Quality Control Manager/Team Leader

What is it like to work for Zoetis, the world leader in animal health? Zoetis means something a little different to every colleague, but at our core, our purpose ‘to nurture the world and humankind by advancing care for animals,’ is what unites us in all our roles.

We’re a global animal health company dedicated to serving veterinarians, livestock producers and people who raise and care for farm and companion animals in more than 100 countries. And we’re excited to become a part of the Metro Atlanta, GA, community as we build our newest manufacturing facility to support our growing monoclonal antibody and vaccine portfolios.

We are currently searching for a Quality Control Manager to join our team.

DESCRIPTION

The Quality Control Manager/Team Lead will have overall responsibility to manage and control all Quality Control activities in support of the site’s initial mAbs Bio-packaging Operations and future Biological and Pharmaceutical Operations. Leading all Quality Control activities in accordance with identified Global Zoetis Quality Systems and Standards as well as all relevant regulatory and legislative regulations across the lifecycle of the Site products.

Direct and oversee analytical activities by providing a Fit for Purpose and Safe working environment in which all equipment and methods are in a validated state and compliant with applicable regulations. Management of the Lab operations includes Testing Management of all Site Materials, Raw Materials, In process and Finished Product Samples, Stability Testing, House Retains, Environmental Monitoring, Utilities, and Microbial testing.  Lab management also includes maintenance of laboratory materials necessary to perform testing, maintaining laboratory data integrity, and overseeing laboratory investigations. 

(Near-term) Responsibilities in a Startup Environment: In a startup environment, the Quality Control Manager will adapt quickly to changes, lead in developing and optimizing new processes, and identify opportunities for innovation and improvement. This role involves close collaboration with cross-functional teams, managing inventory and resources efficiently, and troubleshooting unexpected challenges. You will also contribute to scaling Lab processes and Method Transfers, participate in diverse tasks to support the dynamic needs of the startup, and ensure the sustainability and scalability of all procedures as the company grows.  Specific activities would include FAT, SAT, CQV, media fills and engineering runs that lead to stability batches.  The successful candidate will need to be flexible to perform activities outside of the standard Quality Control requirements to assist other departments during scale up of staffing and processes.

KEY RESPONSIBILITIES INCLUDE:

Management of Lab Operations

• Daily batch report review and approval
• External lab management
• 3rd party lab result data entry
• OOS trending and reporting.
• Stability testing
• Environmental Monitoring
• Internal Sample Management
• Internal testing
• Laboratory supplies

Internal Lab Management

• Obtain testing and retention samples from bulk containers of raw ingredients and finished products.
• Maintain accurate records of all testing performed in a manner consistent with cGMP regulations.
• Ensure laboratory equipment is maintained and calibrated according to the maintenance schedule.
• Assures that products conform to established specifications of purity, quality, and composition.

Standardized Testing

• Works with support of the Site Quality Leader to establish in-house assay methods and criteria for assays from independent laboratories.
• Keep all product file information current and up to date.
• Makes recommendations to improve Product Quality/Product Assurance/cGMP standards.
• Create relevant and appropriate laboratory SOPs.
• Create various specification documents.
• Assist with various activities relating to regulatory compliance.
• Reviewing, testing, and approving Finished, WIP, and raw materials for use and their associated batch reports
• Sampling of raw materials in accordance with cGMPs, as they are received in warehouse
• Maintaining all documents associated with FDA, USDA, EMA and cGMP compliance
• Other QA/QC related tasks

Staff and Leadership Responsibilities

• Stewardship of the Quality Culture within the Quality Operations Function as well as the Site.
• Support the development of Quality goals and targets as part of the organization’s strategic plan.

EDUCATION AND EXPERIENCE

• Bachelor of Science, Biological sciences, Chemistry, or other related scien