Senior QC Microbiologist

At Kindeva, we make products that save lives, ensuring better health and well-being for patients around the world. We offer a purpose-driven work environment, significant growth potential, a collaborative team culture, direct impact on patient care, and industry-leading innovation.

About the Role

As a Senior QC Microbiologist I, you will serve as an experienced, hands-on member of our Quality Control Microbiology team, supporting microbiological testing and method development activities to ensure the quality and safety of our pharmaceutical products. This role focuses on product microbiology, including routine testing and 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 technical documentation to maintain a cGMP-compliant and inspection-ready laboratory. You will join a collaborative team while independently executing testing and method-development activities and providing technical support to less-experienced team members.

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.

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.