Senior Analyst, QC Microbiology
7400 Gateway Boulevard Newark, CA 94560 US
Job Description
Duties
- 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)
Skills:
- 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
Education:
- 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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