Job Description
Job Summary (QCI):
- 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.
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.
Additional Requisition Requirements (QCI):
- 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 client 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, client Instrumentation, PCR, BacT/ALERT systems.
Job Summary (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.
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 (QCII):
- Bachelors or higher degree in the biological sciences or related field required.
- Minimum of 1-2 years relevant laboratory 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, client Instrumentation, PCR, BacT/ALERT systems preferred.
- Familiarity with laboratory data systems such as MODA, LIMS, etc. preferred.