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Wathena

    Manager, Quality Control - Wathena, United States - Elanco Animal Health Incorporated

    Elanco Animal Health Incorporated
    Elanco Animal Health Incorporated Wathena, United States

    3 weeks ago

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    Description
    As a leading global animal health company, Elanco delivers innovative products and services to improve the health of pets and farm animals around the world because we believe making animals' lives better, makes life better. Since 1954, we have provided solutions that support veterinarians, farmers and pet owners to advance our vision of Food and Companionship Enriching Life. Elanco's promise to employees: Together, we foster an inclusive culture where everyone can make a difference, encouraging ownership, growth and well-being.

    Why Work at Elanco? We Save Puppies

    Working at a monoclonal antibody start-up facility in Elwood, Kansas presents an exciting opportunity to contribute to cutting-edge research: Monoclonal antibodies are an innovative type of biologic drug that can target specific molecules in the body to treat a variety of diseases, including cancer and autoimmune disorders. Working at a start-up facility that is developing and manufacturing these drugs at a commercial scale is an opportunity to be on the forefront of medical research and contribute to developing treatments that can have a significant impact on pets' lives. Our newest product is a one-time injection that is 100% effective in curing the deadly parvovirus in puppies Elwood is 60 min North of downtown Kansas City and 15 min from St. Joseph, MO.

    Position Description:

    The QC Manager is primarily responsible for the regulatory compliant analytical testing of facilities, raw materials, intermediate, and final products for release, sale and distribution of product into these markets. The QC Manager is responsible for the safety, productivity and development of the employees, the quality of the work process established, the integrity of the analytical results, and excellence in customer service. Regulatory compliance is paramount for the success of our business, as is the safety and wellbeing of our employees. The role will be responsible for building a high performing team and systems by addressing all current and future needs and building short and long-term quality plans for the area.

    Responsibilities:
    • Lead department personnel and be responsible for Quality Control. Includes talent management; building bench strength and setting clear objectives for performance and accountability.
    • The Manager of Quality Control will actively build and maintain strong relationships with QC staff and customers, to assure delivery of stakeholder needs.
    • Leads Quality Control's strategic planning and quality yearly objective setting that meet compliance requirements and business needs.
    • Plan and implement change / new processes to assure that procedures and practices remain current with busines needs and the ability to satisfy the twin needs of compliance and productivity.
    • Oversees laboratory operations, responsible for testing/inspecting and releasing materials for use in product manufacturing and packaging and final product testing.
    • Interface with R&D, Technical Services and Manufacturing Science (TSMS), Engineering, Supply Chain and Quality to successfully in-transfer and launch new mAb products including the validation and maintenance of new assays.
    • Responsible for timely investigating, CAPA, and reporting results of analytical testing in compliance with QMS and Management escalations procedures.
    • Accountable for quality performance of the function and delivery against site quality targets.
    • Build and grow the QC function, recruiting and developing talent in alignment with the site's strategic needs.
    • Ensure all QC staff are properly trained for their roles and operate in adherence with corporate and regulatory standards.
    • Maintain a safe work environment and establish a strong safety culture in compliance with Elanco standards and all applicable government requirements.
    Minimum Qualification:
    • Bachelor's degree and 5+ years of lab experience OR a HS Diploma/GED with at least 8 years of applicable lab experience. Science related field preferred
    • Established leader with ability to demonstrate action-oriented deliverables while maintaining strong engagement with staff.
    • Strong understanding of the functional areas of quality control. Knowledge of microbiology, biochemistry and laboratory operations.
    • Must Manage through complexity: laying out a strategic plan and overseeing the tactical implementation, driving improved operational and quality metrics.
    • Strong written and verbal communications skills (English), excellent interpersonal skills
    • Understanding of cGMP standards for manufacture of veterinary biologics.
    • Demonstrated success operating within a matrixed organization.
    • Must be able to wear appropriate gowning and personal protective equipment (PPE) in production and manufacturing support areas.
    Additional Preferences:
    • Experience in Production, QA, Manufacturing Science & Technology, Regulatory is desirable.
    • Previous experience with regulatory agencies requiring GMP or GLP from USDA, FDA, EU preferred.
    • Demonstrated problem solving experience, identifying and understanding issues, problems, and opportunities.
    Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status
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