Quality Control Analyst I

February 18, 2026
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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.