Onsite position:

Wed-Saturday 7:00 AM - 5:30 PM -

South San Francisco What You'll Be Doing Product Release:

Review and release products based on established QC metrics and rigorous quality standards.

Data Monitoring:

Continuously monitor QC data to identify trends and ensure process stability.

Issue Resolution:

Lead investigations into product, process, and quality issues to identify and mitigate risks.

Quality Compliance:

Review CAPAs and process deviations; perform thorough root cause analysis (RCA) to prevent recurrence.

Reporting:

Prepare comprehensive product and process quality reports by collecting, analyzing, and summarizing key information and performance trends.

Documentation:

Draft and review critical product quality documentation and Standard Operating Procedures (SOPs).

Regulatory Adherence:

Ensure all laboratory activities follow strict regulatory guidelines and

ISO 13485

requirements. What You'll Bring to the

Team Education:

BS or MS in Biochemistry, Chemistry, Molecular Biology, or a related scientific field.

Experience:

2+ years of professional experience in an industrial Operations or QC setting.

Communication:

Excellent verbal and written communication skills with the ability to collaborate across departments.

Preferred Qualifications Quality Standards:

Strong working knowledge of QC/QA principles, including GMP and

ISO 13485

environments.

Molecular Biology:

Proficiency in techniques such as PCR, Cloning, and NGS.

Analytical Expertise:

Hands-on experience with spectroscopy, gel electrophoresis, and fragment analysis.

Systems & Automation:

Familiarity with automated robotic platforms and Laboratory Information Management Systems (LIMS).

Problem Solving:

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