Smithfield Foods
Associate Regulatory Affairs Manager - BioScience
Smithfield Foods, Cincinnati, Ohio, United States, 45208
Associate Regulatory Affairs Manager - BioScience
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Associate Regulatory Affairs Manager - BioScience
role at
Smithfield Foods .
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As part of our FS/QA team, you will conduct routine sanitation checks, ensuring that HAACP and USDA regulations are strictly enforced. You will provide technical expertise to track product from start to finish and develop corrective actions when needed, ensuring that we safely deliver the best Smithfield Bioscience Heparin to our customers and consumers.
The Associate QA/Regulatory Affairs Manager enforces current Good Manufacturing Practices (cGMP), ensures compliance with FDA regulations, and communicates with customers regarding quality agreements, maintaining the quality and integrity of the Company’s products and quality systems.
Core Responsibilities
Enhance cGMP and FDA regulatory compliance and assist in preparation and maintenance of standard operating procedures.
Assist in internal, supplier, customer, and FDA audits.
Safeguard, maintain, and monitor the Company’s quality assurance records.
Safeguard and monitor the Company’s laboratory notebooks and production records.
Inspect the Company’s products, packaging, and labels for dispatch.
Prepare and circulate validation protocols and reports.
Assist in the development of new laboratory methods and investigations.
Communicate closely with the QA Manager, laboratory, and production managers on compliance matters.
Complete required applicable forms in English, requiring reading and writing in English.
Learn and stay up to date on applicable regulatory requirements.
Assist in establishing procedures based on current regulatory best practices.
Support the preparation of regulatory filings.
Help with customer/regulatory correspondence and participate in on-site quality audits.
The above statements describe the general nature and level of work performed. They are not an exhaustive list of all responsibilities, duties, and skills required. Other duties may be assigned as needed.
Qualifications
Bachelor’s degree from a regionally accredited four-year college or university in science or a related field and 3+ years of relevant experience; or an equivalent combination of education and experience.
Knowledge of quality management systems, 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 complete applicable forms in English.
Ability to work well with others in a fast‑paced, dynamic environment.
Respectful, approachable, and team‑oriented, building strong working relationships and a positive work environment.
Supervisory Responsibilities
Provide leadership and guidance to employees in the Quality Assurance and Regulatory Affairs Department.
Carry out supervisory responsibilities in accordance with the organization’s policies and applicable laws.
Interview, hire, and train employees; plan, assign, and direct work; appraise performance; reward and discipline; address complaints and assist in providing appropriate resolutions.
Relocation Package No.
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 veteran 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.
Seniority level
Entry level
Employment type
Full‑time
Job function
Legal
Industries
Food and Beverage Manufacturing
Referral Program Referrals increase your chances of interviewing at Smithfield Foods by 2x.
#J-18808-Ljbffr
Associate Regulatory Affairs Manager - BioScience
role at
Smithfield Foods .
Apply Now!
As part of our FS/QA team, you will conduct routine sanitation checks, ensuring that HAACP and USDA regulations are strictly enforced. You will provide technical expertise to track product from start to finish and develop corrective actions when needed, ensuring that we safely deliver the best Smithfield Bioscience Heparin to our customers and consumers.
The Associate QA/Regulatory Affairs Manager enforces current Good Manufacturing Practices (cGMP), ensures compliance with FDA regulations, and communicates with customers regarding quality agreements, maintaining the quality and integrity of the Company’s products and quality systems.
Core Responsibilities
Enhance cGMP and FDA regulatory compliance and assist in preparation and maintenance of standard operating procedures.
Assist in internal, supplier, customer, and FDA audits.
Safeguard, maintain, and monitor the Company’s quality assurance records.
Safeguard and monitor the Company’s laboratory notebooks and production records.
Inspect the Company’s products, packaging, and labels for dispatch.
Prepare and circulate validation protocols and reports.
Assist in the development of new laboratory methods and investigations.
Communicate closely with the QA Manager, laboratory, and production managers on compliance matters.
Complete required applicable forms in English, requiring reading and writing in English.
Learn and stay up to date on applicable regulatory requirements.
Assist in establishing procedures based on current regulatory best practices.
Support the preparation of regulatory filings.
Help with customer/regulatory correspondence and participate in on-site quality audits.
The above statements describe the general nature and level of work performed. They are not an exhaustive list of all responsibilities, duties, and skills required. Other duties may be assigned as needed.
Qualifications
Bachelor’s degree from a regionally accredited four-year college or university in science or a related field and 3+ years of relevant experience; or an equivalent combination of education and experience.
Knowledge of quality management systems, 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 complete applicable forms in English.
Ability to work well with others in a fast‑paced, dynamic environment.
Respectful, approachable, and team‑oriented, building strong working relationships and a positive work environment.
Supervisory Responsibilities
Provide leadership and guidance to employees in the Quality Assurance and Regulatory Affairs Department.
Carry out supervisory responsibilities in accordance with the organization’s policies and applicable laws.
Interview, hire, and train employees; plan, assign, and direct work; appraise performance; reward and discipline; address complaints and assist in providing appropriate resolutions.
Relocation Package No.
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 veteran 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.
Seniority level
Entry level
Employment type
Full‑time
Job function
Legal
Industries
Food and Beverage Manufacturing
Referral Program Referrals increase your chances of interviewing at Smithfield Foods by 2x.
#J-18808-Ljbffr