Microbiology Analyst Job Description
Microbiology analyst
provides QC oversight and approval of cGMP QC documents (change controls, deviations, CAPAs, procedures, validation protocols, etc.).
Microbiology Analyst Duties & Responsibilities
To write an effective microbiology analyst job description, begin by listing detailed duties, responsibilities and expectations. We have included microbiology analyst job description templates that you can modify and use.
Sample responsibilities for this position include:
Reporting of results on LIMS and generation of results report
Verifies and enters approved results in laboratory information management systems (LIMS)
Maintains and develops knowledge of analytical technology cGMP standards
Adhere to all effective STM’s/SOPs and safety requirements and document laboratory work consistent with cGMP requirements
Presents technical analytical data clearly and concisely data to customers, , internal investigations and regulatory inspectors
Supports lean initiatives in the area of lab operations, standard work, level loading, test method execution, documentation updates and equipment qualification
Administration of environmental monitoring program (environmental swabbing such as Salmonella testing)
Execution of environmental monitoring analysis in compliance with cGLP and SOPs, including sample administration, media preparation, sample preparation and result reporting
Providing real time updates on analysis to the Laboratory Manager
Maintain high hygiene standards in the pathogen lab
Microbiology Analyst Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Microbiology Analyst
List any licenses or certifications required by the position: ASCP
Education for Microbiology Analyst
Typically a job would require a certain level of education.
Employers hiring for the microbiology analyst job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Associate Degree in Microbiology, Science, Biology, Chemistry, Associates, Biochemistry, Education, Life Sciences, Technical, Biotechnology
Skills for Microbiology Analyst
Desired skills for microbiology analyst include:
CGMP
CGMPs
GMP and current FDA & EMEA regulations
LIMS
Compliance requirements
GLP and FDA regulations and the ability to interpret and apply them
Laboratory aseptic procedures in a pharmaceutical industry
Air samplers
Biohazards
CGMP QC laboratory environment
Desired experience for microbiology analyst includes:
Providing support to the main micro lab
Maintaining stocks of consumables including ordering of consumables
Input to NC and CAPA generation and resolution within the Microbiology group and across related business units
Participate in compliance audits, investigations, and CAPA implementation
Lead specific aspects of a project, guide solutions for difficult problems, execute project tasks
Performs other duties relevant to the QC laboratory position as required
Microbiology Analyst Examples
1
Microbiology Analyst Job Description
Job Description Example
Our company is searching for experienced candidates for the position of microbiology analyst. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for microbiology analyst
- Performs standardizations of volumetric/titrimetric solutions, and prepares dissolution media and HPLC mobile phase, among other solutions including microbiological solutions
- Prepare media, collect purified water for testing and use the Autoclave for waste disposal
- Running test samples for In-Process, Lot Release and Stability studies
- Basic problem solving of methods troubleshooting of equipment
- Recognize aberrant test and sample conditions and report to them to the area supervisor / manager with an assessment of the circumstances and potential corrective action if appropriate
- Perform various microbiological testing procedures as per manufacturing/Quality Control batch records, stability protocols, raw material requests for testing
- Operation of a biohazard trash autoclave
- Perform daily checks on equipment
- Stock the lab on a daily basis
- Prepare disinfectant solutions, reagents, samples for analyses
Qualifications for microbiology analyst
- Proficient in MS Word, Outlook, and Excel programs PowerPoint, Project and Visio
- Cover shifts as needed
- BS in Microbiology, Biology, or related
- At least 1-2 years of recent industry experience as a Microbiologist adhering to GMPs
- Basic familiarity with major classes of microorganisms
- General computer program operations, inc. Word, Excel, Outlook
2
Microbiology Analyst Job Description
Job Description Example
Our innovative and growing company is looking for a microbiology analyst. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for microbiology analyst
- Perform a broad range of laboratory procedures ranging from routine to complex following written procedures
- Be familiar with a wide variety of analytical/biological/Compendia methodologies and techniques
- Make detailed observations, consistently analyze data, and interpret/review data
- Maintain laboratory records and inventory for supplies and reagents
- Perform preventative and corrective maintenance on complex laboratory equipment in accordance with established procedures
- Maintain a clean and sanitary work area in accordance with standard laboratory practice and procedures
- Contribute to troubleshooting / laboratory investigation efforts with supervisory guidance
- Identify opportunities for improvements within Microbiology procedures and documentation
