Insight Global is seeking a microbiologist to support a pharmaceutical client in Rahway, NJ. This microbiologist plays a crucial role in ensuring the microbiological integrity of pharmaceutical manufacturing areas and pharmaceutical products. This professional conducts thorough environmental monitoring to uphold regulatory standards in GMP-regulated spaces and should be well versed in EM protocols, investigations, and quality risk assessments. Additionally, qualified candidates should have experience in routine drug product testing. This position is on-site 5 days a week.
Role and Responsibilities:
MICROBIOLOGICAL PRODUCT ANALYSIS
Analyze samples and compile meaningful data
Perform Investigations and prepare/respond to CAPA
Review, revise Test Procedures/Standard Operating Procedures
Ad Hoc work
Rotational on-call assignments
MICROBIOLOGICAL ACTIVITIES Include (but not limited to):
Receive, verify & Log in samples
Return templates and shipping paperwork when and where appropriate
Compile and trend data
Prepare and ship materials offsite for ID/testing (when applicable)
Environmental monitoring
Stock culture management and quality control of same
Biological indicator management
Bioburden testing
Water sampling
Microbiological media management and quality control of same
Sterilization activities
Research experiments as deemed appropriate by client management
Method Validation/Qualification
Other microbiological activities
Rotational on-call assignments for responding to alarms
GMP ACTIVITIES:
Prepare GMP documentation as requested by management
Perform laboratory sanitizations and ensure cleanliness of laboratory workspace
Perform equipment sanitizations (incubators / hoods / refrigerators)
Purchase supplies (GMP)
Prepare and send documents to Records Center
We are a company committed to creating inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity employer that believes everyone matters. Qualified candidates will receive consideration for employment opportunities without regard to race, religion, sex, age, marital status, national origin, sexual orientation, citizenship status, disability, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to
HR@insightglobal.com. The EEOC "Know Your Rights" Poster is available
here.
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Bachelor's degree in a scientific discipline (Microbiology or Biological Sciences preferred
In-depth knowledge of GMP standards and regulations
1+ years of experience in the pharmaceutical industry in a microbiology related position
Knowledge of Environmental Monitoring practices (air, water, gas, utilities, surfaces)
Experience with routine product testing (Bioburden, endotoxin, TOC)
Ability to read and analyze EM and Product test results
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.