Microbiology Analyst Resume Samples

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C Nader

Christophe

Nader

95418 Gabrielle Trail

Chicago

+1 (555) 724 5575

95418 Gabrielle Trail

Chicago

Phone

p +1 (555) 724 5575

Experience Experience

Boston, MA

Microbiology Analyst

Boston, MA

Hane-Bailey

Boston, MA

Microbiology Analyst

Interpreting sampling and monitoring data, applies statistical and analysis techniques, to determine control and trending
Assist Group Leader/Manager to trouble-shoot test methods/instruments
Assist Group Leader/Manager to prepare method SOP, validation protocol and validation report, and perform validation experiments
Performs sterility release review
Works well under pressure
Participate in the validation of methods and review of controlled documents in accordance with established timescales
Perform all activities in compliance with relevant GMP and Quality Systems standards and specifically with FDA Quality System Regulation and ISO 13485

Dallas, TX

QC Microbiology Analyst

Dallas, TX

Hessel, Keeling and Breitenberg

Dallas, TX

QC Microbiology Analyst

Providing training to other analysts and to manufacturing personnel
Performing any other activities as indicated by the Microbiology Supervisor
Assisting with out of specification investigations
Performing a wide variety of microbiology, chemistry or biochemistry testing to support utilities, raw material, in process, bulk and drug product release
Proactively identifies and implements lab process improvements
Providing support and advice to manufacturing on QC related topics
Proactively identifies and implements lab process improvements, lean initiatives

present

Boston, MA

Microbiology Analyst Tues-sat AM

Boston, MA

Conroy-Welch

present

Boston, MA

Microbiology Analyst Tues-sat AM

present

Documentation and data entry of final results into the Laboratory Information Management System (LIMS)
Daily, monthly, and quarterly cleaning and sanitizing of assigned laboratory areas
Pathogen detection using cultural, ELISA, and PCR methods
Bacterial enumeration using pour plate, spread plate, Petrifilm, and MPN methods
Compositing of finished product and raw material samples
Allergen testing
Bacterial identification via Vitek

Education Education

Bachelor’s Degree in Microbiology

Loyola University Chicago

Bachelor’s Degree in Microbiology

Skills Skills

Proven ability to manage and coordinate multiple projects in a fast-paced, highly professional environment
Proven time management skills and a strong attention to detail
Knowledge of techniques in a microbiology discipline, e.g
Ability to work well with others & independently
Ability to understand assay methods
Ability to perform routine bench and instrumental analysis
Documentation and data entry of final results into the Laboratory Information Management System (LIMS)
Bacterial identification via Vitek
Allergen testing
Pathogen detection using cultural, ELISA, and PCR methods

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15 Microbiology Analyst resume templates

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QC Microbiology Analyst Resume Examples & Samples

Performing a wide variety of microbiology, chemistry or biochemistry testing to support utilities, raw material, in process, bulk and drug product release
Performing data review and approval
Providing support and advice to manufacturing on QC related topics
Initiating and leading investigations where required
Initiates and completes, CAPAs and Change Controls in accordance with site procedure
Writes new and updates current procedures on electronic documentation system
Providing training to other analysts and to manufacturing personnel
Presents technical analytical data clearly and concisely data to customers, i.e., internal investigations and regulatory inspectors etc
Proactively identifies and implements lab process improvements
Supports lean initiatives in the area of lab operations, i.e. standard work, level loading, test method execution, documentation updates and equipment qualification etc
Supports Team leader on day to day testing operations

Microbiology Analyst Resume Examples & Samples

Third level qualification in Food Science, Microbiology, Biotechnology or equivalent
3-5 years' microbiological laboratory experience within the food industry, environmental analysis an advantage
Knowledge of laboratory and quality control release procedures within the food industry
Strong documentation skills required
Computer Skills essential, Microsoft Office, SAP, LIMs etc
Experience in a 3rd party contracting lab would be an advantage

Microbiology Analyst Resume Examples & Samples

Perform microbiological testing on raw materials, components and finished products
Perform microbiological testing as required for stability and development purposes to support the R& D laboratories
Develop and validate methods as per the appropriate requirements
Calibration and maintenance of laboratory equipment
Reporting and checking of test details and results using worksheets, laboratory notebooks and /or spreadsheets as required
Preparing protocols, reports and test methods
Maintaining cGMP and cGLP at all times
Writing and reviewing all relevant SOP's

Microbiology Analyst Resume Examples & Samples

Collecting the samples on production lines
Doing the appropriate analysis (biochemical & microbiological)
Participate to the coaching of hourly employees in production
Has a diploma of college studies (DCS) in Process technology and the quality of foods, food transformation technical, microbiology, biology, biotechnology
Has a work experience in a Manufacturing Food Industry
Is familiar with the methods and software used in a laboratory
Is fluent in French, orally and written

