Document Control Manager Jobs in Lexington, KY (NOW HIRING)

At Kindeva, we make products that save lives, ensuring better health and well-being for patients around the world.

• Collaborative team culture
• Direct impact on patient care

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.

• 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 <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.

• 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.

• 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.

Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.