Specialist, Quality Control, Microbiology

Novartis; Durham (NC); On-site; USD 77,000 - 143,000; Full time

Job summary

An established industry player is seeking a Specialist in Quality Control to support compliance and testing in microbiology. This role is crucial for ensuring quality standards in manufacturing, involving environmental monitoring, microbiological testing, and data analysis. You will collaborate with internal and external stakeholders while maintaining rigorous documentation and adherence to safety and regulatory compliance. Join a community dedicated to changing lives through science and enjoy a comprehensive benefits package, including a competitive salary and sign-on bonus. If you have a passion for quality and a strong background in microbiology, this opportunity is perfect for you.

Benefits

Sign-on bonus

Stock units

Medical insurance

401(k)

Paid time off

Qualifications

• 5+ years of GMP experience in microbiology.
• Ability to perform microbiological analyses and ensure compliance.

Responsibilities

• Execute microbiological analyses and maintain compliance documentation.
• Review data and report findings for quality assurance.

Skills

Microbiological Testing

Environmental Monitoring

Data Analysis

Problem-Solving

Documentation

Education

Bachelor's degree in Biochemistry

Bachelor's degree in Biology

Bachelor's degree in Microbiology

Job description

Specialist, Quality Control, Microbiology

Join to apply for the Specialist, Quality Control, Microbiology role at Novartis.

This position will be located at Durham, NC and will not have the ability to be remote.

Summary
This role involves supporting compliance, testing, and monitoring of quality standards in manufacturing. The specialist performs environmental monitoring and microbiological testing, reviews data, and reports findings.

Key Responsibilities

• Execute routine and non-routine microbiological analyses, including environmental and utilities monitoring, bioburden, endotoxin, sterility, and cell culture assays.
• Evaluate controls, communication, risk assessments, and maintain documentation for safety, quality, and regulatory compliance.
• Review data for compliance, report abnormalities, perform trend analysis, and draw conclusions.
• Maintain attention to detail and accuracy, ensure schedule adherence, and support audits and risk assessments.
• Prepare documentation, investigate non-conformances, and author/revise SOPs and reports.
• Oversee microbial and instrument troubleshooting projects and develop testing methods.

Minimum Qualifications

• Bachelor's degree in Biochemistry, Biology, Microbiology, or related field.
• Minimum 5 years of GMP experience.
• Ability to gown for aseptic areas and lift approximately 25 pounds.
• Effective problem-solving skills and the ability to work with minimal supervision.
• Network with internal and external stakeholders.

Additional Information

• Salary range: $77,000 - $143,000/year, depending on experience and location.
• Benefits include sign-on bonus, stock units, medical, 401(k), and paid time off.
• Note: No visa sponsorship or relocation support available. Must be accessible to Durham, NC.

Why Novartis: Join a community committed to changing lives through science and collaboration. Learn more at our culture.

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Benefits & Rewards: Discover more at our benefits page.

EEO Statement: We are an equal opportunity employer. We value diversity and inclusion.

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