[Remote] Quality Engineer

Note: The job is a remote job and is open to candidates in USA. United Consulting Hub is seeking a detail-oriented Quality Engineer to support quality systems, regulatory compliance, and continuous improvement in a regulated pharmaceutical or life sciences environment. The role focuses on quality assurance, deviation and CAPA management, audits, validation, documentation, and cross-functional quality issue resolution.

Responsibilities

• Support the implementation, maintenance, and improvement of Quality Management Systems (QMS)
• Assist in ensuring compliance with Good Manufacturing Practices (GMP) and applicable company quality standards
• Support deviation management, investigations, root cause analysis, and documentation of quality events
• Participate in CAPA (Corrective and Preventive Action) activities, including tracking and effectiveness monitoring
• Review batch records, controlled documents, procedures, and other quality documentation for accuracy and completeness
• Assist with preparation and support of internal, customer, and regulatory audits
• Collaborate with Manufacturing, Quality Control (QC), R&D, Engineering, and other cross-functional teams to resolve quality issues
• Support process validation, equipment qualification, and related quality documentation activities
• Maintain accurate records in accordance with Good Documentation Practices (GDP) and approved procedures
• Track and analyze quality metrics such as deviations, CAPAs, complaints, and other quality indicators
• Assist with change control activities and assess potential quality and compliance impacts

Skills

• Basic understanding of Quality Management Systems (QMS) and pharmaceutical quality processes
• Familiarity with deviation management, CAPA, change control, and root cause analysis
• Strong analytical, problem-solving, organizational, and attention-to-detail skills
• Good written and verbal communication skills with the ability to work effectively in cross-functional teams
• Proficiency in Microsoft Office , particularly Excel and Word
• Knowledge of regulatory requirements such as 21 CFR Part 11 , GMP, and applicable quality standards is preferred

Benefits

• Remote work arrangement

Company Overview

Company H1B Sponsorship