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Senior Analyst, QC Microbiology

Newark, CA 94560

Posted: 09/13/2023 Employment Type: Contract Job Category: Scientific Job Number: 584396 Is job remote?: No Country: United States

Job Description

  • Performs EM /Micro QC sampling and testing to support the release of utilities, facility and product
  • Support implementation of EM IT System (MODA) and LIMS
  • Maintains compliance status of laboratories by monitoring equipment, instruments, EM plates, reagents and ensuring adherence to GMP requirements
  • Maintains availability of laboratory supplies EM plates, media, reagents by monitoring inventories closely.
  • Manages EM and Utility sampling and testing schedule and chain of custody of samples
  • Performs all activities in accordance with cGMP requirements and reports discrepancies. Initiates and completes laboratory discrepancy events within expected timelines.
  • Documents testing activities and results, ensuring completeness and accuracy per cGMP.
  • Demonstrates hands-on knowledge of operation, maintenance and troubleshooting of instrumentsas well as GMP requirements pertinent to quality control labs. Performs easy to moderate equipment troubleshooting as needed.
  • Drives laboratory maintenance and 5S activities.
  • Supports Discrepancy Management investigations and implementation of corrective and preventive actions.
  • Performs aseptic techniques training and oversee
  • Assists and troubleshoots with assay performance.
  • Contributes toward the development, revision, application, maintenance, validationand review of methods SOPs. Initiates and follows up on change request for SOP revisions.
  • Assists with addressing questions during GMP audits and supports inspection-related needs as required.
  • Manages multiple tasks concurrently and effectively.
  • Maintains working relationships with peers, department management, and other departments (e.g, QA, Facility & Engineering, and Manufacturing)

  • Demonstrated knowledge in “core” laboratory techniques including aseptic techniques, EM sampling and testing, LAL, Bioburden, Growth Promotion, TOC, etc.
  • Previous working experience in aseptic techniques and EM/Microbiological methods is required
  • Experience in maintenance of GMP laboratory, laboratory equipment, and the status of pipettes and supplies. Able to perform QC laboratory maintenance related duties as assigned
  • Experience supporting Invalid, OOE, and OOS investigations and CAPA initiation
  • Experience authoring SOPs, EM trend reports, and validation protocols
  • Experience with EM System-MODA is plus
  • Able to follow instructions and SOPs precisely and able to keep accurate and contemporaneous documentation
  • Able to learn new skills rapidly and achieve proficiency. Detail-oriented with good written and verbal communication skills
  • Able to seek and receive input from senior team members for the performance of assignments as needed.
  • Ability to solve problems of moderate complexity and troubleshooting as necessary
  • Good writing skill, Good organizational and planning skills, and an ability to work efficiently
  • Team player with good interpersonal skills

  • A minimum B.S. degree in a scientific discipline with 4-7 years of experiences in a cGMP compliant environment or equivalent combination of education and experience
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