Microbiologist

Category:

Life Science

Employment Type:

Direct Hire

Reference:

BH-384730

Yoh Life Sciences
is hiring a Microbiologist
for our Irvine, CA client. This role will be responsible for environmental controls in an aseptic processing operation, and all other microbiology testing related to customer products and operations.

Industry: Biopharmaceuticals
Location: Irvine, CA
Compensation: $25-35/hr
Type: Permanent
Shift:
M-F 8-5pm

Essential Functions and Responsibilities
-


Duties:

• Maintains qualification for all microbiology sampling procedures and test methods; performs testing as needed to support business needs.
• Coordinates with contracts testing laboratories and experts as needed.
• Reviews process and testing documentation as needed to ensure complete and accurate records are maintained.
• Assists in the conduct of vendor audits as a microbiology subject matter expert, as needed.
• Extensive experience in Microbiology and EM groups and can lead actively and / or participate in technical projects pertaining to microbiology related testing processes, including but not limited to method development, transfer and validation activities, sanitization studies, media fill qualification activities, etc.

• Performs method validation/ suitability for microbiological tests, specifically bioburden and sterility testing.
• Performs trending analyses of data collected via environmental, personnel and utility monitoring in support of investigations, Quality Management Review, Annual Product Review, etc.; publish conclusions and make recommendations for process changes as applicable.
• Investigates and documents any identified excursions or trends, including root cause analysis, impact assessment, and identification of corrective / preventive actions.
• Plans and implements corrective and preventive actions (including procedure and test method revisions), and assists/measures the effectiveness of such changes.
• Assesses processes and procedure changes proposed by others for potential impact on environmental monitoring / microbiology testing processes.
• Authors technical protocols and reports for QC Microbiology.
• Writes protocols, review data, and write final reports.
• Prepares reports for other Microbiological tests.
• Develops and prepares Environmental Monitoring Trend reports specifically for an aseptic manufacturing facility.

• 4-year degree in biology relate fields (i.e., biology, biochemistry, microbiology, etc.)
• 3+ years of experience in commercial biotechnology or pharmaceutical production environment preferred.