Job Description

About the Company - We are a growing Animal Health company that specializes in the manufacture of biologics and nutrition solutions. Our product portfolio is expanding and we are looking for an experienced QC Manager who is technically strong with QC assays related to in process and final testing of viral, parasitic and bacterin based products.

About the Role - The successful candidate will have a strong background in microbiology, quality testing methods for animal or human pharmaceutical products, and experience working in a USDA or FDA regulated environment. This person has been a key player in the successful license of veterinary vaccines. They are strategic, good at listening to and implementing new ways of doing things and constantly tuned in to process improvement.

Located in Lincoln, Nebraska, we offer the opportunity to make every day a success story and put your mark on our company! Someone that enjoys working cross-functionally with multiple departments, agencies and business partners will thrive in this role. We offer excellent benefits, salary in the range of $90k to $120k plus substantial bonus!

Responsibilities

• Coordinate and oversee in-process and final product testing of vaccines including, but not limited to, virus titration, bacterial enumeration, or sterility testing.
• Understand, troubleshoot and optimize advanced biological lab techniques.
• Direct activities related to qualification of new assay controls and instrumentation (flow cytometers, auto-titrators and others as we expand).
• Stay up to date with USDA-CVB guidelines, Veterinary Service memo’s, 9CFR policies and other relevant documentation as needed.
• Oversee tech transfer activities related to QC.
• Work closely with team members and business partners to meet quality deadlines to license new products.
• Implement new QMS or enhance existing electronic records system.
• Serve as a sounding board to bring in new ways of thinking, new ways of doing things to continuously improve efficiencies.
• Review statistical studies, technological advances, or regulatory standards and trends to stay abreast of issues in the field of quality control.

Qualifications

• 1 to 2 years of supervisory/managerial experience
• Bachelor’s degree in Microbiology, Biology, immunology or related field with 8 years of technical experience in pharma, USDA or related industry OR Master’s with 4 years of same experience
• Experience working in a USDA or FDA regulated environment
• Experience with guidance documents pertaining to veterinary biologics preferred

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