample preparation and testing
- Use advanced knowledge of food microbiology to develop new testing methods and processes
- Knowledge of principles, terminology, practices, and instrumentation commonly used in a laboratory setting
10
Experience For Microbiology Analyst Resume
- Familiarity with Food Microbiology testing methods and techniques
- Perform routine testing of environmental samples, microbial analysis of water and compressed gasses, and microbial analysis of product samples
- Conduct environmental enumeration of viable air samples, microbial identification, bioburden analysis, and sterility testing
- Provide support to QC management, routine testing, project management and lab operations
- Perform general laboratory support activities including reagent preparation, equipment maintenance, etc
List of Typical Skills For a Microbiology Analyst Resume
1
Skills For QC Microbiology Analyst Resume
- Reviewing microbiological method transfer/validation protocols and final reports
- Experience in aseptic gowning, aseptic techniques, environmental monitoring of clean rooms would be advantageous
- Proven attention to detail and accuracy in following procedures, documentation and data logging
- Demonstrated adaptability and flexibility to support a growing organisation
- Experience in troubleshooting in equipment and test methods
- Experience generating EM trend reports
- Hands-on work experience in a regulated QC Microbiology laboratory within the biopharmaceutical industry
- Experience with electronic systems such as LIMS, Qumas, eDoc, Trackwise etc., is an advantage
- Experience of microbiology testing including Sterility, endotoxin, mycoplasma and Environmental Monitoring
2
Skills For Microbiology Analyst Limerick Resume
- Provides professional know-how to enhance the knowledge and skill base of the organization
- 3-5 five years’ experience in a GMP, clinical or industrial Microbiology laboratory or equivalent
- Experience in laboratory and environmental microbiology, preferably in pharmaceutical or other regulated industry
- Experience in cGMP practices, USP/NF, EP, JP
- Relevant experience for entry to this level
- Demonstrated ability to interface with Manufacturing, Quality Assurance and Materials Management
3
Skills For Microbiology Analyst Tues-sat AM Resume
- Experience in Quality function preferable in multinational company
- Pharmaceutical documentation practices experience
- Efficiently and independently prioritize, manage and complete multiple projects and tasks in a fast-paced environment
- Work experience in a laboratory environment
- Demonstrated proficiency with standard laboratory equipment
4
Skills For QC Senior Microbiology Analyst Resume
- Experience and knowledge of traditional and rapid Microbiology Methods
- Relevant experience for Advanced Level Position
- Training operators for in-process and finished product sensory analysis
- Focus the entire organization on delivering value for customers, including patients, by understanding and meeting their needs
- Responsible for planning own work, assessing own progress, and adjusting efforts to meet goals
- Perform quality control testing, sterility verification and growth promotion testing of incoming media, identification kits and reagents
- Promote and participate in continued improvement initiatives that impact production and increase efficiency, including developing and adhering to current KPIs
- Successful track record in achieving goals as part of a team within a growing, dynamic environment
- Carry out microbiological sampling and analysis as per the sampling schedule and in accordance to the SOPs and ensure 100% results reliability
5
Skills For Microbiology Analyst Resume
- Uses existing procedures to solve routine or standard problems, and occasionally requires basic problem-solving techniques to define problems
- Assist in implementing and maintaining quality and regulatory requirements (e.g. ISO, FDA, GLP, cGMP, USP, CFR)
- Routine in process and finished product sensory profiling and finished products release
- Isolation (physical and SAP system) for sensory/micro non-conforming finished product
- Develop and participate in inter lab ring scheme programme to guarantee lab accuracy and certification
6
Skills For QC Microbiology Analyst Resume
- Determines a course of action based on guidelines and competence developed by performing structured work assignments
- An understanding of pharmacopoeial and regulatory requirements and industry best practice
- Able to work during nights and/or weekends, when needed
- Familiar with the following laboratory disciplines is highly desired
- Maintain adequate inventory media and materials required for testing, routine laboratory maintenance
- Perform Environmental Monitoring in the field, as needed
- General knowledge of FDA regulations pertaining to CGMP’s
- Perform Microbiological testing to support commercial final drug product release
7
Skills For Microbiology Analyst Limerick Resume
- Execution of commercial testing activities in compliance with KPI and upon pre agreed timelines
- Support aberrant / OOT result investigations related to DP testing
- Perform environmental monitoring as per requirements
- Provide technical oversight on microbiological methods and equipment troubleshooting (Shire LatAm QC labs and contracted labs)
- A level of multi-tasking and initiative to meet customer needs
