Quality Assurance Technician

Quality Control SpecialistEducation Required: High School Diploma or Equivalent required. Position Requirements: Minimum 2 years of quality control, quality assurance, or documentation review experience in a regulated manufacturing environment. Experience working in a controlled industry such as medical devices, pharmaceuticals, biotechnology, or food manufacturing. Experience reviewing production records, Device History Records (DHRs), batch records, or other controlled manufacturing documentation. Knowledge of Good Documentation Practices (GDP) and accurate record review. Ability to identify documentation discrepancies and coordinate corrections with production supervisors or cross-functional teams. Strong attention to detail with the ability to follow established procedures and quality standards. Excellent written and verbal communication skills with a professional approach to issue resolution. Ability to escalate quality or documentation concerns in a timely manner. Basic computer skills for reviewing and maintaining electronic quality records. Ability to work independently while contributing to a positive, team-oriented environment. Self-motivated, proactive, and dependable with a strong work ethic. Willingness to work the scheduled shift Monday–Thursday, 5:00 AM–3:30 PM, with occasional overtime as needed. Experience Preferred: Experience working in a medical device, pharmaceutical, biotechnology, food, or other regulated manufacturing environment. Previous experience with quality control (QC), quality assurance (QA), or inspection activities. Experience reviewing Device History Records (DHRs), batch records, travelers, work orders, or controlled manufacturing documentation. Knowledge and practical application of Good Documentation Practices (GDP). Experience identifying documentation errors, initiating corrections, and ensuring records meet compliance requirements. Job Summary: Supports quality control and quality assurance operations within a regulated manufacturing environment. Reviews production records, Device History Records (DHRs), and quality documentation to ensure completeness, accuracy, and compliance with established procedures. Performs quality inspections, including microscope-based inspections when required, to verify product quality and workmanship. Collects, evaluates, and documents quality data to support quality assurance activities and process improvements. Works closely with engineers, production teams, and supervisors to resolve documentation discrepancies and quality issues. Ensures compliance with Good Documentation Practices (GDP), company procedures, and regulatory requirements. Assists with quality investigations, testing activities, and continuous improvement initiatives. Maintains accurate quality records while following defined procedures and work instructions. Communicates professionally with cross-functional teams regarding corrections, escalations, and quality concerns.