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Associate/Senior Associate/Scientist - QC Microbiology

Wuxi Biologics
Avenel, New Jersey, US
Closing date
Jan 25, 2022

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Consultancy/Private Sector
Conservation science
Salary Type
Employment Type
Full time
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Job Summary

The QC Microbiology lab at WuXi Biologics Cranbury site performs test methods such as Bioburden, Endotoxin, EM monitoring, Water monitoring and testing. This QC Associate/Senior Associate/Scientist is responsible for the quality and on-time delivery of test results and other QC deliverables to internal and external clients. He or she shall demonstrate strong oral and written communication skills and actively contributes to training, report generation and documentation.

Job Functions
  • Provides microbiological support for all manufacturing and support activities.
  • Participates in activities such as environmental monitoring, microbiological and chemical sampling of utilities and services, and other tasks as assigned.
  • Performs microbiological and related testing including, but not limited to, bioburden, BET, MLT, TOC, pH, Conductivity, Utility Monitoring, and Growth Promotion.
  • Analysis of analytical test results and reporting of raw data into various laboratory information management systems
  • Perform quarterly and annual data analysis, archiving and trending of Environmental Monitoring and utilities data.
  • In collaboration with the QC Microbiology group members, ensure verification of microbiological methods are designed and executed in conformance with US and international regulatory and company standards commensurate with contractual obligations.
  • In collaboration with the QC Microbiology group members, ensure test methods, Environmental Monitoring Program are designed, and test results are generated in conformance with US and international regulatory and company standards commensurate with contractual obligations.
  • Design and execute microbiological methods which comply with US and international regulatory and company standards for all samples received from the Manufacturing department. This includes, but is not limited to, QC testing to assess the safety of in process samples.
  • Develop and write SOP's, verification protocols, investigations, deviations and OOS reports that are in compliance with US and international regulatory and company standards.
  • Lab support activities such as management of lab consumables and equipment maintenance/work order completion
  • Receives minimal instructions on routine work and detailed instructions on new assignments.

Technical Skills / Knowledge
  • Candidate must possess knowledge and hands-on experience in microbiolocal techniques including, but not limited to, Bioburden, Endotoxin, TOC, Conductivity, Water Testing, Environmental Monitoring, and Growth Promotion.
  • Solid track record of working experience in quality control operation to support clinical and commercial scale manufacturing product testing and regulatory IND/BLA filing.
  • Strong understanding and knowledge on GMP regulation and pharmaceutical microbiology.
  • Provides training on areas of technical expertise and compliance issues relevant to the lab setting.
  • Subject Matter Expert regarding aseptic technique and processing and contributes to related training.
  • Excellent writing skills, judgment, integrity, investigation (as in OOS), ability to work independently

Problem Solving
  • Proven experience in risk mitigation planning and ability to solve complex QC technical and operation problems. Be able to make appropriate judgment and decisions based on available knowledge and data to ensure the safety and success of the manufacturing support and product testing.

Communication Skills
  • Proficiency in English is required. Excellent communications skills (verbal, written, and presentation skills). Must be able to collaborate with clients, internal stakeholders, and support functions to achieve alignment and work effectively.

Education and Experience
  • Bachelor of Science degree and/or advanced Graduate degree in Chemistry, Microbiology, Biochemistry or equivalent field.
  • Associate: 0-2 years of experience; Senior Associate: 2-4 years of experience; Scientist: 5+ years of relevant experience or equivalent for Bachelors', 2+ years for Master's in the Quality Control or related field or equivalent experience.
  • Understanding of the basic principles of Microbiology
  • Experience working in a GMP Lab
  • Aseptic technique
  • Experience with working in a fast-paced and dynamic work environment
  • Experience with working in teams to deliver on business needs

The job description does not intend to list all the duties and responsibilities assigned to this position. Employee holding this position would be required to perform other job-related duties/responsibilities based on their expertise and company business needs.
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