Microbiology and Quality Assurance Manager
3 weeks ago
Abbott Laboratories is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines.
Our MissionWe are committed to improving the health and well-being of people around the world. Our mission is to provide innovative solutions that help people live healthier, more fulfilling lives.
Job SummaryWe are seeking a highly skilled and experienced Microbiology and Quality Assurance Manager to join our team. As a key member of our quality assurance team, you will be responsible for ensuring the quality and safety of our products, as well as leading our microbiological testing and quality control programs.
Responsibilities- Responsible for microbiological testing of ingredients, in-process, finished product, and various environment/utility tests.
- Lead corrective action/preventive action (CAPA) for microbiological non-conformities.
- Develop, implement, and monitor laboratory methods and document reviews.
- Responsible for incoming testing of ingredients.
- Lead corrective action/preventive action (CAPA) for microbiological and incoming quality non-conformities.
- Represent the incoming quality assurance function for all external quality and regulatory audits.
- Assess and implement continuous improvement of laboratory efficiency and productivity.
- Manage the department budget and assess and implement applicable cost improvement plans related to the lab and microbial testing.
- Technical resource for the plant and technical liaison for other business units.
- Represent the microbiology function for all external quality and regulatory audits.
- Manage the site internal microbiology audit program.
- Conduct applicable internal audits annually.
- Review global corrective actions and assess whether site action is required.
- Responsible for GMP compliance, manufacturing quality, laboratory support, and quality planning.
- Hire and retain a diverse, highly qualified staff and provide ongoing performance feedback. Set goals that align to department plans and manage the execution of goals through coaching and mentoring. Maintain a safe and professional work environment.
- Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
- Bachelor's Degree in Microbiology, Bacteriology, Chemistry, Chemical Engineering, Biology, or other technical degree.
- Minimum 10 years of experience in nutrition, food, or allied industry.
- Minimum 5 years of supervisory management.
- Minimum 5 years of working in a regulated FDA/GMP environment.
We offer a competitive salary, comprehensive benefits package, and opportunities for professional growth and development. If you are a motivated and experienced professional looking for a new challenge, we encourage you to apply.
Abbott Laboratories is an Equal Opportunity Employer and a Military/Veteran friendly Employer, committed to employee diversity.
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