QC Microbiology Specialist – Aseptic QC & EM (Onsite)

JOHNSON SERVICE GROUP; Carlsbad (CA); On-site; USD 56,000 - 67,000; Full time

Job summary

Johnson Service Group is seeking a Quality Control Associate, Microbiology in Carlsbad, CA to support aseptic fill/finish operations, environmental monitoring and microbiological testing. The role emphasizes cGMP compliance, contamination control, and process validation within a biotech manufacturing setting.

The candidate will perform routine EM, SOP/QA document work, and participate in investigations and continuous improvement projects.

Qualifications

• Combination of undergraduate coursework and on-the-job experience in Microbiology or a related discipline.
• Minimum three years of experience in Quality Control and environmental monitoring of GMP facilities.
• Strong communication, integrity and ability to work independently.

Responsibilities

• Serve as SME for microbiological assays during audits, risk assessments, investigations, and client visits.
• Support assay transfer, qualification and validation activities for microbial-based assays or client methods.
• Draft, revise and review QC SOPs and assay qualification protocols and reports.
• Perform analysis on in-process samples, APIs, raw materials, and stability samples using established methods.
• Conduct routine environmental monitoring of GMP/GLP facilities for particulates and surface viables.
• Initiate and participate in environmental monitoring excursions investigations and impact assessments.
• Support gowning qualification program for manufacturing and QC personnel.
• Perform monitoring of lab water and gas systems; conduct endotoxin, bioburden, growth promotion testing.

Skills

Oral communication

Written communication

Problem solving

Documentation

Independent work

Education

Undergraduate coursework in Microbiology or related discipline

Tools

Microsoft Office

Quality software

21 CFR 11 applications

Job description

Johnson Service Group is seeking a Quality Control Associate, Microbiology in Carlsbad, CA to support aseptic fill/finish operations, environmental monitoring and microbiological testing. The role emphasizes cGMP compliance, contamination control, and process validation within a biotech manufacturing setting.

The candidate will perform routine EM, SOP/QA document work, and participate in investigations and continuous improvement projects.