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