QC Microbiology Analyst - Environmental Monitoring

ALTEN; South San Francisco (CA); On-site; USD 65,000 - 90,000; Full time

Job summary

ALTEN in the United States seeks a QC Microbiology professional to monitor utilities and facilities, perform endotoxin/sterility testing, and manage data in MODA LIMS. The role includes environmental sampling, trend analysis, and CAPA execution to support compliant drug production.

The candidate will work with a collaborative team to ensure timely reporting, maintain equipment, and assist in investigations of OOS results in a fast-paced GMP environment.

Qualifications

• Bachelor's degree in Microbiology (preferred).
• Experience with microbiological techniques: air monitoring, water testing, surface monitoring.
• Experience with sterile gowning, aseptic technique, clean room operations a plus.
• Knowledge of GMP, SOPs and quality control processes.
• Experience with LIMS (MODA) and TOC testing.
• Proficient with MS Office and related apps.
• Excellent communication in a collaborative environment.
• Fast-paced small company adaptability.
• Strong organization and prioritization skills.
• Authorized to work in the U.S.

Responsibilities

• Perform environmental monitoring of utilities and facilities (air, gas, surface, water) and personnel monitoring.
• Perform endotoxin and sterility testing on final drug product and other compendial tests.
• Conduct plate counts and related readouts; report results.
• Perform growth promotion testing, gram staining, and isolate prep for microbial ID.
• Perform TOC testing of water samples and bioburden testing of raw materials.
• Liaise with internal/external partners; ensure supplies and GMP-compliant equipment.
• Enter data into MODA LIMS; monitor trends; prepare reports; update management on trends; implement CAPAs.
• Assist investigations of out-of-specification (OOS) results and microbiology deviations.
• Adhere to cGMP requirements and documented policies.

Skills

Environmental monitoring

Sterility testing

LIMS data entry

TOC testing

Gram staining

QA/documentation

MS Office

GMP knowledge

Team collaboration

Independent work

Education

Bachelor's degree in Microbiology

Tools

MODA LIMS

Sievers M9s

Job description

ALTEN in the United States seeks a QC Microbiology professional to monitor utilities and facilities, perform endotoxin/sterility testing, and manage data in MODA LIMS. The role includes environmental sampling, trend analysis, and CAPA execution to support compliant drug production.

The candidate will work with a collaborative team to ensure timely reporting, maintain equipment, and assist in investigations of OOS results in a fast-paced GMP environment.