QC Analyst I-Microbiology

Schedule:
Tue-Sat 2pm-11pm
Sun-Thu 2pm-11pm
Interview Process:
Virtual interview for 45 minutes


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.

ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Performs environmental monitoring, including air viable particulate, non-viable particulate and surface sampling and personnel monitoring
• 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
• Participates with maintaining proper overall operation of department (physical inventories, logs, documentation, filing, etc.)
• Responsible for assisting with routine laboratory upkeep and organization
• Utilizes GMP systems such as MODA and other laboratory computer systems
• Reviews test results of other QC analysts for accuracy and precision and maintains and efficient workflow of all required testing documentation ensuring timely submission relative to product release dates
• Perform all other related duties as assigned.

QCII
The Quality Control Analyst II for the QC Microbiology Department will be responsible for performing routine environmental monitoring, product testing, and raw material testing. The position requires the utmost attention to detail, very strong 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.

ESSENTIAL DUTIES AND 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 and efficient workflow of all required testing documentation ensuring timely submission relative to product release dates
• Perform other related duties as assigned
Additional Requisition Requirements    
QCI:
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 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, microProduct, Endosafe® Instrumentation, PCR, BacT/ALERT systems

QCII
QUALIFICATIONS:
• Bachelors or higher degree in the biological sciences or related field required
• Minimum of 1-2 years relevant laboraty experience or experience in a cGMP/FDA regulated industry, or a combination of years of educated and relevant laboratory experience or experience in a cGMP/FDA regulated industry
• Demonstrated knowledge in Microbiology and aseptic techniques required
• Ability to work independently or as a team member
• Ability to work in Clean Room environment with full gowning requirements
• Ability to problem-solve and troubleshoot as necessary
• Detail-oriented with strong written and verbal communication skills
• Familiarity with laser particle counters, viable air samplers, microProduct, Endosafe® Instrumentation, PCR, BacT/ALERT systems preferred
• Familiarity with laboratory data systems such as MODA, LIMS, etc preferred