Analyst I

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

• Perform environmental monitoring of utilities and facilities, including air and gas monitoring (viable and non-viable), surface sampling, water sampling and testing, and personnel monitoring.
• Perform endotoxin and sterility testing on final drug product and other compendial tests as needed.
• Perform aerobic and anaerobic plate count readout, analysis, and reporting.
• Perform media growth promotion testing, gram staining, and isolate preparation for microbial identification.
• Perform TOC testing of water samples
• Perform bioburden and Endotoxin testing of incoming raw materials
• Work with internal and external partners to keep the laboratory operating optimally, including ensuring adequate supplies and maintaining equipment in a GMP-compliant state.
• Enter data into the MODA LIMS, monitor and trend data, assemble reports on environmental monitoring findings, provide management with regular updates on environmental trends, own and implement corrective action plans as needed.
• Assist in investigations of out-of-specification (OOS) results and other microbiology-related deviations.
• Comply with cGMP requirements and documented policies at all times.

• Perform environmental monitoring of utilities and facilities, including air and gas monitoring (viable and non-viable), surface sampling, water sampling and testing, and personnel monitoring.
• Perform endotoxin and sterility testing on final drug product and other compendial tests as needed.
• Perform aerobic and anaerobic plate count readout, analysis, and reporting.
• Perform media growth promotion testing, gram staining, and isolate preparation for microbial identification.
• Perform TOC testing of water samples
• Perform bioburden and Endotoxin testing of incoming raw materials
• Work with internal and external partners to keep the laboratory operating optimally, including ensuring adequate supplies and maintaining equipment in a GMP-compliant state.
• Enter data into the MODA LIMS, monitor and trend data, assemble reports on environmental monitoring findings, provide management with regular updates on environmental trends, own and implement corrective action plans as needed.
• Assist in investigations of out-of-specification (OOS) results and other microbiology-related deviations.
• Comply with cGMP requirements and documented policies at all times.

Skills

• Bachelor's degree in Microbiology (preferred) with minimum of 2 years of experience in a QC Microbiology laboratory or equivalent combination of education and experience.
• Experience in the application of microbiological techniques such as air monitoring gases, water testing, surface monitoring.
• Experience in sterile gowning procedures, aseptic techniques and clean room operations is a plus
• Knowledge of GMP, SOPs and quality control processes
• Experience with LIMS (i.e. MODA) and Sievers M9s for TOC testing is a plus
• Proficient in MS Office and other applications.
• Excellent interpersonal, verbal and written communication skills are in this collaborative work environment.
• Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
• Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines.
• Ability to work independently and as part of a team.
• Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment.
• Candidates must be authorized to work in the U.S.

Education

Bachelor's degree in Microbiology (preferred)