Job Description

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 diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, 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 .

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Skills and Requirements

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 null

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion,sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military oruniformed service member status, or any other status or characteristic protected by applicable laws, regulations, andordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to HR@insightglobal.com.