Specialist, Quality Control, Microbiology

Novartis Group Companies; Morrisville (NC); On-site; USD 77,000 - 143,000; Full time

Job summary

An established industry player is seeking a Quality Control Specialist to ensure compliance with quality standards in a GMP manufacturing facility. This role involves performing essential microbiological testing and environmental monitoring, alongside data review and report writing. The ideal candidate will have a Bachelor's degree in a related field and at least five years of GMP experience. With a strong focus on detail and accuracy, you will be integral in maintaining safety and quality standards while supporting cross-functional teams. Join a dynamic environment where your expertise will contribute to innovative solutions and regulatory compliance.

Benefits

Sign-on Bonus

Stock Options

Health Benefits

Paid Time Off

Qualifications

• 5+ years of GMP experience in microbiological testing.
• Strong knowledge of quality standards and compliance.

Responsibilities

• Execute environmental monitoring and microbiological testing.
• Review data for compliance and perform trend analysis.
• Prepare laboratory metrics for QMR meetings.

Skills

Microbial Techniques

Data Analysis

Quality Compliance

Environmental Monitoring

Report Writing

Education

Bachelor's in Biochemistry

Bachelor's in Biology

Bachelor's in Microbiology

Job description

Job Description Summary

This position will be located in Durham, NC, and is not eligible for remote work.

The Specialist, Quality Control, supports the organization by ensuring compliance through testing and monitoring of quality standards in manufacturing. The role involves performing environmental monitoring and microbiological testing at the GMP manufacturing facility, along with data review and report writing.

Key Responsibilities:

1. Execute routine and non-routine analyses, including microbial techniques such as environmental monitoring, bioburden, endotoxin, growth promotion, sterility, and cell culture assays.
2. Assist in evaluating controls, risk assessments, and maintaining documentation to ensure safety, quality, and regulatory compliance.
3. Review data for compliance, report abnormalities, perform trend analysis, and draw conclusions.
4. Deliver work with attention to detail and accuracy, ensuring schedule adherence and escalation as needed.
5. Support risk assessments and participate in audit walk-throughs.
6. Compile data for documentation, including stability testing and formulation studies.
7. Escalate issues with solutions to management when timelines are at risk.
8. Prepare and present laboratory metrics for QMR meetings.
9. Investigate non-conforming results, complete deviations, OOS/OOT/OOE investigations.
10. Develop and revise SOPs, protocols, and reports.
11. Oversee special projects related to microbial and instrument troubleshooting.

Responsibilities:

• Bachelor's degree in Biochemistry, Biology, Microbiology, or related field with at least 5 years' GMP experience.
• Ability to gown for aseptic areas and lift approximately 25 pounds.
• Proactively raise concerns with multiple solutions.
• Act as SME on cross-functional teams and during inspections.
• Resolve issues creatively, evaluate factors in data analysis, and select appropriate methods.
• Work independently with minimal instruction on daily tasks and general guidance on new assignments.
• Network with senior internal and external personnel in own expertise area.

Compensation and Benefits: The starting salary range is $77,000 to $143,000 per year, effective from 1/1/25 to 12/31/25, subject to adjustments based on market and individual factors. Benefits include a sign-on bonus, stock options, discretionary awards, health and financial benefits, and paid time off. Final salary and benefits depend on the specific offer and location.

Additional Notes: Visa sponsorship is not available for this role. Relocation support is not provided; applicants must be able to work at the specified location.

EEO Statement: The Novartis Group of Companies is an Equal Opportunity Employer, committed to diversity and inclusion.

Accessibility: Reasonable accommodations are available for applicants with disabilities. Contact [e-mail] or call [phone] with your request and include the job requisition number.