QC Analyst I-Microbiology

Schedule

• Sun-Thu 2pm-11pm

Position Summary

The Quality Control Analyst I for the QC Microbiology Department will be responsible for performing processing of routine environmental monitoring samples, product-release testing, and raw material testing. The position requires the utmost attention to detail, good organizational skills, computer proficiency, and a basic understanding of microbiology and laboratory instrumentation. In addition, effective communication skills and the ability to function in a fast-paced, highly technical environment with minimal supervision are essential for success.

Responsibilities

• Performs sterility testing and endotoxin testing of raw materials, in-process samples and finished products
• Performs growth promotion of microbial media
• Performs environmental monitoring, including air viable particulate, non-viable particulate and surface sampling and personnel monitoring
• Prepares environmental monitoring excursion reports and conducts minor laboratory investigations
• Receives raw materials and supplies for the QC laboratory and maintains laboratory supplies, media and reagents inventory
• Adheres to standard operating procedures and good documentation practices to ensure data integrity and traceability
• Assists the QC Supervisor/Leads with managing proper overall operation of department (physical inventories, logs, documentation, filing, etc.)
• Maintains familiarity with QC-relevant current Good Manufacturing Practices (cGMP) guidance (CFR, USP, EP, ICH, etc.)
• Responsible for assisting with routine laboratory upkeep and organization
• Reviews test results of other QC analysts for accuracy and precision and maintains an efficient workflow of all required testing documentation ensuring timely submission relative to product release dates
• Perform all other related duties as assigned

Qualifications

• Bachelor's degree in biology or relevant scientific discipline required
• Minimum 0-2 years relevant laboratory experience or experience in a cGMP and/or FDA regulated industry or a combination of education and related work experience required
• May consider less education and professional experience upon successful completion of the company's internship program
• Ability to work in Clean Room environment with full gowning requirements
• Ability to work independently or as a team member
• Detail-oriented with strong written and verbal communication skills
• Demonstrated knowledge in Microbiology and aseptic techniques
• Ability to problem-solve and troubleshoot as necessary
• Familiarity with laser particle counters, viable air samplers, microscope, Endosafe® Instrumentation, PCR, BacT/ALERT systems

Pay

• The max pay rate is 21.13/hr for this position