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Quality Control Manager (Microbiology)
Location:
Elwood, KS
Description:
At Elanco (NYSE: ELAN) – it all starts with animals! As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. We’re driven by our vision of ‘Food and Companionship Enriching Life’ and our approach to sustainability – the Elanco Healthy Purpose™ – to advance the health of animals, people, the planet and our enterprise. At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights. Making animals’ lives better makes life better – join our team today! 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. 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. Your Role: * 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 business 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 microbiological and 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. What you will need to succeed (minimum qualifications): * Education: 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. What will give you the competitive edge (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. Other Information: * Location: Elwood, KS (Onsite) * Travel: Minimal travel up to 10% Elanco Benefits and Perks: We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose! Some highlights include: * Multiple relocation packages * Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO) * 8-week parental leave * 9 Employee Resource Groups * Annual bonus offering * Flexible work arrangements * Up to 6% 401K matching 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
Company:
Elanco
Posted:
June 25 on Equest
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More About this Listing: Quality Control Manager (Microbiology)
Quality Control Manager (Microbiology) is a Quality Assurance Quality Control Manager Job at Elanco located in Elwood KS. Find other listings like Quality Control Manager (Microbiology) by searching Oodle for Quality Assurance Quality Control Manager Jobs.
Quality Control Manager (Microbiology) is a Quality Assurance Quality Control Manager Job at Elanco located in Elwood KS. Find other listings like Quality Control Manager (Microbiology) by searching Oodle for Quality Assurance Quality Control Manager Jobs.