Kelly Scientific has an immediate need for a QC Manager in Elwood, KS . This is a direct hire opportunity with a leading animal health pharmaceutical company.
Title : QC Manager
Location : Elwood, KS (Relocation assistance provided)
Salary : Commensurate with experience
Summary : 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. Additionally, the QC Manager will oversee the safety, productivity and development of 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 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, 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 company standards and all applicable government requirements.
Minimum Requirements
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
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.
Preferred Skills
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.
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Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.