Senior QC Microbiologist I - Lexington, KY

The Impact You Will Make

As a Senior QC Microbiologist I, you will serve as an experienced, hands-on member of our Quality Control Microbiology team, supporting the microbiological testing and method development activities that help ensure the quality and safety of our pharmaceutical products.

This role will have a strong focus on product microbiology, including routine testing as well as the development, qualification, and improvement of microbiological methods for raw materials, components, in-process materials, and finished products. You will perform and troubleshoot compendial microbiological testing, support investigations and laboratory compliance activities, and author the technical documentation necessary to maintain a cGMP-compliant and inspection-ready laboratory.

You will join a collaborative QC Microbiology team while bringing the experience to independently execute testing and method-development activities and provide technical support to less-experienced members of the laboratory.

Responsibilities

Microbiological Testing & Method Development

• Develop, qualify, and improve microbiological methods for raw materials, components, in-process materials, and finished product testing in alignment with GMP, USP, and ICH standards.
• Perform release and/or stability testing on excipients, components, drug substances, and drug products.
• Execute and troubleshoot compendial microbiological testing, including:
• USP Microbial Enumeration Tests
• USP Tests for Specified Microorganisms
• USP Tests for Burkholderia cepacia complex
• USP Antimicrobial Effectiveness Testing
• USP Particulate Matter in Injections
• USP Biological Indicators
• Perform sample receipt, management, testing, enumeration, and reporting.

Environmental & Laboratory Support

• Support and/or perform environmental monitoring activities, including surface bioburden, airborne bioburden, airborne particle monitoring, and monitoring of purified water and utilities.
• Support environmental monitoring trending and report creation.
• Operate, maintain, and clean laboratory equipment and instruments according to SOP requirements.
• Maintain appropriate inventory of reagents, media, materials, and laboratory supplies.
• Perform laboratory cleaning, maintenance, and waste-disposal activities.
• Perform a variety of laboratory support activities and assist other laboratory personnel as assigned.

Investigations, Compliance & Documentation

• Support deviation investigations, OOS/OOT investigations, CAPA implementation, and change control management.
• Author and revise SOPs, test methods, protocols, reports, forms, technical assessments, and other laboratory documentation.
• Support laboratory readiness for internal audits, customer audits, and regulatory inspections.
• Strictly adhere to all cGMP requirements, SOPs, Good Documentation Practices, and site safety procedures.
• Perform other duties as assigned.

Basic Qualifications

• BA/BS degree in Biology, Microbiology, Life Sciences, or a related field.
• Minimum of five (5) years of experience in a cGMP laboratory environment.
• Intermediate proficiency with Microsoft Office, including Word, Excel, and Outlook.
• Good verbal and written communication skills.
• Qualified to work with controlled substances.

Physical Requirements

• Regularly use hands to handle laboratory materials and supplies.
• Use computers for extended periods throughout the workday.
• Effectively communicate by telephone and electronic communication.
• Regularly stand and walk for extended periods.
• Occasionally lift and/or move up to 50 pounds.
• Use proper lifting techniques and maintain awareness of workplace hazards.
• Follow all site safety procedures and requirements.

Join our One Team mission of manufacturing more tomorrows. Your expertise will help ensure better health and well-being for patients worldwide.

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