Quality Assurance Associate

Job Details

1st Employment is seeking a detail-oriented Quality Assurance Associate for our client in Rogers, AR. This position plays a critical role in maintaining quality systems, document control, and regulatory compliance within a manufacturing environment. The Quality Assurance Associate is responsible for the review, approval, retention, organization, and retrieval of quality documentation, including Batch History Records (BHRs), while ensuring compliance with company standards and applicable regulatory requirements.

The ideal candidate will have experience in quality assurance, document control, or quality systems management within an ISO, FDA, USDA, or similarly regulated manufacturing environment. The Quality Assurance Associate will work closely with Quality Systems personnel, Production teams, suppliers, and customers to support product quality, material release processes, audits, investigations, and continuous improvement initiatives.

This position is considered safety-sensitive and requires strict adherence to established quality standards, safety procedures, and regulatory requirements.

Key Responsibilities

Document Control & Records Management

• Review Batch History Records (BHRs) for completeness, accuracy, traceability, and compliance with approved procedures
• Maintain, organize, and control quality system documentation
• Develop and maintain filing and indexing systems for secure and efficient document retrieval
• Follow up with internal departments regarding documentation corrections and discrepancies
• Ensure proper retention and retrieval of quality records

Quality Systems Support

• Participate in internal audits and quality system reviews
• Support investigations related to customer complaints, non-conformances, and corrective and preventive actions (CAPAs)
• Assist in maintaining compliance with ISO standards, GMP requirements, and internal quality procedures
• Promote continuous improvement initiatives throughout the organization

Material and Product Release

• Review and release incoming raw materials following inspection requirements
• Release materials for production use after quality verification
• Review and release work-in-process (WIP) and finished goods following documentation review
• Support product release activities while ensuring compliance with quality standards

Supplier and Procurement Support

• Assist with supplier qualification documentation and approved supplier records
• Support vendor-related quality activities in accordance with established procedures
• Maintain supplier documentation and quality records

Equipment Documentation

• File, maintain, and organize calibration records and equipment-related documentation

Change Control and Process Improvement

• Initiate and support minor procedural changes within Quality Systems and Production
• Participate in approved change control processes
• Support continuous improvement and quality enhancement efforts

Customer Support

• Respond to customer requests for information, including Certificates of Analysis (COAs), supplier evaluations, and other quality-related documentation

Professional Responsibilities

• Maintain current knowledge of quality standards, regulations, and industry best practices
• Demonstrate excellent attendance, punctuality, and reliability
• Perform additional duties as assigned

Qualifications

Education and Experience

• High School Diploma or GED required
• Minimum of five (5) years of Quality Assurance, Quality Systems, or Document Control experience in a regulated manufacturing environment
• Experience working within ISO, FDA, USDA, or similar regulated industries preferred
• Experience with biological production environments is a plus

Knowledge, Skills, and Abilities

• Strong understanding of quality assurance principles and document control practices
• Knowledge of records management and regulatory compliance requirements
• Familiarity with ISO 9001, Good Manufacturing Practices (GMP), and quality management systems
• Knowledge of OSHA, USDA, and FSIS regulations and requirements
• Proficiency in Microsoft Office Suite
• Excellent organizational and documentation skills
• Strong written and verbal communication abilities
• Ability to manage multiple priorities and meet deadlines
• Meticulous attention to detail and accuracy
• Strong problem-solving and analytical skills
• Ability to work independently and collaboratively within a team environment

Mathematical Skills

• Ability to calculate percentages, ratios, proportions, fractions, area, and volume
• Ability to perform basic statistical analysis and interpret quality-related data

Work Environment

• Manufacturing and quality-controlled production environment
• Frequent interaction with production, quality, and management personnel
• Must comply with all safety, quality, and regulatory requirements