Ivory Systems
Talent Acquisition Specialist at Ivory Systems
Job Title: QC Microbiology Analyst
Responsibilities
Perform utilities sampling of Water for Injection, Purified Water, Clean Steam and Process gases.
Conduct environmental monitoring of cleanroom suites and laboratory areas as required.
Carry out QC Microbiology laboratory testing including bioburden, endotoxin, sterility, and microbial ID testing to ensure timely generation and reporting of test results for In‑Process, Drug Substance, Drug Product, and Stability samples.
Support routine QC operations, including instrument qualification and maintenance, SOP generation and revision, specification update, record keeping and archival.
Manage inventory of reagents and supplies for the laboratory.
Investigate laboratory deviations, including OOS, out of trend, and invalid assays.
Implement corrective actions and preventive actions (CAPAs).
Participate in facility qualification activities for microbiological testing and environmental monitoring.
Gown into cleanrooms with various classifications and stand and move around for extended periods of time.
Participate in method transfer and validation activities, including protocol preparation, execution, and report preparation.
Undertake any other duties as required.
Required Skills
Minimum of 2 years of experience in an FDA‑regulated biotechnology or pharmaceutical company.
5+ years of experience preferred.
Working knowledge and experience with microbiological testing methods such as endotoxin, bioburden, sterility testing, microbial identification, PCR, biological indicators, environmental monitoring, etc.
Familiarity with USP/EP and cGMP/EU GMP regulations.
Experience with instrument and equipment validation.
Credible and confident communicator (written and verbal) at all levels.
Strong analytical and problem‑solving ability.
Hands‑on approach with a ‘can do’ attitude.
Ability to prioritize and manage time effectively.
Excellent attention to detail in a busy and demanding environment.
Self‑motivated and proactive using own initiative.
Committed to learning and development.
Education Bachelor's Degree or above in Microbiology, Biology or Biotechnology related scientific discipline.
Seniority level
Associate
Employment type
Contract
Job function
Science, Research, and Quality Assurance
Pharmaceutical Manufacturing and Biotechnology Research
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Responsibilities
Perform utilities sampling of Water for Injection, Purified Water, Clean Steam and Process gases.
Conduct environmental monitoring of cleanroom suites and laboratory areas as required.
Carry out QC Microbiology laboratory testing including bioburden, endotoxin, sterility, and microbial ID testing to ensure timely generation and reporting of test results for In‑Process, Drug Substance, Drug Product, and Stability samples.
Support routine QC operations, including instrument qualification and maintenance, SOP generation and revision, specification update, record keeping and archival.
Manage inventory of reagents and supplies for the laboratory.
Investigate laboratory deviations, including OOS, out of trend, and invalid assays.
Implement corrective actions and preventive actions (CAPAs).
Participate in facility qualification activities for microbiological testing and environmental monitoring.
Gown into cleanrooms with various classifications and stand and move around for extended periods of time.
Participate in method transfer and validation activities, including protocol preparation, execution, and report preparation.
Undertake any other duties as required.
Required Skills
Minimum of 2 years of experience in an FDA‑regulated biotechnology or pharmaceutical company.
5+ years of experience preferred.
Working knowledge and experience with microbiological testing methods such as endotoxin, bioburden, sterility testing, microbial identification, PCR, biological indicators, environmental monitoring, etc.
Familiarity with USP/EP and cGMP/EU GMP regulations.
Experience with instrument and equipment validation.
Credible and confident communicator (written and verbal) at all levels.
Strong analytical and problem‑solving ability.
Hands‑on approach with a ‘can do’ attitude.
Ability to prioritize and manage time effectively.
Excellent attention to detail in a busy and demanding environment.
Self‑motivated and proactive using own initiative.
Committed to learning and development.
Education Bachelor's Degree or above in Microbiology, Biology or Biotechnology related scientific discipline.
Seniority level
Associate
Employment type
Contract
Job function
Science, Research, and Quality Assurance
Pharmaceutical Manufacturing and Biotechnology Research
#J-18808-Ljbffr