The Microbiology Technician also known as Microbiology Laboratory Technician or Quality Control Microbiology Technician supports product quality and regulatory compliance by performing routine and nonroutine microbiological testing of raw materials in process samples and finished products. This role focuses on environmental monitoring water system testing preservative efficacy testing and accurate laboratory documentation in accordance with USP cGMP and regulatory requirements. The position plays a key role in maintaining microbiological integrity data accuracy and laboratory compliance within a regulated life sciences environment.
Responsibilities:
-
Perform routine and nonroutine microbiological analyses following approved SOPs USP methods and compendial standards.
-
Conduct environmental monitoring of manufacturing areas equipment and utilities including air surface and personnel monitoring.
-
Sample and test water systems performing microbiological pH and conductivity analyses.
-
Prepare media reagents and test organisms and perform pour plate testing aseptic techniques and preservative efficacy testing.
-
Accurately document laboratory data results and activities in controlled records and laboratory notebooks in compliance with cGMP.
-
Participate in investigations of out of specification or atypical microbiological results and support root cause analysis.
-
Execute system suitability testing and verify equipment performance according to USP and internal procedures.
-
Maintain laboratory cleanliness inventory of supplies and proper handling and disposal of biohazardous and chemical waste.
-
Collaborate with cross functional teams to support production quality and development objectives while meeting assigned timelines.
Qualifications:
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Bachelors degree in Microbiology Biology or a related life sciences discipline.
-
Knowledge of microbiological laboratory techniques equipment operation and biohazard safety practices.
-
Hands on experience with aseptic technique media preparation pour plating and routine microbiological testing.
-
Familiarity with USP test organisms and maintenance of microbial cultures.
-
Understanding of cGMP documentation practices data integrity and laboratory record keeping.
-
Strong technical writing verbal communication and interpersonal skills.
-
High attention to detail strong organizational skills and ability to manage multiple priorities.
-
Proficiency with computers and standard office software applications.
-
Ability to work independently in a fast paced regulated laboratory environment.
-
Ability to read write and communicate effectively in English.
Desired Qualifications:
-
One to two years of experience in a quality control microbiology or manufacturing laboratory environment.
-
Knowledge of regulatory standards such as FDA regulations ISO quality systems and cGMP guidelines.
-
Familiarity with 21 CFR Part 11 Part 210 and Part 211 requirements.
-
Experience supporting laboratory investigations method troubleshooting or continuous improvement activities.
-
Prior exposure to environmental monitoring programs and water system validation testing.
The Microbiology Technician also known as Microbiology Laboratory Technician or Quality Control Microbiology Technician supports product quality and regulatory compliance by performing routine and nonroutine microbiological testing of raw materials in process samples and finished products. This role...
The Microbiology Technician also known as Microbiology Laboratory Technician or Quality Control Microbiology Technician supports product quality and regulatory compliance by performing routine and nonroutine microbiological testing of raw materials in process samples and finished products. This role focuses on environmental monitoring water system testing preservative efficacy testing and accurate laboratory documentation in accordance with USP cGMP and regulatory requirements. The position plays a key role in maintaining microbiological integrity data accuracy and laboratory compliance within a regulated life sciences environment.
Responsibilities:
-
Perform routine and nonroutine microbiological analyses following approved SOPs USP methods and compendial standards.
-
Conduct environmental monitoring of manufacturing areas equipment and utilities including air surface and personnel monitoring.
-
Sample and test water systems performing microbiological pH and conductivity analyses.
-
Prepare media reagents and test organisms and perform pour plate testing aseptic techniques and preservative efficacy testing.
-
Accurately document laboratory data results and activities in controlled records and laboratory notebooks in compliance with cGMP.
-
Participate in investigations of out of specification or atypical microbiological results and support root cause analysis.
-
Execute system suitability testing and verify equipment performance according to USP and internal procedures.
-
Maintain laboratory cleanliness inventory of supplies and proper handling and disposal of biohazardous and chemical waste.
-
Collaborate with cross functional teams to support production quality and development objectives while meeting assigned timelines.
Qualifications:
-
Bachelors degree in Microbiology Biology or a related life sciences discipline.
-
Knowledge of microbiological laboratory techniques equipment operation and biohazard safety practices.
-
Hands on experience with aseptic technique media preparation pour plating and routine microbiological testing.
-
Familiarity with USP test organisms and maintenance of microbial cultures.
-
Understanding of cGMP documentation practices data integrity and laboratory record keeping.
-
Strong technical writing verbal communication and interpersonal skills.
-
High attention to detail strong organizational skills and ability to manage multiple priorities.
-
Proficiency with computers and standard office software applications.
-
Ability to work independently in a fast paced regulated laboratory environment.
-
Ability to read write and communicate effectively in English.
Desired Qualifications:
-
One to two years of experience in a quality control microbiology or manufacturing laboratory environment.
-
Knowledge of regulatory standards such as FDA regulations ISO quality systems and cGMP guidelines.
-
Familiarity with 21 CFR Part 11 Part 210 and Part 211 requirements.
-
Experience supporting laboratory investigations method troubleshooting or continuous improvement activities.
-
Prior exposure to environmental monitoring programs and water system validation testing.
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