Quality Assurance Spec 1

This position requires the associate to be onsite in Mebane, NC, with no remote/hybrid option. The role is essential for maintaining quality assurance in a fast-paced, regulated environment.

Key Responsibilities

• Provide daily, hands-on quality support on Liquid Media production lines.
• Assist with line setup and line clearance activities as needed.
• Perform in-process quality checks and spot inspections to ensure adherence to procedures and specifications.
• Conduct real-time review of production documentation for accuracy, completeness, and legibility.
• Ensure compliance with GDP requirements and identify documentation errors for correction.
• Monitor and escalate recurring documentation issues to supervision for corrective action.
• Detect and document nonconforming conditions during production and inspection activities, and initiate containment actions.
• Perform preliminary fact gathering to support investigations.
• Escalate complex issues to Quality Engineers or appropriate technical functions.
• Support investigations through documentation review and data collection.
• Partner with Manufacturing, Engineering, Maintenance, and Product Support to resolve quality-related issues.
• Provide guidance to production associates on quality requirements and documentation expectations.
• Coordinate or assist with sample preparation and submission to the QC laboratory.
• Serve as the on-floor quality representative to ensure compliance with procedures and regulatory requirements.
• Promote awareness of quality standards, defect prevention, and GDP compliance.
• Escalate risks and quality concerns in a timely manner.

Skills

• Ability to assess the immediate quality impact of events observed on the production floor and support appropriate escalation, containment, and documentation in accordance with established procedures and quality system requirements.
• Sound independent judgment in identifying potential compliance or product quality concerns, prioritizing issues, and taking appropriate action within defined responsibilities while recognizing when escalation is needed.
• Strong working knowledge of Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP) in a regulated manufacturing environment.
• Attention to detail and ability to identify documentation errors, process deviations, and nonconforming conditions in real time.
• Effective communication and collaboration skills for working with Manufacturing, Quality Control, Engineering, Maintenance, and other cross-functional teams.
• Ability to perform documentation review and basic fact gathering to support investigations and issue resolution.
• Ability to work effectively in a fast-paced production environment while maintaining a high standard of compliance, accuracy, and responsiveness.

Required Qualifications

• Minimum of 2 years’ experience in manufacturing or quality in an FDA-regulated or ISO 13485 environment.
• Bachelor’s degree, or 4 years’ additional experience in manufacturing or quality.
• Basic knowledge of Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP).
• Experience with inspection, documentation review, or production support activities.
• Strong attention to detail and ability to identify errors and nonconformances.
• Ability to work independently and in a team environment in a fast-paced production setting.
• Effective communication skills for interaction with production and cross-functional teams.
• Basic computer proficiency (e.g., Microsoft Office).

Preferred Qualifications

• Familiarity with sampling plans and inspection standards.
• Experience supporting production floor quality activities.
• Basic understanding of nonconformance processes.

Work Environment and Physical Requirements

This position is primarily based on the production floor rather than in an office setting. The individual is expected to be present where manufacturing occurs, observing processes, responding to issues in real time, and collaborating directly with line personnel to improve quality performance. The role requires standing and walking for extended periods, use of personal protective equipment, and work within controlled manufacturing environments.