- Perform QC Microbiology laboratory testing including bioburden, endotoxin, sterility, and microbial ID testing to ensure timely generation and reporting of test results (for In-Process, Drug Substance, Drug Product, and Stability samples) in support of manufacturing operations.
- Support routine QC operations, including but not limited to: instrument qualification and maintenance, SOP generation and revision, specification update, record keeping and archival, etc.
- Manage inventory of reagents and supplies for the laboratory.
- Conduct laboratory investigations, including OOS, Out of Trend, deviations, and invalid assays.
- Implement corrective actions and preventive actions (CAPAs).
- Participate in facility qualification activities for microbiological testing and environmental monitoring.
- Required to gown into cleanrooms with different classifications and able to stand and move around for extended periods of time.
- Participate in method transfer and method validation activities, including protocol preparation, protocol execution, and report preparation.
- Bachelor's Degree or above in Microbiology, Biology or Biotechnology related scientific discipline.
- Minimum of 2 years of working experience in an FDA-regulated biotechnology or pharmaceutical company.
- Working knowledge and experience with microbiological testing methods such as endotoxin, bioburden, sterility testing, microbial identification, PCR, biological indicators, environmental monitoring, etc.
- Familiar with USP/EP and cGMP/EU GMP regulations.
- Familiar with instrument and equipment validation.
- Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint).
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Microbiology Lab Analyst
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Joulé Piscataway, NJ, United StatesType: Temporary (possibility for conversion into permanent employee) · Our client is a fully-integrated biopharmaceutical company with global R&D, clinical, regulatory, and manufacturing capabilities. They are seeking a Microbiologist to work closely with Management on department ...
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Microbiology Analyst QC CAR-T
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J&J Family of Companies Raritan, United StatesMicrobiology Analyst QC CAR-T W · **Description** · Janssen Pharmaceutical, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for an Analyst, Quality Control - Microbiology CAR-T Manufacturing (2nd Shift) in Raritan, NJ · At the Janssen Pharmaceutical Compa ...
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Microbiology Analyst QC CAR-T
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Johnson & Johnson Raritan, United StatesJanssen Pharmaceutical, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for an Analyst, Quality Control - Microbiology CAR-T Manufacturing (2nd Shift) in Raritan, NJ · At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create ...
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Laboratory Technician
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EMSL Analytical, Inc Cinnaminson, United StatesEMSL is seeking a Full Time **Laboratory Technician (Microbiology) **in **Cinnaminson, NJ**. The technician supports the laboratory analysts by preparing samples for analysis. No laboratory experience is required, just a desire to learn technical skills and become proficient in c ...
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Laboratory Analyst
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EMSL Analytical, Inc Cinnaminson, United StatesEMSL is seeking a **Laboratory Analyst** **(Asbestos) **in **Cinnaminson, NJ.** No laboratory experience is required, just a desire to learn technical skills and become proficient in common laboratory practices and procedures. On-the-job training will be provided for all new empl ...
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Regulatory Specialist
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Novitium Pharma Hightstown, United StatesRegulatory Specialist (East Windsor, NJ) (Multiple Openings). Review, manage and write regulatory submissions electronically which include New ANDA filings, Complete Response letters, Information requests, Amendments to the ANDA's (Labeling, Chemistry & Bioequivalence) of differe ...
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application analyst-epic beaker
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Montefiore Medical Trenton, United StatesSelect how often (in days) to receive an alert: · Montefiore is ranked among the top hospitals nationally and regionally by U.S. News & World Report. For more than 100 years we have been innovating new treatments, procedures, and approaches to patient care, producing stellar outc ...
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Sr Quality Control Analyst
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Novitium Pharma Hightstown, United StatesSr.QualityControl Analyst (East Windsor, NJ) (Multiple Openings) Conduct research, analysis, synthesis, and experimentation on substances, for such purposes as product and process development & application, quantitative and qualitative analysis, & improvement of analytical method ...
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Quality Control Analyst
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Novitium Pharma Hightstown, United StatesQuality Control Analyst (East Windsor, NJ) (Multiple Openings) Conduct research, analysis, synthesis, and experimentation on substances, for such purposes as product and process development and application, quantitative and qualitative analysis, and improvement of analytical meth ...
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Cosmetics Microbiologist
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IN2U Carteret, United StatesJob Description · Job DescriptionMicrobiologist Cosmetics (Senior level) Job Description · Bioburden panel testing. · Total plate count, Total combined yeast and mold count, enrichment testing. · Test for specific microorganisms (pathogens). · Media growth promotion testing. · Mi ...
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Quality Lab Technician
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Innova Solutions Warren, NJ, United StatesInnova Solutions is immediately hiring a Quality Laboratory Technician · Job Title: Quality Laboratory Technician · Full-time Contract · 06 Per Hour · Note : *Some weekends required as needed* · As a Quality Laboratory Technician, you will: · Carry out responsibilities in ac ...
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Analyst, Laboratory Quality Control
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J&J Family of Companies Raritan, United StatesAnalyst, Laboratory Quality Control (1 of W · Description · Janssen Pharmaceuticals, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for an Analyst, Laboratory Quality Control - CAR-T in Raritan, NJ · At the Janssen Pharmaceutical Companies of Johnson ...
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QC Sr. Lab Tech
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Sun Pharmaceutical Industries New Brunswick, United StatesCOME WORK FOR US - INVESTING IN YOU AS A SUN PHARMA EMPLOYEE · * Medical, Dental, Vision Benefits · * Health Savings Account (HSA), Flexible Spending Account (FSA) · * Prescription Drug Coverage · * Telehealth and Behavior Health Services · * Income Protection - Short Term and Lo ...
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Quality Laboratory Technician
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Innova Solutions Warren, NJ, United StatesInnova Solutions is immediately hiring a Quality Laboratory Technician · Job Title: Quality Laboratory Technician · Position type: Full-time Contract · Duration: 06 Months Possibility of extension · Location: Warren NJ · Pay range: $28 -$31.06 Per Hour · Note : *Some week ...
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Environmental Monitoring Specialist
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Innova Solutions Lansdale, United StatesJob ID: · Lansdale , · Pennsylvania · Job Type: · Contract · Added - a day ago · Job Description · Innova Solutions is immediately hiring a Environmental Monitoring Specialist. · Position Type: Full Time, Contract to possible hire. · Duration: 6+ Months · Location: West Po ...
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Innova Solutions Summit, United StatesInnova Solutions is immediately hiring for a Global External Analytical Services Specialist (Manufacturing). · Job Title: Manufacturing · Position type: Full-time Contract · Duration: 12 Months · Location: Summit, NJ Onsite) · As a Global External Analytical Services Special ...
Microbiology Analyst - Hopewell, United States - GroupA
Description
We are looking for a Microbiology Analyst to join our team in Hopewell, NJ. In this role, you will perform QC Microbiology laboratory activities to support GMP manufacturing, testing and release of materials, intermediates, and finished products under FDA/EU regulations, applicable International Regulations and processes and procedures. Support facility qualification activities for microbiological testing and environmental monitoring.Responsibilities: