QA Microbiology Analyst II – Overnight

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

Job summary

Dendreon Pharmaceuticals in Seal Beach, CA, is hiring a Quality Analyst II, Microbiology, to perform daily lab operations related to product release and environmental monitoring, supporting overall department productivity.

The role is on-site with overnight three 12-hour shifts. Candidates should have a scientific degree and 5+ years in a cGMP/FDA environment, strong lab skills, and experience with documentation, SOPs, and data integrity.

Qualifications

• Bachelor’s degree in a scientific discipline or equivalent.
• Typically, 5+ years related experience in cGMP/FDA regulated industry.
• Strong knowledge of basic lab testing techniques.
• Intermediate level of analysis skills to evaluate data and draw conclusions.
• Attention to detail, quality, and compliance with procedures.
• Ability to learn new technologies quickly; understand assay concepts.
• Knowledge of cGMP/QSR/ICH and FDA regulations preferred.
• Proficient in MS Office applications.

Responsibilities

• Performs routine environmental monitoring, including air, surface sampling, and purified water testing.
• Performs sterility testing of products (e.g., BacT/Alert).
• Maintains traceability and integrity of test samples and reagents.
• Initiates laboratory investigations and handles nonconformances.
• Maintains routine laboratory equipment and SOPs.
• Supports method validation studies and data integrity.
• Assists with training of QC personnel.

Skills

Lab testing techniques

Data analysis

Problem solving tools

Attention to detail

MS Office

BacT/Alert

Education

Bachelor's degree in scientific discipline

5+ years in cGMP/FDA regulated industry

Tools

MS Office

BacT/Alert

Job description

Dendreon Pharmaceuticals in Seal Beach, CA, is hiring a Quality Analyst II, Microbiology, to perform daily lab operations related to product release and environmental monitoring, supporting overall department productivity.

The role is on-site with overnight three 12-hour shifts. Candidates should have a scientific degree and 5+ years in a cGMP/FDA environment, strong lab skills, and experience with documentation, SOPs, and data integrity.