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Senior Microbiology Specialist
Our client is a leader in the pharmaceutical industry and is looking for a Senior Microbiology Specialist to join their team. The company is healthcare focused and operates a 24/7 GMP-regulated facility.
Salary/Hourly Rate:
$75k – $90k
Position Overview:
The Senior Microbiology Specialist will provide technical and leadership expertise to develop and maintain compliance procedures for microbiology program, identify any gaps in compliance, and create a corrective and preventative action plan.
Responsibilities of the Senior Microbiology Specialist:
- Develop and lead the microbiology compliance program
- Identify gaps in compliance and write corrective and preventative plans
- Collaborate with R&D, external partners, or contract labs on projects
- Write or update Standard Operating Procedures
- Support validation activities and testing
- Responsible for writing non-conformance evaluation and root cause investigations
- Support inspection audits by outside agencies as necessary
- Responsible to lead the plant environmental program
- Trend, review, and write data reports
- Conduct manufacturing assessments
- Review cleaning record logbooks
- Assist with periodic GMP walkthroughs
- Present updates on projects to management
Qualifications for the Senior Microbiology Specialist:
- 4+ years of experience in a pharmaceutical manufacturing environment
- Strong understanding of microbiology procedures, laboratory processes, and regulatory compliance
- Knowledge of the manufacturing equipment design and maintenance, environmental monitoring programs, and cleaning and sanitization processes and validations
- Hands-on experience with deviation investigations, analyzing, and interpreting issues
- Understanding of cGMP and cGLP practices
Education Requirements:
- Bachelor’s or Master’s degree in microbiology, biology, or a scientific related discipline is required
Benefits:
- Client-provided benefits
EOE/M/F/D/V/SO
Recommended Skills
- Assessments
- Auditing
- Biology
- Certified Global Meeting Planner
- Environmental Monitoring
- Leadership
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Job ID: 118072
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