QC Microbiology/Environmental Monitoring Specialist

Job Title: QC Microbiology/Environmental Monitoring Specialist

Job Number: 35437

Location: San Diego, CA

Job Description

$66-105K
A position is immediately available in our Quality Control (QC) group for a Microbiology/Environmental Monitoring Specialist to focus on environmental monitoring (EM) program design. The primary responsibility of this role will be to ensure that the environmental monitoring program meets all regulatory requirements. The individual will collaborate with the Manufacturing Department to maintain cleanroom conditions, support manufacturing operations, and ensure compliance with GMP standards.

Responsibilities

• Assess and further develop routine environmental monitoring (EM) program, including surface, air, and personnel monitoring, to ensure the production facility meets GMP standards.
• Trend, review, and write environmental monitoring data reports for the facility.
• Schedule and monitor routine and non-routine microbiological testing of materials and cell therapy products (growth promotion, endotoxin, mycoplasma, sterility)
• Collaborate closely with the Manufacturing Department to align cleanroom monitoring with production schedules and ensure timely reporting of results.
• Collect and analyze environmental samples, ensuring accurate data entry and documentation in accordance with SOPs and regulatory guidelines.
• Maintain detailed records and reports on cleanroom conditions, including temperature, humidity, and pressure differentials.
• Ensure that all monitoring equipment is calibrated and maintained according to internal procedures and manufacturer specifications.
• Participate in internal audits and regulatory inspections to demonstrate the effectiveness of the environmental monitoring program.
• Develop, revise, and review SOPs and other documentation related to environmental monitoring, ensuring compliance with GMP requirements.
• Review environmental monitoring data, including data forms, logbooks, batch records, and other required documentation according to and in compliance with cGMPs, CFRs, and SOPs.
• Train and mentor other staff in environmental monitoring techniques and proper cleanroom behavior to maintain cleanroom integrity.
• Drive continuous improvement initiatives related to environmental monitoring processes and cleanroom operations.

Required Skills

Requirements:

• Bachelor’s degree in a relevant scientific discipline (e.g., Biology, Microbiology, Environmental Science) is required.
• 5+ years of experience working in a GMP/GLP environment, with a focus on environmental monitoring.
• Strong knowledge of cleanroom operations, including environmental monitoring techniques, microbial sampling, and air quality testing.
• Strong understanding of GMP requirements and regulatory standards for cleanroom environments.
• Experience with Climet systems is a plus.
• Excellent attention to detail and ability to maintain accurate records.
• Strong collaboration and communication skills to work effectively with the Manufacturing Department and other cross-functional teams.
• Proficiency with data entry systems, such as QT9, and general computer skills including MS Office.
• Ability to work independently while adhering to strict timelines and maintaining a clean and organized work environment.

Work Environment / Physical Demands:

• Must be able to sit and stand for extended periods.  
• Must be able to lift / carry reports and materials up to 40 pounds, move about the office.
• Able to fully gown and work in an ISO 7 manufacturing area.