Senior QC Microbiologist
About The Position
Our Work Matters At Kindeva, we make products that save lives, ensuring better health and well-being for patients around the world. Why Kindeva? Purpose-driven work environment Significant growth potential Collaborative team culture Direct impact on patient care Industry-leading innovation 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.
Requirements
- 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.
Responsibilities
- 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 <61> Microbial Enumeration Tests, USP <62> Tests for Specified Microorganisms, USP <60> Tests for Burkholderia cepacia complex, USP <51> Antimicrobial Effectiveness Testing, USP <788> Particulate Matter in Injections, USP <55> Biological Indicators
- Perform sample receipt, management, testing, enumeration, and reporting.
- 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.
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