Microbiology Analyst Resume Examples & Samples

Environmental monitoring of cleanrooms for viable air, viable surface and particulate in line with ISO 14644 standards
Monitoring of utilities including all grades of water, and where necessary, compressed air
Co-ordination of samples for bioburden and endotoxin testing
Ordering consumables (media etc) and general stock for day-to-day running of laboratory
Applying cGLP to all laboratory activities including stock control
Performing sampling for validations and re-qualifications as required
Interpreting sampling and monitoring data, applies statistical and analysis techniques, to determine control and trending
Input to NC and CAPA generation and resolution within the Microbiology group and across related business units. Competency into correction of NCs
Performs sterility release review
Proficient in local procedures and practices
Bachelor degree of Microbiology or equivalent
Experience in a Quality/Regulatory Affairs environment desirable
Ability to build knowledge and understanding of US and International Medical Device Regulations and standards in area of expertise (Microbiology)
Minimum 2 years' experience in a similar environment

Microbiology Analyst Resume Examples & Samples

With guidance, leads small scope projects. Schedules and coordinates project activities
Provide support in performing Microbiology studies under the guidance of industrialization manager or senior scientist
Lead or provide support to perform raw material characterization and qualification including chemicals or biological such as Peptones, extracts…
Writes validation protocols and conducts validation activities as required by the change control program
Manage microbiological studies in the lab including Environmental monitoring investigation, equipment cleaning verification, culture media formulation studies and growth performances testing, kinetic studies, bio burden testing, contaminant identification using classical ID panels or Mass Spectrometry…
Conducts Failure Investigations and implements solutions (corrective and preventive actions) that solve manufacturing and product problems, follow-up on corrective and preventive actions to determine their effectiveness and suitability, and prepare written reports on these activities in a timely fashion
With supervision , design, review and revise Manufacturing and Quality Control documents for new and existing products and processes
Support our process chemists by running some analytical experimentation including pH, conductivity, HPLC, FTIR, UV-VIS or any analytical equipment
With supervision, interface with existing vendors, and identify and qualify new vendors, to assure delivery of quality raw materials and components at reasonable costs
BS or MS degree ideally in Microbiology with experience or equivalent knowledge and skills to perform the position’s responsibilities or equivalent
Good project leadership and oral and written communication skills are required
3-5 five years’ experience in a GMP, clinical or industrial Microbiology laboratory or equivalent
Proficiency with microbiological culture techniques and assays is required
Demonstrated excellent interpersonal skills are required

QC Microbiology Analyst Resume Examples & Samples

Environmental and Facilities monitoring sampling and testing
Validation/Qualification of Microbiology test methods and test systems such as the Endotoxin test system and Identification system
Represent the Microbiology department in internal and external audits where appropriate
Assist in ensuring that current compliance issues and trends, both internal and site-wide, are critically evaluated and training is provided where appropriate. To maintain competence and keep up to date with all new technologies, procedures and methods used in the Microbiology Laboratory. . Perform technical review of data generated in laboratory, validation protocols and reports. Provide Technical support to Manufacturing and Projects which the company undertakes through project participation, investigation, validation and testing activities and prepare Technical Reports as required. To ensure all instruments/equipment are maintained in a calibrated and operational state. To travel and represent the organization as may be required for technical knowledge and ability. To ensure a high standard of housekeeping and safety is maintained in the Laboratory
Completion of project work and implementation of initiatives designed to improve the efficiency of the laboratory function/department
To report to and be directed by the Laboratory Management and to organize and schedule the smooth running of the laboratory in the absence of the Laboratory Manager
To keep management updated on issues arising within the laboratory
Investigate out of specification/limit results utilizing Structured Problem Solving, Root Cause Analysis tools in conjunction with the Microbiology 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
To train laboratory personnel and play appropriate role in the development, operation and evaluation of training/re-training programs
Technical competency in Sterility Assurance, Aseptic filling and microbiology methods
Problem solving and root cause analysis skills
Planning/scheduling of own work and subordinates and ability to delegate tasks where appropriate
LI-CH1

QC Microbiology Analyst Resume Examples & Samples

Experience in testing of sterile drug product and aseptic filling process of pharmaceutical /biopharmaceutical products
Experience in Method Validation
Good knowledge of current regulatory requirements for Microbiology / Sterility Assurance in support of cGMP operations supporting clinical and commercial manufacturing
Experience in Quality Risk Management

