Quality Control Director

Job Title:

Quality Control Director

Job Description

The Quality Control Director leads the Quality Control (QC) department, providing strategic direction, technical expertise, and hands-on support to ensure all testing and processes meet stringent regulatory standards. This role oversees in vitro and in vivo assays for product release, potency, and titer monitoring, and supports the growth of antigens for assay reagents. The director ensures full compliance with USDA regulations, drives continuous improvement in methods and processes, and maintains high standards of documentation accuracy and data integrity within an animal health laboratory environment.

Responsibilities

+ Lead and manage direct reports in the Quality Control department, providing clear direction, performance feedback, and professional development.

+ Provide mentorship to scientists, including on-site technical troubleshooting, guidance on experimental design, and support with complex laboratory challenges.

+ Perform benchwork as needed, including in vitro and in vivo assays for product release, potency testing, titer monitoring, and growing antigens for assay reagents.

+ Oversee all aspects of the Quality Control department, ensuring operational efficiency, scientific rigor, and adherence to established procedures.

+ Ensure all testing, processes, and standard operating procedures (SOPs) comply with USDA regulations and relevant 9 CFR requirements for biologic product release testing.

+ Identify opportunities to increase efficiency through improved methods and processes, including the evaluation and implementation of new techniques and workflows.

+ Mitigate risk by developing and refining processes and methods that enhance quality, reliability, and regulatory compliance.

+ Review documentation to ensure all records are completed accurately, thoroughly, and in accordance with internal and regulatory standards.

+ Review data and bench records to verify the accuracy of results and the validity of conclusions, ensuring robust scientific interpretation.

+ Conduct records review, including batch record and serial release document review, and coordinate shipping of samples to USDA and preparation of 2008 submissions.

+ Collaborate effectively with cross-functional teams while also working independently to drive projects and initiatives to completion.

+ Design studies and experiments, analyze data, and draw independent conclusions that inform product release decisions and process improvements.

+ Work efficiently under pressure, manage multiple priorities, meet deadlines, and handle interruptions while maintaining high quality standards.

Essential Skills

+ Minimum 7 years of experience in an industry Quality Control setting within an animal health company or USDA laboratory.

+ Background in a QC setting at an animal health company or USDA-CVB laboratory, with experience in USDA product release requirements.

+ Extensive experience with in vitro immunoassay development, including assay design, optimization, and validation.

+ Previous experience leading and managing a small team in a Quality Control environment.

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Demonstrated proficiency in mathematical calculations for formulating buffers and reagents.

+ In-depth knowledge of 9 CFR requirements for biologic product release testing and associated SAMS and VS Memos.

+ Expert proficiency in aseptic technique, microbiology, and cell culture.

+ Strong technical skills in ELISA, SDS-PAGE, and western blotting.

+ Ability to design studies and experiments, analyze complex data sets, and form sound scientific conclusions independently.

+ Ability to work efficiently under pressure, meet deadlines, and manage interruptions while maintaining accuracy and attention to detail.

+ Ability to collaborate effectively with teams and also work independently as needed.

Additional

Skills & Qualifications

+ BS, MS, or PhD in Microbiology, Biology, Molecular Biology, or a related scientific discipline.

+ Previous laboratory experience in a USDA-CVB regulated setting is strongly preferred.

+ Experience working in a USDA-licensed animal health industry quality control setting or USDA laboratories.

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Experience with GLP or GMP…