- Train and provide assistance in basic QC Microbiology tasks to junior staff
- Execute development, method suitability, and validation studies
Qualifications for microbiology analyst
- Use of basic lab equipment and some more complex equipment with assistance
- Execute procedures as written
- Recognize deviations from procedures and need for investigations
- BS or BA degree in biology, microbiology, or related science
- Strong understanding and exemplary compliance to Good Manufacturing Practices
- Ability to read, analyze, interpret, and follow standard operating procedures, professional journals, technical procedures and governmental regulations
3
Microbiology Analyst Job Description
Job Description Example
Our company is looking for a microbiology analyst. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for microbiology analyst
- Prepare Autoclave supplies and garbage when required
- Perform tasks effectively with minimal supervision
- Performs more complex sample preparation & analyses
- Understands analysis procedures and problem solves issues
- Suggests and helps to implement production efficiencies
- Recommends solutions (technical/ staffing), which will make the lab more effective and competitive
- Ensures a high level of accuracy in sample prep and analysis
- Provides input to corrective action procedures
- Actively involved and provides support to ensures that instruments and equipment are maintained
- Identifies and communicates non conformances to Supervisor
Qualifications for microbiology analyst
- A university degree or technical diploma in Microbiology, biology or a related field of study
- Minimum 2 - 4 years of related experience in a recognized professional or technical/scientific field
- Comprehensive knowledge of pharmaceutical GLPs and GMPs
- Knowledge of regulatory guidance
- Knowledge of laboratory techniques and safety precautions
- WHMIS and biohazard safety awareness
4
Microbiology Analyst Job Description
Job Description Example
Our company is looking to fill the role of microbiology analyst. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for microbiology analyst
- Adheres to Maxxam Code of Ethics Policy
- Supports and complies with all Maxxam policies, Quality System and Health & Safety program
- Participates, when requested in lab and health and safety meetings
- Participates, when requested in internal and external audits
- Keeps work area clean, neat and organized
- Provides general lab support to other departments as required
- Performs, coordinates and supports method validations and prepares final reports documenting the validation findings
- Receives and interprets the results of bioburden, microbial limits, environmental monitoring, growth promotion testing and sterility testing
- Will investigate all out-of-limit conditions and with the direct support from the Laboratory Manager implement a corrective action
- Reviews and approves all laboratory testing documentation
Qualifications for microbiology analyst
- Mathematical skills including the ability to analyze scientific and test data, and a basic understanding of statistical
- Lab experience in biotech or medically related field
- A minimum of 3 years previous experience in a QC laboratory-testing environment within the medical devices or pharmaceutical industry
- Competent in laboratory safety and generally-accepted lab practice, including maintaining adequate written laboratory records
- Ability to work in a fast-paced and highly regulated environment
- Able to communicate and articulate information in both written and verbal forms
5
Microbiology Analyst Job Description
Job Description Example
Our company is growing rapidly and is searching for experienced candidates for the position of microbiology analyst. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for microbiology analyst
- Must make sure that all laboratory supplies, inventory and on-going lab operations do not exceed a specified budget
- Insures that the correct and most updated versions of SOP’s are available to all laboratory personnel
- Reviews current regulatory and technical journals to help provide guidance and to support manufacturing regarding microbiological issues
- Takes on any additional tasks as assigned by the Laboratory Supervisor
- Write and/or execute microbiological method qualification and validation according to contemporary quality standard
- Work with Marketing, Program Management, R&D functions and other stakeholders to identify solutions to customer needs and develop concepts for features and products
- Create user stories, acceptance criteria and ensure that stories meet the Definition of Ready
- Critically evaluate information gathered from multiple sources, reconcile conflicts, decompose high-level information into details, abstract up from low-level information to a general understanding, and distinguish user requests from the true underlying needs
- Turn capabilities into features and features into stories
- Work with engineering Scrum team(s) to determine the best method to break down work items
Qualifications for microbiology analyst
- Flexibility to deal with different situations and personalities
- Able to assess problems and recommend solutions
- Post-secondary school education (BSc preferred) or equivalent experience
- Positive outlook with a ability to work in a fast paced environment
- This position has limited supervisory responsibility
- High level of work production in fast paced lab environment