Quality Control Manager/Team Leader

Zoetis; Atlanta (GA); On-site; USD 90,000 - 100,000; Full time

Job summary

A leading global animal health company is seeking a Quality Control Manager/Team Leader in Atlanta, GA. The role involves managing Quality Control activities, ensuring compliance with regulations, and leading a team in a startup environment. The ideal candidate will have a strong background in quality systems and regulatory compliance, with a focus on continuous improvement and innovation.

Qualifications

• Minimum of 5 years progressive experience in Quality Control.
• Minimum of 3 years leadership experience preferred.

Responsibilities

• Manage and control all Quality Control activities.
• Oversee analytical activities and ensure compliance with regulations.
• Lead in developing and optimizing new processes.

Skills

Quality performance

Attention to detail

Communication

Problem solving

Education

Bachelor of Science

Job description

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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
• OOS trending and reporting.
• Stability testing
• 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.
• 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.
• 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 sciences.
• Demonstrated knowledge of compliance, quality and scientific principles in a FDA regulated environment is required.
• Environmental Monitoring experience preferred.
• Minimum of 5 years progressive experience in the Quality Control
• Minimum of 3 years leadership experience (Preferred)
• Detailed knowledge of Good Laboratory Practices (GLP) and Good Manufacturing Practices (cGMP).
• Lean Labs Qualification is desirable.

TECHNICAL SKILLS and COMPETENCIES REQUIRED

• Fluency in quality systems and regulatory compliance.
• Driven / Passionate about Quality performance and delivering results.
• Must be well-organized, detail oriented, and able to work within deadlines as well as under pressure.
• Exercises Good Judgment and Drives Change- using appropriate influence techniques.
• Strong written and oral communication skills as well as negotiation skills
• Confident decision maker, self-accountability with an ability to develop and adhere to self-directed standard work.
• Drives for Superior Results
• Inspires Continuous Improvement and Breakthrough Thinking - utilizing problem solving tools such as Lean and Six Sigma
• Ability to manage multiple projects simultaneously and prioritize work, goals and tasks in accordance with Quality and Business objectives
• Fluent in English (written and spoken).
• Demonstrated written communication skills, as well as experience with presenting to leadership teams.
• Business Fluency and awareness and Ability to be a trusted partner.

PHYSICAL POSITION REQUIREMENTS

• This is full time position based at the Site.
• This position will require fluent use of teleconferencing tools, as well as SharePoint technologies and MS Office tools, to share and manage information

Note: This description indicates the general nature and level of work expected. It is not designed to cover or contain a comprehensive listing of activities or responsibilities required of the incumbent. Incumbent may be asked to perform other duties as required. Additional position specific requirements/responsibilities are contained in approved training curricula.

About Zoetis

At Zoetis, our purpose is to nurture the world and humankind by advancing care for animals. As a Fortune 500 company and the world leader in animal health, we discover, develop, manufacture and commercialize vaccines, medicines, diagnostics and other technologies for companion animals and livestock. We know our people drive our success. Our award-winning culture, built around our Core Beliefs, focuses on our colleagues' careers, connection and support. We offer competitive healthcare and retirement savings benefits, along with an array of benefits, policies and programs to support employee well-being in every sense, from health and financial wellness to family and lifestyle resources.

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Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Manufacturing, Production, and Quality Assurance

• Industries

  Pharmaceutical Manufacturing

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