Senior QC Microbiology Specialist: EM & Endotoxin Testing

Bora Biologics; San Diego (CA); On-site; USD 85,000 - 115,000; Full time

Job summary

Bora Biologics is seeking a Senior Associate, QC Microbiology to perform and review routine environmental and utilities monitoring for cGMP facilities. You will test microbiological and chemical parameters, trend data, support validations, and draft protocols and SOPs to ensure product quality and regulatory compliance.

The role emphasizes timely reporting of results, investigations as needed, and cross-functional collaboration with Manufacturing, QA, and Validation teams to maintain site

Qualifications

• BS or advanced degree in a related scientific discipline, or equivalent combination of education and experience.
• BS with 3 years or MS degree with 0-3 years of progressively responsible experience in pharmaceutical or biologics production environments.

Responsibilities

• Perform Bioburden and endotoxin testing of in-process and product samples.
• Environmental monitoring (EM) of classified cleanrooms and controlled areas.
• Collect and test water samples from purified water and WFI systems.
• Revise SOPs and test methods as required.
• Review data generated in the Microbiology lab.
• Execute method suitability testing, performance qualifications and various studies.
• Conduct investigations of microbiological quality events and support CAPA implementation.
• Collaborate cross-functionally with Manufacturing, QA, and Validation teams.
• Author quarterly and yearly trend reports.
• Handle sample management including receiving, logging, tracking, storing, and disposal.

Skills

GLP knowledge

cGMP regulations

Documentation practices

Laboratory techniques

Data trending

Microsoft Office

Problem solving

Education

BS or MS in life sciences

Tools

Laboratory equipment

Job description

Bora Biologics is seeking a Senior Associate, QC Microbiology to perform and review routine environmental and utilities monitoring for cGMP facilities. You will test microbiological and chemical parameters, trend data, support validations, and draft protocols and SOPs to ensure product quality and regulatory compliance.

The role emphasizes timely reporting of results, investigations as needed, and cross-functional collaboration with Manufacturing, QA, and Validation teams to maintain site