Novartis

MicrobiologySpecialist

$0–0k Durham, North Carolina, United States FULL TIME
The Brief

“Microbiology Specialist at Novartis. Skills: Microbiological testing, Method verification, Environmental monitoring, Data review, Trending, Technical documentation. Perform microbiological qualification, release, stability, and investigational testing to support compliant manufacturing operations.. Author and maintain protocols and reports for microbiology and environmental monitoring method verification and validation activities.”

What You'll Achieve.

Ensuring the quality, safety, and integrity of our products; Delivering high-quality medicines to patients worldwide

Industry & Context.

Problems you'll solve

Problem Solving Skills; Investigations; Deviations; Change controls

Eligibility Requirements

Ability to gown for entry into aseptic areas, Lift approximately 25 pounds

What They're Looking For.

Must Have

Bachelor’s degree in biochemistry, biology, microbiology, or a related scientific discipline., Minimum five years of experience working in a Good Manufacturing Practice environment., Proven experience performing microbiological testing, including utilities testing and environmental and personnel monitoring., Demonstrated ability to write protocols, verification documentation, and technical reports using Good Documentation Practice., Experience reviewing and approving laboratory data, supporting deviations, investigations, and change controls., knowledge of Good Laboratory Practice and Good Documentation Practice principles., Understanding of United States Food and Drug Administration and European Medicines Agency regulatory expectations., Ability to gown for entry into aseptic areas and lift approximately 25 pounds.

What You'll Do.

Perform microbiological qualification

and investigational testing to support compliant manufacturing operations.

Author and maintain protocols and reports for microbiology and environmental monitoring method verification and validation activities.

Execute method transfers and verifications for microbiology and environmental monitoring assays across laboratory systems.

Maintain qualification

and trending of critical reagents

and microbiology controls.

Review and approve routine and transfer data

supporting deviations

and quality investigations.

Coordinate environmental monitoring performance qualification

and utilities qualification activities.

Perform microbiological testing of materials

and environmental and personnel monitoring samples.

Analyze trends and performance indicators while supporting sample planning and execution across laboratory activities.

How You'll Work.

Team & Collaboration

Partner closely with cross-functional teams to support investigations, qualifications, and continuous improvement initiatives.

Communication Scope

Communication Skills

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