QA System Associate-Bioscience

Smithfield Foods, Inc.; Cincinnati (OH); On-site; USD 40,000 - 60,000; Full time

Benefits offered by this job

Relocation package available

Job summary

Smithfield Foods, Inc. is seeking a QA Quality Systems Associate to support the QMS within a regulated pharmaceutical API and medical device component environment. You will help ensure cGMP compliance, data integrity, and regulatory alignment across quality systems.

Join a team focused on continuous improvement, training, and inspection readiness, while maintaining controlled documents and diverse quality initiatives to safeguard patient safety and product quality.

Qualifications

• Requires knowledge of Pharmaceutical quality management systems and cGMP practices.
• Strong writing, communication, collaboration, and problem-solving skills.
• Proficiency with Microsoft Office and regulated manufacturing environments.

Responsibilities

• Support compliance with QMS and regulatory requirements in API/medical device environments.
• Maintain controlled documents (SOPs, specs, test methods, forms).
• Monitor deviations, investigations, CAPA and nonconformances; ensure timely closure.

Skills

Quality systems

cGMP knowledge

Analytical skills

Excellent communication

Microsoft Office

Regulated manufacturing experience

Education

Associate Degree in science or related field

Tools

LIMS

ERP

MES

Document management systems

Job description

Have a seat at our table. When you join Smithfield, you become part of something special - a company that's sustainably feeding people around the world, producing good food the right way with respect for our people, animals, communities and planet. With opportunities across locations and functions, a culture grounded in our Core Four values - gratitude, communication, respect and accountability - and a strong commitment to learning, collaboration, and innovation, Smithfield offers challenging and rewarding careers where you can grow, contribute and make a real impact.

Your Opportunity

The Quality Assurance (QA) Quality Systems Associate supports the Quality Management System (QMS) within a regulated pharmaceutical Active Pharmaceutical Ingredient (API) and medical device component manufacturing environment. This position is responsible for ensuring compliance with current Good Manufacturing Practices (cGMP), Quality Management System requirements, and internal procedures to maintain product quality, patient safety, data integrity, and regulatory compliance.

Core Responsibilities

Support compliance with: ICH Q7 Good Manufacturing Practice for Active Pharmaceutical Ingredients ICH Q9 Quality Risk Management ICH Q10 Pharmaceutical Quality System 21 CFR Parts 210 and 211 21 CFR Part 11 Electronic Records and Electronic Signatures 21 CFR Part 820 / FDA Quality Management System Regulation (QMSR). Assist in maintaining an effective Pharmaceutical Quality Management System. Support quality objectives, continuous improvement initiatives, and inspection readiness activities. Promote quality culture and compliance throughout manufacturing and support functions.

Maintain controlled documents including: SOPs, Specifications, Test methods, Forms, Master Batch Records, Validation protocols and reports. Support document issuance, revision, archival, and periodic review programs. Monitor deviations, investigations, CAPA and nonconformances to ensure timely closure and compliance. Support validation and qualification programs including: Process Validation, Process Performance Qualification (PPQ), Equipment Qualification (IQ/OQ/PQ), Cleaning Validation, Computer System Validation (CSV), and Analytical Method Validation Review validation protocols and reports for compliance and completeness.

Participate in QMS validation execution and documentation review. Complete GMP and quality-related training requirements. Support employee training on quality systems and compliance requirements. Participate in continuous improvement projects focused on quality, compliance, efficiency, and inspection readiness. Identify opportunities to improve quality systems and business processes.

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.

Associate Degree in science or related field from a regionally accredited four-year college or university; or equivalent combination of education and experience, required. Knowledge and understanding of Pharmaceutical quality management systems, preferred. Excellent writing, interpersonal and communication skills (written and verbal). Strong analytical, organizational, and problem-solving skills. Demonstrates professionalism, integrity, accountability, and customer focus. Proficiency in Microsoft Office applications. Ability to work effectively in a regulated manufacturing environment.

Prior experience in pharmaceutical, biotechnology, medical device, or regulated manufacturing industries preferred. Familiarity with: ICH Q7, ICH Q9, 21 CFR Parts 210/211, 21 CFR Part 11, 21 CFR Part 820/QMSR, Data Integrity and ALCOA+ principles preferred. Experience with electronic QMS, LIMS, ERP, MES, or document management systems preferred.

Pay and Benefits

The expected pay range for this position is $40,000 - $60,000 annually. Smithfield Foods provides pay ranges that reflect its good faith estimate of the salary or hourly wage the company reasonably expects to pay for a position at the time of hire. Individual compensation will be determined based on several factors, including but not limited to, the scope and responsibilities of the role, location of the position, the candidate's qualifications and experience, internal equity, external market pay for comparable positions and budget considerations. At Smithfield Foods, base pay represents only one aspect of the comprehensive total rewards package.

Learn more about our benefits package.

Relocation Package Available

EEO and Diversity

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.

Company Culture

At Smithfield, good food starts with good people. Good food. Responsibly. is more than just our tagline; it's what we do. We provide good jobs. We take good care of our animals. We are good stewards of the environment. We do good in our local communities. Smithfield is proud to offer robust, flexible and affordable benefit plans and programs to support our team members and their loved ones, and with out-of-pocket costs, on average, 20 percent less than plans offered by other employers. Beyond our medical plans, our Be Well programs offer tools and resources to enhance your quality of life, at no additional cost. These programs are uniquely tailored to our Smithfield team and provide support for elective surgeries, weight loss, mental health, cancer, kidney disease, diabetes, smoking cessation, asthma, maternity management and more. Our company invests in your future. We offer comprehensive training and professional development programs designed to help you reach your full potential. Through LinkedIn Learning, employees can access on-demand courses, professional certificates, and skill-based training to build capabilities aligned with career and business needs. Our partnership with Guild supports your continuing education with tuition assistance covering English language learning, high school completion, and degree programs, while our leadership development initiatives nurture high-potential talent. We also offer unique benefits like our Smithfield Scholarship Program for employees' children.

Company Information

Headquartered in Smithfield, Virginia, since 1936, Smithfield Foods, Inc. is an American food company with a leading position in packaged meats and fresh pork products. With a diverse brand portfolio and strong relationships with U.S. farmers and customers, we responsibly meet demand for quality protein around the world. For more information, visit www.smithfieldfoods.com. We believe in the power of protein to end food insecurity and have donated hundreds of millions of food servings to our communities. Smithfield boasts a portfolio of high-quality iconic brands, such as Smithfield, Eckrich and Nathan's Famous, among many others. For more information, visit www.smithfieldfoods.com and connect with us on Facebook, X, formerly known as Twitter, LinkedIn, and Instagram.