Microbiology QA Analyst II - Night Shifts, On-Site

Dendreon; Seal Beach (CA); On-site; USD 70,000 - 93,000; Full time

Job summary

Dendreon seeks a Quality Analyst II, Microbiology to perform daily lab operations related to product release and environmental monitoring within the cGMP/FDA framework. This on-site role at Seal Beach requires overnight shifts across three 12-hour periods per week, with strict adherence to procedures and data integrity.

Responsibilities include environmental monitoring, sterility testing, sample traceability, investigations, and SOP maintenance, with opportunities to contribute to method

Qualifications

• Bachelor's degree in a scientific discipline or equivalent.
• 5+ years in a cGMP/FDA regulated industry.
• Strong knowledge of basic lab testing techniques.
• Intermediate analysis skills to evaluate data.
• Familiarity with problem-solving tools and quality systems.

Responsibilities

• Performs routine environmental monitoring (air, surface, water) and testing.
• Performs in-process and final product sterility testing.
• Receives and maintains traceability of test samples, reagents and materials.
• Initiates lab investigations and nonconformance reports for out-of-limit samples.
• Performs routine laboratory equipment maintenance and SOP updates.
• Assists with training of QC personnel and data presentation.

Skills

Bachelor's degree

5+ years cGMP experience

Lab testing techniques

Data analysis

Problem solving

Attention to detail

Regulatory knowledge

MS Office

Education

Bachelor's degree in scientific discipline

Tools

Sterility testing methods

Environmental monitoring equipment

Job description

Dendreon seeks a Quality Analyst II, Microbiology to perform daily lab operations related to product release and environmental monitoring within the cGMP/FDA framework. This on-site role at Seal Beach requires overnight shifts across three 12-hour periods per week, with strict adherence to procedures and data integrity.

Responsibilities include environmental monitoring, sterility testing, sample traceability, investigations, and SOP maintenance, with opportunities to contribute to method