Quality Control Microbiologist Job Description

Quality Control Microbiologist Job Description

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Quality control microbiologist provides training and instruction in safety procedures, ISO 9001:2008 standards, and current good manufacturing practices and LIMS.

Quality Control Microbiologist Duties & Responsibilities

To write an effective quality control microbiologist job description, begin by listing detailed duties, responsibilities and expectations. We have included quality control microbiologist job description templates that you can modify and use.

Sample responsibilities for this position include:

Trains, coaches or mentors on technical issues
Maintain historical files on organisms found in classified areas
Performs all product and raw material test methods utilized in the micro lab
Utilizes and understands internal testing specifications for finished products and raw materials
Performs additional identification tests as necessary (coagulase, oxidase)
Growth within the department is dependent on achievement of thorough knowledge of microbiological method principles, technical writing skills, ability to work independently and train others and troubleshooting for microbiological causes of manufacturing failures, as directed by detailed step-up card
Conduct QC Micro laboratory testing (Sterility, Endotoxin and Gramstain)
Handle sample receipt, retain storage and disposal
Perform environmental monitoring program for Kite
Manage Aseptic gowning training and qualification program

Quality Control Microbiologist Qualifications

Qualifications for a job description may include education, certification, and experience.

Education for Quality Control Microbiologist

Typically a job would require a certain level of education.

Employers hiring for the quality control microbiologist job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and High School Degree in Microbiology, Biology, Science, Chemistry, Pharmacy, Biotechnology, Manufacturing, Biochemistry, Education, Associates

Skills for Quality Control Microbiologist

Desired skills for quality control microbiologist include:

FDA cGMPs
ISO 9001
13485 and 17025
Aseptic techniques
Environment monitoring methods
Gram staining and microbiological test methods
Personal computer skills are
Data processing and good manufacturing practices is desirable
Statistics
Current Good Manufacturing Practices

Desired experience for quality control microbiologist includes:

Be willing to wear eye protection, ear protection, and safety shoes
A minimum of 5 years experience in a GMP pharmaceutical microbiology laboratory with at least 1-year hands on sterility testing using an isolator
Master's degree in Microbiology or Biology or other scientific disciplines with equivalent experience/training
Must be an excellent communicator with the ability to provide recommendations regarding procedures and policies
Have the ability to work on a rotating, five shift schedule, including weekends
Have 2+ years experience in pharmaceutical industry or related field

Quality Control Microbiologist Examples

1

Quality Control Microbiologist Job Description

Job Description Example
Our company is growing rapidly and is looking to fill the role of quality control microbiologist. 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 quality control microbiologist
  • SME on investigations of Microbiological assays and environmental excursions
  • Assemble reports on findings from environmental monitoring of Kite’s cGMP facility
  • Complete routine record review of test data and related documents for in-process testing, drug substance and drug product release
  • Conduct investigations regarding out of specifications (OOS) results, address and manage deviations related to micro procedures
  • Develop, revise and review SOPs
  • Review laboratory data
  • Assist in training staff on methods
  • Train staff on technical concepts and methods
  • Perform assigned Standard Operating Procedures on product/material samples under development
  • Recognizes malfunctions in laboratory equipment and either notifies supervision or performs simple repairs
Qualifications for quality control microbiologist
  • Bachelor's degree or advanced degree in Microbiology or related discipline
  • Six to 8 years’ experience working in a GMP QC Microbiology laboratory, preferably in an aseptic processing facility
  • The incumbent will need to have the ability to gown for entry into Aseptic core and supporting areas, and lift approximately 25 lbs
  • The ideal candidate is well versed in various microbiological techniques including rapid release methods (Bac-T, PTS, MCS), and qualifying environmental monitoring processes with reference to cell therapy product
  • Strong knowledge of Environmental Monitoring requirements and tests (viable and non-viable), Aseptic Process Validation, Microbial Identification, and other applicable methods to the testing of biopharmaceuticals
  • Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211/1271, ISO 14644-1, USP, EP)
2

Quality Control Microbiologist Job Description

Job Description Example
Our company is growing rapidly and is looking to fill the role of quality control microbiologist. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for quality control microbiologist
  • Lead the daily activities of the micro team, ensuring effective use of resources to meet customer service requirements
  • Ownership for the customer service, quality and cost within the micro lab
  • Train personnel in the application of proper micro techniques, use of instrumentation, software applications, methods/procedures, and maintain training
  • Maintain micro laboratory and equipment
  • Delegate tasks to the micro team and ensure completion
  • Perform data review and approval of testing results
  • Perform micro investigation on non-conforming results following site SOPs
  • Author review OOT/OOS reports
  • Interpret data trends and escalate OOT/OOS to leadership effectively
  • Gather and review historical data to support chain risk analysis
Qualifications for quality control microbiologist
  • Strong knowledge of aseptic manufacturing and EM processes
  • Bachelor’s degree in Microbiology preferred with a minimum of 4 years of Microbiology and Environmental Monitoring experience
  • A minimum of 8 years’ experience working in a GMP QC Microbiology laboratory, preferably in an aseptic processing facility
  • Strong knowledge of Environmental Monitoring equipment, requirements and tests (viable and non-viable), Aseptic Process Validation, Microbial Identification, and other applicable methods to the testing of biopharmaceuticals
  • Recent college graduate with experience in a Quality Control lab
  • Possess experience and knowledge of microbiological techniques/methods such as aseptic technique, media selection, preparation, and growth promotion, total viable count, gram stain, and identification
3