Microbiology Analyst Resume Examples & Samples

Perform routine microbiological test procedures including environmental monitoring and product testing as part of a testing service to QA Operations and Production as and when required. Approval and sign off of test results
Take responsibility for the co-ordination and conduct of environmental monitoring and cleaning validation for medical device or pharmaceutical manufacturing areas, especially in support of change control projects. Ensure that protocols and reports are generated to provide regulatory compliant quality records
Initiate deviations and carry out investigations for deviations / non-conformance. Ensure that these are followed through and information is passed on for reporting and completion in a timely manner
Collate finished product bioburden and environmental test data to prepare summary reports of trends, for feedback to production management and operators or for use during internal and external audits
Participate in the validation of methods and review of controlled documents in accordance with established timescales
Take part in cross-functional teams within QA to ensure that the laboratory is represented and contributes positively to continuous improvements to procedures in Microbiology and QA
Take part in day to day housekeeping, general section duties and any other non-designated work activities as and when the needs of the section requires it, to ensure that the work place promotes a professional image
Perform all activities in compliance with relevant GMP and Quality Systems standards and specifically with FDA Quality System Regulation and ISO 13485
Apply high standards of occupational Health & Safety in the workplace to comply with company policy and procedures
A degree in a biological science or experience as a laboratory technician with a BTEC or equivalent in a science subject
Ability to work with less direct supervision
Ability to interpret results and instigate the resolution of any problems

QC Senior Microbiology Analyst Resume Examples & Samples

Performing QC Environmental Monitoring in Cleanrooms, Utility Sampling (Including WFI, Clean Steam and Compressed Gas), associated testing of the samples and completion in a timely and accurate manner of laboratory documentation as directed by the Microbiology Supervisor
Provide support to other departments to ensure qualification and production schedules are adhered to
Ability to Work on own initiative with minimum supervision, and as part of a team
Compliance with Standard Operating Procedures and Registered Specifications
Assisting in authoring and reviewing documentation, including trend reports, SOPs and training materials as required
Batch paperwork and Data review, and reconciliation of analysis performed in laboratory. Ensuring that any out of specification results are investigated according to site procedures
Training of Laboratory personnel
To ensure a high standard of housekeeping and safety is maintained in the laboratory
Previous experience in qualification of Cleanrooms and Utility systems is desirable but not a requirement
Minimum of a third level qualification (Degree) in Microbiology or related discipline
At least 2/3 years of experience in a pharmaceutical / healthcare laboratory or related technical function
A strong background in Microbiology and aseptic manufacturing is required

QC Microbiology Analyst Resume Examples & Samples

Performing QC Environmental Monitoring (Including Clean Utilities), associated testing of the samples and completion in a timely and accurate manner of laboratory documentation as directed by the Microbiology Supervisor
Assisting in authoring and reviewing documentation, including SOPs, as required
Keeps abreast of current corporate and industry requirements and compliance trends as they pertain to laboratory operations and aseptic manufacturing
Batch paperwork review, and reconciliation of analysis performed in laboratory. Ensuring that any out of specification results are investigated according to site procedures
Assisting with out of specification investigations
Performing any other activities as indicated by the Microbiology Supervisor
The ideal candidate should hold a minimum of a Level 8 degree in Microbiology or related discipline
At least 1 years’ experience in a pharmaceutical / healthcare laboratory or related technical function
A strong background in Microbiology and aseptic manufacturing is desirable
The successful candidate must demonstrate excellent written and verbal communication skills
The ability to work in a team based collaborative environment is essential

QC Microbiology Analyst Resume Examples & Samples

Requires a Bachelor’s degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) in a scientific discipline or four (4) years of experience in lieu of a degree
A minimum of 2 years of responsible job related experience
Working knowledge of current Good Manufacturing Practices (cGMPs) and scientific principles
Ability to follow SOPs and comply with cGMPs
Ability to develop analytical methods and generate SOPs
Perform a variety of analyses including computer-based instrumental analytical methods
Working knowledge of a laboratory environment and equipment used for pharmaceutical analysis
Experience working in a pharmaceutical testing environment
Experience and ability to execute microbiology assay methodologies including enumeration, gram staining, microbial identification, microbial limits and the ability to subculture
Good technical writing skills
Must be able to obtain and maintain a security clearance
General knowledge of Biosafety Level 2 (BL2)
Analytical equipment qualification
Use of electronic systems
Experience and knowledge of traditional and Rapid Microbial ID Methods
Experience with genotyping of microorganisms
Ability to interface with Manufacturing, Quality Assurance, Materials Management

Microbiology Analyst Resume Examples & Samples

Maintains working knowledge of instrumentation, equipment, and scientific methodologies necessary to perform assigned task
Performs assigned tasks carefully and on schedule according to standard operating procedure and supervisors instructions
Isolates and makes cultures of bacteria or other microorganisms in prescribed media, controlling moisture, aeration, temperature, and nutrition
Performs tests on water, test articles and the environment to detect harmful microorganisms and to obtain information on types and levels of microbial contamination
Examines physiological, morphological, and cultural characteristics, using microscope and other relevant equipment, to identify and classify microorganisms in test articles
Studies impact of microorganisms on products and evaluate impact of microbial control strategies on microorganism survival
Keeps proper documentation of work performed
Maintains accurate records
Participates in company training and maintain current status of certifications as applicable
Complies with applicable GMPs
Provides technical training and leadership for subordinate technical positions
Maintains a safe, clean, and organized work environment free from safety hazards
Punctual with low absenteeism and works the hours necessary to meet scheduling commitments
Maintains productive work ethic

