Senior QC Microbiologist

Senior QC Microbiologist I Lexington KYOur Work MattersAt Kindeva we make products that save lives ensuring better health and well-being for patients around the KindevaPurpose-driven work environment Significant growth potential Collaborative team culture Direct impact on patient care Industry-leading innovation The Impact You Will MakeAs 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 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 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 Testing & Method DevelopmentDevelop 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. Environmental & Laboratory SupportSupport 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 & DocumentationSupport 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 QualificationsBA/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 RequirementsRegularly 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.#LI-Onsite #WH