Company Description
QRC Group, LLC is a firm dedicated to offer services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields.
Log on now to our website http://www.qrcgroup.com/ to learn more about our services and solutions!
Job Description

JOB SUMMARY:

Quality Systems Documentation Specialist to support and enhance our organization’s quality management systems. This role is responsible for ensuring compliance with internal policies, industry standards, and regulatory requirements. The ideal candidate will have experience in quality assurance, document control, and continuous improvement initiatives.

QUALIFICATIONS

• Bachelor’s degree in a relevant field (e.g., Engineering, Sciences, Quality Management).
• 5+ years of experience in quality systems or quality assurance.
• Proficiency in document management tools. (Ex. Master Control, TrackWise, Veeva).
• Knowledge of regulatory requirements and industry standards.
• Strong analytical, organizational, and communication skills.
• Proven experience in technical writing within regulated industries (Medical Devices, Pharma, Biotech).
• Technical writing
• Bilingual (Spanish/English)(Read/Speak)
  Additional Information
  All your information will be kept confidential according to EEO guidelines

• Maintain and improve the Quality Management System (QMS) in accordance with applicable standards (e.g., ISO 9001, ISO 13485, GMP).
• Manage document control processes, including creation, revision, approval, and archiving of quality documentation as VPM, URS, IQ/OQ/PQ, FAT/SAT and UAT (Document consolidation).
• Support internal and external audits, including preparation, execution, and follow-up on corrective actions.
• Monitor and report on quality metrics and performance indicators.
• Facilitate root cause analysis and corrective/preventive actions (CAPA).
• Collaborate with cross-functional teams to ensure quality standards are met throughout all processes.
• Provide training and support on quality system procedures and best practices.