Sterile Drug QC Microbiology Analyst

Automatic Data Processing, Inc.; Columbus (OH); Presencial; USD 60.000 - 85.000; Jornada completa

Descripción de la vacante

Automatic Data Processing, Inc. seeks a Laboratory Analyst in Columbus, OH to perform routine and advanced microbiological testing for sterile drug products in a 503B facility. You will follow USP methods and maintain compliant documentation under cGMP guidelines.

Role requires meticulous attention to detail, data integrity, and proficiency with laboratory instruments and LIMS/ELN systems in a fast-paced environment. Some weekend work may be required.

Formación

• Bachelor's degree in Microbiology, Biology, Chemistry, Biochemistry, or related field.
• 3+ years in a regulated environment (503B, CGMP, QC, GLP, or similar).
• Working knowledge of USP compendia methods for sterile products.

Responsabilidades

• Analytical and microbiological testing.
• Perform compendia I testing on materials, in-process samples, and finished products (USP <71>, <61>, <791>, <785>, <788>, <790>).
• Perform growth promotion tests, media qualifications, and sterility qualifications as required.
• Execute method suitability and verification activities per SOPs and regulatory guidance.
• Support environmental monitoring investigations by analyzing isolates and trends.

Conocimientos

Excellent communication

Attention to detail

Technical proficiency

Problem solving

Teamwork

Compliance mindset

Educación

Bachelor's degree in Microbiology/related field

Herramientas

LIMS/ELN platforms

Microsoft Office

Descripción del empleo

Automatic Data Processing, Inc. seeks a Laboratory Analyst in Columbus, OH to perform routine and advanced microbiological testing for sterile drug products in a 503B facility. You will follow USP methods and maintain compliant documentation under cGMP guidelines.

Role requires meticulous attention to detail, data integrity, and proficiency with laboratory instruments and LIMS/ELN systems in a fast-paced environment. Some weekend work may be required.