Rahway, NJ, 07065, USA
2 days ago
Microbiologist - Environmental Monitoring
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 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 Human Resources Request Form (https://airtable.com/app21VjYyxLDIX0ez/shrOg4IQS1J6dRiMo) . The EEOC "Know Your Rights" Poster is available here (https://www.eeoc.gov/sites/default/files/2023-06/22-088\_EEOC\_KnowYourRights6.12ScreenRdr.pdf) . To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/ . 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.
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