QA System Associate-Bioscience

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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.

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.

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.

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.