8
Skills For Microbiology Analyst Tues-sat AM Resume
- Third level qualification in Microbiology
- BS/BA in a scientific/technical discipline
- Adherence to all company safety regulations including operating equipment in adherence to the safety guidelines to ensure all safety requirements for self and those working around the machines are met
- Ensuring that chemical reagents and equipment are well calibrated. Ensure that processes are accurate and checking the performance of measuring systems
- Preparation and certification of reagents for use by operator and third party chemical providers
9
Skills For QC Senior Microbiology Analyst Resume
- Propagation of new yeast cultures from vial to generation zero
- Develop and sustain SPC (statistical process control) for quality analysis
- Train operators on online meters calibration and accuracy check
- A holder of BSc. in food science and technology, Chemistry, Biochemistry, Industrial Chemistry or microbiology
- Diploma IBD (additional advantage)
- Develop analytical methods and generate SOPs
- Experience and ability to execute microbiology assay methodologies including enumeration, gram staining, microbial identification, bioburden and sterility testing
10
Skills For Microbiology Analyst Resume
- Experience working in Microbiology in the pharmaceutical industry, preferably in a Biologics company Strong knowledge and practical experience in aseptic techniques and working in Grade A/B facility
- Entry professional role, contributing in a support capacity by receiving instruction, guidance, and direction from others
- Knowledge of GMP and current FDA & EMEA regulations
- Impact is limited to short-term team performance
- Applies knowledge of standardized rules, procedures, and operations within own area
- Impact is limited to the achievement of short- to medium-term goals
- Contributes to delivery of discipline / department goals through personal effort or through influence over team members
List of Typical Responsibilities For a Microbiology Analyst Resume
1
Responsibilities For QC Microbiology Analyst Resume
- Coordinate the validation of Pharmacy operators and processes: sterile media fills for operator and processes, aseptic gowning and chemical accuracy testing
- Responsible for performing and maintaining calibration schedules for Lab. equipment with coordination with validation department
- Responsible for routine Micro lab, stability and analytical method validation testing of Finished products with coordination of other QC sections
- Validate and implement new laboratory procedures/techniques
- Operate the lab equipment properly
- Provide input support to the progression of test method validation, investigations, technical studies, and method transfer protocols
2
Responsibilities For Microbiology Analyst Limerick Resume
- Develop and maintain excellent communication and collaboration between the Microbiology laboratory and operations
- Participate in the technical transfer / validation of microbiological testing procedures including Mycoplasma, Sterility testing and Endotoxin testing
- Partaking in relevant proficiency schemes
- Being involved in project and investigation work as required by the business
- Perform water testing on non-distilled and distilled water throughout the manufacturing facility as per routine sampling and investigational monitoring
- Update existing or write new testing standards and standard operating procedures
- Responsible for routine testing of raw materials, bulk, finished products, purified water and water for injection related to Micro lab
- PH and conductivity testing
- Perform, microbial identification, bioburden analysis, and sterility testing
3
Responsibilities For Microbiology Analyst Tues-sat AM Resume
- Perform microscopic techniques/cell counting
- Ensures equipment is performing well and coordinates preventative maintenance
- Responsible for the collection of DFDS environmental monitoring samples for analysis
- Applicable lab standard operating procedures
- Third level qualification in Microbiology desirable, would consider third level qualification in Pharmaceutical Science
- Enters a Laboratory Cleanroom to collect and log samples for microbial analysis
- Performs or supports the sample analysis for microbial identification
4
Responsibilities For QC Senior Microbiology Analyst Resume
- Autoclaves microbiological media and laboratory waste as needed
- Completes own test records on time and peer reviews data from other analysts for accuracy and completeness
- Assist in the design and set-up of the QC microbiology laboratory and selection/ implementation and calibration of laboratory instruments
- Maintains laboratory reagents, media and supplies
- Writes new and updates current SOPs as needed
5
Responsibilities For Microbiology Analyst Resume
- Presents analytical data reports clearly and concisely to management
- Writes and reviews laboratory SOP’s as directed by company policy
- A third level qualification in a scientific/technical discipline required
- Execute and perform testing as per methods independently, following the company’s Standard Operating Procedures, Deviations and Change Control programs and cGMP guidelines
- Ensure that work order documentation is complete in every respect and all results are entered into Electronic Laboratory Information System or client’s Certificate of Analysis before submission to the QA reviewer
