NEW JOB OPENING
QUALITY ASSURANCE SPECIALIST - FDA MANUFACTURING
IN Mebane, NC, USA!

Required Education:

• Bachelor’s degree, or High School with 4 years’ additional experience in manufacturing or quality assurance



Required Skills and Experience:

• Minimum of 2 years’ experience in manufacturing or quality in an FDA-regulated or ISO 13485 environment

• 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)

• 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



Preferred Skills and Experience:

• Familiarity with sampling plans and inspection standards

• Experience supporting production floor quality activities

• Basic understanding of nonconformance processes



Responsibilities:

• Provide daily, hands-on quality support on Liquid Media production lines

• Assist as needed to verify line setup and line clearance activities

• 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

• **Only those lawfully authorized to work in the designated country associated with the position will be considered.**

• **Please note that all Position start dates and duration are estimates and may be reduced or lengthened based upon a client’s business needs and requirements.**