QA Systems Associate-Bioscience

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.

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.

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.

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.

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…