Overview
On Site
BASED ON EXPERIENCE
Contract - Independent
Contract - W2
Contract - 6+ mo(s)
Skills
MICROBIOLOGY
MICROBIOLOGIST
GMP
GXP
MODA
LABWARE LIMS
LIMS
ELECTRONIC LABORATORY SYSTEMS
Job Details
Our direct client a large global pharmaceutical company is seeking to hire a QC Microbiologist Specialist for a contract role.
Environmental Monitoring & Data Trending
Quality Systems & Compliance
Equipment & Technology Management
Project & Documentation Management:
Benefits:
We offer a competitive compensation package that includes:
Thank you,
Ashu
Job Title - QC Microbiologist Specialist
Onsite - 100%
Duration: 6 months plus
Location: Social Circle, GA, USA 30025
Microbiology Testing & Method Lifecycle
- Perform and oversee GMP microbiological testing for raw materials, intermediates, and finished products.
- Lead method development, validation, and transfer activities in compliance with compendial and regulatory standards.
- Manage trending and analysis of assay controls and invalid assay results to identify patterns and drive continuous improvement.
Environmental Monitoring & Data Trending
- Implement and maintain environmental monitoring programs for cleanrooms and controlled areas.
- Perform statistical analysis of monitoring data using Minitab or similar tools to assess state of control.
Quality Systems & Compliance
- Lead and manage change control activities impacting QC processes and analytical methods.
- Conduct and document laboratory investigations in TrackWise; develop and implement CAPAs.
- Ensure alignment with USP, EP, and applicable regulatory agency guidelines.
Equipment & Technology Management
- Oversee qualification and onboarding of analytical equipment for microbiology and analytical testing.
- Utilize and maintain electronic laboratory systems such as MODA and LabWare LIMS.
Project & Documentation Management:
- Lead cross-functional QC projects, including continuous improvement initiatives and technology upgrades.
- Author and review technical documents, including protocols, SOPs, final reports, and data summaries.
- Present data and recommendations to management and regulatory inspectors as needed.
Benefits:
We offer a competitive compensation package that includes:
- [Pay Rate]: $70 - $80 per Hour
- Note: Pay rate will be commensurate with experience.
- Medical for full time employees
- Dental, and Vision Insurance
- Life Insurance, Short-Term Disability, Long-Term Disability, etc.
Thank you,
Ashu
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