Scientist II, QC Microbiology Specialist

11 hours ago

Lakewood, New Jersey, United States Renaissance LLC Full time
Job Title: Scientist II, QC Microbiology

Renaissance LLC is seeking a highly skilled Scientist II, QC Microbiology to join our team. As a key member of our Quality Control Microbiology Laboratory, you will be responsible for testing and reporting cGMP test results, providing training and support to less experienced team members, and ensuring compliance with current GMP requirements and company safety policies.

Responsibilities:
  • Perform microbiological analysis on received test samples, including raw materials, bulk, final product, stability, and water, as per USP, in-house, or customer methods.
  • Evaluate, record, and report data under minimal supervision.
  • Perform environmental monitoring, as required, and evaluate, record, and report data.
  • Perform quality control testing of media, reagents, and identification materials.
  • Maintain adequate inventory of media and materials required for testing.
  • Initiate proper documentation upon discovery of deviations and out-of-specification results, complete Trackwise write-up for deviations and out-of-specification results.
  • Perform special projects as assigned, including testing, compiling, and trending of data and report generation.
  • Perform data entry for tracking and generates trend analysis reports for EM program, etc.
  • Revises SOPs, forms, protocols, and other controlled documents.
  • Perform micro identifications using manual testing and automated systems.
  • Maintain lab stock cultures for evaluative testing and make dilutions of stock cultures as required by procedure, protocol, or USP requirements.
  • Maintain intradepartmental communication to support company goals.
  • Reviews laboratory logbooks to ensure compliance with good documentation practices.
  • Release manufacturing areas after recovery using the ASCN in Trackwise. Write Trackwise notifications and deviations and complete CAPAs. Create and complete Trackwise change controls. Write and revise SOPs, forms, risk assessments, and other controlled documents.
  • Interact with Operations staff to facilitate data and documentation corrections. Interact routinely with departments such as Production, Quality Assurance, and Regulatory Affairs.
  • Create purchase orders as needed.
Qualifications:
  • Bachelor's degree in biology, health science, or microbiology.
  • 2-5 years' experience in cGMP micro expertise.

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