QC Microbiology Specialist – Aseptic QC & EM (Onsite)

JOHNSON SERVICE GROUP

Carlsbad (CA)

On-site

USD 77,366,000 - 91,693,000

Full time

14 days+

Application generator

Stand out for this role — generate a tailored resume and cover letter in about a minute.

Get past ATS filters

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.