- Perform microbiological testing for product release
6
Responsibilities For QC Microbiology Analyst Resume
- Maintain the state of readiness in the microbiological lab
- Execute testing and Assist the Microbiology Supervisor to meet quality specifications and standards, review test results and have appropriate action strategies in place for non-conformances to ensure GMP and GLP requirements are met
- Perform and be proficient in all testing in the wet and dry areas of the Manufacturing facility and Pharmacy Services. This includes pre sterilisation bioburden testing of product, raw materials, microbial identifications and microbial ingress testing
- Environmental monitoring throughout Baxter operations. Enumerate and trend environmental monitoring from Class A, B, C and D environments. Monitor and review test results and have appropriate action strategies in place for non-conformances to ensure GMP within clean room areas
- Assist in developing and recommending inspection and sampling techniques, quality control plans, testing and analysis procedures to ensure GMP quality specifications and standards are met for QA microbiology functions in Manufacturing and Pharmacy Services
- Maintain close liaison with Manufacturing, Pharmacy Services and QA staff to communicate test results and to assist in adherence to standards and process control
- Perform various microbiological testing procedures as per Manufacturing/Quality Control batch records, stability protocols, raw material requests for testing, etc
- Perform technical review of data generated in laboratory, validation protocols and reports. And technical support to Manufacturing and Projects
- Ensuring laboratory equipment is calibrated and maintained to be fit for purpose
7
Responsibilities For Microbiology Analyst Limerick Resume
- Order, stock and receive laboratory supplies. Provide lab support including reagent preparation, cleaning, and routine equipment maintenance
- New method implementation keeping process efficiency in mind
- Investigate and suggest new laboratory procedures/techniques
- Train Microbiologist I & II in methods and techniques
- Write and review monthly reports as necessary
- Participate in and attend professional seminars, conferences and conventions
- Adherence to the ISO 17025 based Quality Management System procedures
- Represent QC department in internal and external audits where appropriate and close out of actions/ recommendations identified from both internal and external audits
8
Responsibilities For Microbiology Analyst Tues-sat AM Resume
- Investigate out of specification/limit results utilizing Structured Problem Solving, Root Cause Analysis tools in conjunction with the Laboratory Supervisor, QA and other relevant departments and to implement effective corrective and preventative actions while ensuring all investigations are closed with the specified lead-time
- Ensure training is current for all job functions performed
- Receive and manage samples that come into the lab for testing
- Responsible for conducting and documenting the qualification/validation microbiological testing for system, equipment and process testing regarding Sterility testing suite, Lactam and Non lactam Value streams of sterile and non sterile manufacturing areas
- Ensure that the cGMP and safety requirements are fulfilled during work
- Responsible for implementation of all EHS requirements during performance of lab. activities
- Timely facilitation of incoming sample receipt
9
Responsibilities For QC Senior Microbiology Analyst Resume
- Record the results in the relevant lab. documents and quality systems
- Prepare monthly and annual trend reports for viable environmental and water system's results
- Execute microbiological and/or analytical methods to facilitate in-process testing and final release testing such as Endotoxin, Mycoplasma, and Sterility supporting the release of Alofisel biologics product
- Perform environmental monitoring sampling and testing of facilities, equipment, and critical utilities supporting the manufacture of Alofisel biologics product
- Oversee aseptic practices (gowning, monitoring, cleaning and related training)
- Perform growth promotion of media and microbial identification testing
- Compilation and verification of trend analysis reports
- Exhibit proactive communication upon occurrence of compliance risks and deviations from laboratory procedures; perform initiation of investigation records within required timeframes
- Ensure that testing schedules are achieved and manage laboratory resources (instruments and personnel) to provide a comprehensive analytical service for testing of all samples
10
Responsibilities For Microbiology Analyst Resume
- Participate in root cause analyses (RCA) as part of investigations into any non-conformance, instrument malfunction, accident or other abnormal occurrence
- Ensure that any Out of Specification (OOS) or Out of Trend (OOT) analytical results are managed as per SOP
- Prepare and review documents as required
- Prepare for, and support, internal and external audits (e.g. HPRA, FDA, corporate)
- Actively support projects, quality initiatives and continuous improvement programmes within the Quality department and in other functional areas
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