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BioScience - Associate QA/Regulatory Affairs Manager

Company: Smithfield Foods
Location: Cincinnati
Posted on: December 5, 2019

Job Description:

Job Details Company Overview Your Opportunity Smithfield Foods is a $15 billion global food company and the world's largest pork processor and hog producer. In the United States, the company is also the leader in numerous packaged meats categories with popular brands including Smithfield, Eckrich , Nathan's Famous , Farmland , Armour , Farmer John , Kretschmar , John Morrell , Cook's , Gwaltney , Carando , Margherita , Curly's , Healthy Ones , Morliny , Krakus and Berlinki . Smithfield Foods is committed to providing good food in a responsible way and maintains robust animal care, community involvement, employee safety, environmental and food safety and quality programs. The Associate QA/Regulatory Affairs Manager is one of enforcing current Good Manufacturing Practices (cGMP), ensuring compliance to FDA regulations, communicating with customers regarding quality agreements and of ensuring the quality and integrity of the Company's products and quality systems.Core Responsibilities - Enhances cGMP and FDA regulatory compliance and assists in preparation and maintenance of standard operating procedures. - Assists in internal, supplier, customer, and FDA audits. - Safeguards, maintains and monitors the Company's records pertaining to quality assurance. - Safeguards and monitors the Company's laboratory notebooks and production records. - Inspects the Company's products, packaging and labels for dispatch. - Prepares and circulates validation protocols and reports. - Assists in the development of new laboratory methods and laboratory investigations. - Communicate closely with the Company's QA Manager, laboratory and production managers on compliance matters. - Learn and stay up to date on applicable regulatory requirements - Assist with the establishment of procedures based on current regulatory best practices - Support with the preparation of regulatory filings - Help with customer / regulatory correspondence and participate in on-site quality audits The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. May perform other duties as assigned.Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals to perform the essential functions. - Bachelor's degree from a regionally accredited four-year college or university in science or related field; or equivalent combination of education and experience. - Knowledge and understanding of quality management stems, quality assurance principles, SPC and statistics; preferred. - Knowledge of cGMP and FDA regulations for pharmaceutical products. - Experience in good record keeping practices. - Excellent written and verbal communication skills. - Strong attention to detail. - Ability to manage multiple priorities in a fast-paced environment. - Ability to work well with others in fast paced, dynamic environment. - Ability to be respectful, approachable and team oriented while building strong working relationships and a positive work environment. Supervisory Responsibilities - Provides leadership and guidance to employees in the Quality Assurance and Regulatory Affairs Department. - Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. - Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and assisting in providing appropriate resolutions. EEO/AA Information Smithfield, is an equal opportunity employer committed to workplace diversity. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, gender identity, protected veterans status or status as a disabled individual or any other protected group status or non-job related characteristic as directed by law.Careers and Benefits To learn more about Smithfield's benefits, visit *********************************** Recommended skills Investigation Product Quality Assurance Quality Management Quality Assurance Auditing Regulatory Filings

Keywords: Smithfield Foods, Cincinnati , BioScience - Associate QA/Regulatory Affairs Manager, Executive , Cincinnati, Ohio

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