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Smithfield Foods · 15 hours ago

Associate Regulatory Affairs Manager - BioScience

Cincinnati, OH

Full-time

Onsite

Mid, Senior Level

3+ years exp

Smithfield Foods is an American food company with a leading position in packaged meats and fresh pork products. The Associate Regulatory Affairs Manager will ensure compliance with cGMP and FDA regulations, conduct audits, and maintain quality assurance records while providing technical expertise in product safety and quality.

Food and BeverageHospitality

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

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

Qualification

CGMP knowledgeFDA regulations knowledgeQuality management systemsStatistical process controlRecord keeping practicesMulti-taskingWritten communicationVerbal communicationAttention to detailTeamwork

Required

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 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