Associate Regulatory Affairs Manager - BioScience

If you are currently employed at Smithfield, please log into Workday and submit your application through the Jobs Hub.

A great job-and a great future-awaits you at Smithfield Foods. We are an American food company with a leading position in packaged meats and fresh pork products. We're looking for motivated people who want to join our team and grow lasting and meaningful careers with us. Apply Now!

As part of our FS/QA team, you would conduct routine sanitation checks, ensuring that HAACP and USDA regulations are strictly enforced. Providing technical expertise to track product from start to finish and develop corrective actions when needed. You will be responsible for ensuring that we are able to safely deliver the best Smithfield Bioscience Heparin on Sodium customers and consumers.

The Associate QA/Regulatory Affairs Manageris 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.

• 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.
• Must have the ability to complete required applicable forms in English, which requires the ability to read and write in English.
• 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.

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 and 3+ years of relevant experience; 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.
• Must have the ability to complete required applicable forms in English, which requires the ability to read and write in English.
• 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.

• 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 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, sex, sexual orientation, national origin, age, gender identity, protected veterans status, status as a disabled individual or any other protected group status or non-job characteristic as directed by law.

If you are an individual with a disability and would like to request a reasonable accommodation for any part of the employment selection process, please call us at 757-357-1595.