Quality Control Microbiologist Job Description

Job Description Example
Our company is growing rapidly and is hiring for a quality control microbiologist. 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 quality control microbiologist
  • Understand and follow health and safety systems and ensure that work is performed using safe working practices
  • Author and review technical documents and procedures
  • Review and approval of technical documents, including specifications
  • Initiate change management actions and deviations using site Quality Management System
  • Testing, review, consultation on micro related issues with the site R&D team
  • Oversee site environmental monitoring (EM) schedule, sampling, testing and reporting
  • Provide monthly and quarterly reports on micro related testing
  • Provide microbiological expertise on other site projects within operations and engineering/technical
  • Strong written and verbal communications to leadership, co-workers and vendors
  • Ensure audit readiness and be the lead subject matter expert for audit activities relating to microbiology
Qualifications for quality control microbiologist
  • Understand basic principles for clean design of equipment and facilities and procedures/requirements for cleaning and sanitization
  • Interpret microbiological method procedures and safety instructions using standard microbiological terms and measures
  • Perform routine calculations pertaining to general laboratory practices and microbiological techniques
  • Ability to develop and implement laboratory procedures relating to technical expertise, quality, and safety
  • Have the ability to work on a rotating shift schedule including weekends
  • Must have training and experience to work safely around laboratory equipment, biohazardous substances (BSL-1/BSL-2), and/or hazardous chemicals in manner that complies with safety and quality standards
4

Quality Control Microbiologist Job Description

Job Description Example
Our innovative and growing company is looking to fill the role of quality control microbiologist. 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 quality control microbiologist
  • Method qualifications
  • May perform basic microbial identification
  • May perform acceptance testing of commercially prepared microbiological culture media
  • Carry out microbiology analysis including Total Viable Count (TVC), sterility and Endotoxin testing as required
  • Carry out environmental monitoring including Viable/non-viable particles monitoring in manufacturing facilities
  • Carry out analytical testing including pH, Conductivity, Total Organic Carbon (TOC) and chemistry testing as required
  • Participate in the technical transfer / validation of microbiological and analytical testing procedures
  • Ensure that all cGMP, company specifications, procedures and guidelines are followed
  • Investigate Out of Specification (OOS) and Out of Trend (OOT) results as required
  • Investigate Non Conformances and actively lead subsequent corrective actions as required
Qualifications for quality control microbiologist
  • Bachelor’s degree in Microbiology, Chemistry, Biology, or Pharmacy
  • Assigned within the Microbiology area and/or previous experience in microbiology processes is preferred
  • Lead the QC Microbiology team through daily functions to support manufacturing to ensure on time release of product
  • Act as a consultant on all microbiological issues relating to the site processes and products
  • Take front-line responsibility for the microbiology laboratory to ensure efficient operation
  • Coordinate environmental monitoring sampling and trending of results
5

Quality Control Microbiologist Job Description

Job Description Example
Our company is hiring for a quality control microbiologist. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for quality control microbiologist
  • Participate in and responsible for QC related CAPA’s
  • Adhere to QC documentation system and prepare and review document change requests as required
  • Develop, improve and implement QC procedures, processes and systems
  • Support projects and continuous improvement initiatives within the Quality department and other functional areas
  • Participate in international project teams relating to QC and wider quality activities and travel maybe required
  • Adhere to safety standards to ensure a safe working environment while ensuring the laboratory is kept clean, tidy and safe at all times
  • Prepare for, and support regulatory and internal inspections/audits
  • Provide hands-on guidance and training when needed
  • Maintain current knowledge of regulatory and industry standards, trends and advancements through independent reading and training
  • You will carry out Quality Control Testing in accordance with Oxoid test specifications and methods
Qualifications for quality control microbiologist
  • Quality Control, GMPs, microbiological method development and validation
  • Support new installation for hygienic design
  • Show passion for quality by taking responsibility and ownership for compliant processes
  • Ability to be flexible with schedule, and work overtime
  • Associates Degree in Life Sciences or equivalent or a High School diploma with relevant experience, preferably in the pharmaceutical or biotechnology industries
  • Knowledge of current microbiological techniques

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