Microbiology Analyst Resume Examples & Samples

Perform additional cleanroom testing activities including but not limited to
HEPA Filter Leak Testing
Biological Safety Cabinet Testing
Gain familiarity and adhere to requirements as documented in Standard Operating Procedures for Good Manufacturing Practices (GMPs)

QC Microbiology Analyst Resume Examples & Samples

Possess a Bachelor’s degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) in a scientific discipline or four (4) years of relevant experience in lieu of degree
No experience is needed with a Bachelor’s degree
General knowledge of cGMP operations and BL2
Demonstrated ability to interface with Manufacturing, Quality Assurance, Materials Management

Microbiology Analyst Limerick Resume Examples & Samples

Achieves competency in CBIL laboratory methods and procedures
Trains other QC analysts in laboratory methods and procedures when required
Performs Microbiological and/or Chemical testing activities in relation to method validation and technical transfer activities so as to ensure that all methods meet ICH, CFR and USP guidelines.·
Executes testing activities as specified in IQ/OQ and PQ protocols so as to ensure that all relevant equipment is qualified for cGMP use
Performs routine Microbiological and/or Chemical testing activities during Plant production phase
Reviews laboratory test results when required.·
Ensures that testing and results approval are completed within agreed turnaround times.·
Writes and reviews laboratory SOP’s as directed by company policy
Ensures QC activities are carried out in compliance with product licence commitments, cGMP and company quality standards.·
Is an active member of the QC group and provide assistance with other group activities as required and communicates relevant issues to the QC Team Leader. ·
Anticipates and plans for future requirements in the area
Deputises for the QC Team Leader as appropriate
Maintains and develops knowledge of analytical technology as well as cGMP standards

Microbiology Analyst Resume Examples & Samples

Environmental Monitoring sampling
Knowledge of cGMP
Experience working in a laboratory setting
HS Diploma/Associates degree

Microbiology Analyst Resume Examples & Samples

Media preparation and use of autoclaves
Collecting environmental samples
Bacterial enumeration using pour plate, spread plate, Petrifilm, and MPN methods
Bacterial identification via Vitek
Allergen testing

QC Microbiology Analyst Resume Examples & Samples

Performing QC testing of samples for Bioburden and Endotoxin. Completion in a timely and accurate manner of laboratory documentation as directed by the Microbiology Supervisor
Performing growth promotion, culture collection maintenance and identification using rapid Microbiology techniques
The successful candidate must demonstrate excellent written and verbal communication skills and the ability to work in a team based collaborative environment
The ideal candidate should hold a minimum of a third level qualification (Degree) in Microbiology or related discipline along with at least 1 year of experience in a pharmaceutical / healthcare laboratory or related technical function

Microbiology Analyst Resume Examples & Samples

Execute and perform testing as per methods independently, following the company’s Standard Operating Procedures, Deviations and Change Control programs and cGMP guidelines
Keep all records and notebooks in good order. Prepare reports and record data in timely manner
Maintain up to date work order documentation and complete work order documentation in every respect before submission to the Department Manager/Group Leader to ensure valid outcome/results
Conduct routine instrument checks for compliance and accurate testing results. Perform calibrations and qualifications as required. Record accurate findings/usage in log books
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
Maintain clean and organized workbench area ensuring spills are immediately cleaned; disposal is according to laboratory procedures, glassware is appropriately handled and lab solutions are replaced
Assist Group Leader/Manager to prepare method SOP, validation protocol and validation report, and perform validation experiments
Assist Group Leader/Manager to trouble-shoot test methods/instruments
Ensure that equipment is maintained in good order; perform calibrations and qualifications as required
BSc. or Diploma in Microbiology-related fields or equivalent experience or training
Minimum of 1 year of relevant laboratory work experience required or equivalent lab experience through education
Knowledge of techniques in a microbiology discipline, e.g
Ability to perform routine bench and instrumental analysis
Ability to understand assay methods
A willingness to learn new analytical tests, instrumentation and procedures
Candidates must demonstrate excellent verbal and written communication skills including grammar and composition
Proven time management skills and a strong attention to detail

Microbiology Analyst Tues-sat AM Resume Examples & Samples

Daily, monthly, and quarterly cleaning and sanitizing of assigned laboratory areas
Compositing of finished product and raw material samples
Pathogen detection using cultural, ELISA, and PCR methods
Documentation and data entry of final results into the Laboratory Information Management System (LIMS)

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