Quality Engineer

United Consulting Hub; New Jersey; On-site; USD 70,000 - 90,000; Full time

Job summary

United Consulting Hub in New Jersey seeks a detail-oriented Quality Engineer to support quality systems, regulatory compliance, and continuous improvement in a regulated pharma environment.

This role is suitable for recent graduates or early-career professionals interested in QA, compliance, validation, and quality systems, with cross-functional collaboration across Manufacturing, QC, R&D, and related teams to resolve quality issues.

Qualifications

• Basic understanding of QMS and pharma quality processes.
• Familiarity with 21 CFR Part 11, GMP, and quality standards.
• Knowledge of deviation management, CAPA, change control, and root-cause analysis.
• Strong analytical, problem-solving, and attention to detail.
• Good written and verbal communication with cross-functional teams.
• Proficiency in Microsoft Office, especially Excel and Word.
• Ability to organize tasks and follow established procedures.

Responsibilities

• Support implementation and ongoing improvement of Quality Management Systems (QMS).
• Assist in GMP compliance and adherence to quality standards.
• Support deviation reporting, investigations, root cause analysis and documentation.
• Participate in CAPA development, tracking and effectiveness checks.
• Review batch manufacturing records, controlled documents, and quality records.
• Assist with internal, customer, and regulatory audits preparation and coordination.
• Collaborate with Manufacturing, QC, R&D, and cross-functional teams to resolve quality issues.
• Support process validation and equipment qualification activities.
• Maintain records in accordance with GDP and procedures.
• Track and analyze quality metrics such as deviations, CAPAs, complaints.
• Support change control and assess impacts on quality/compliance.

Skills

QMS knowledge

Regulatory awareness

CAPA & deviation

Analytical skills

Communication skills

MS Office (Excel/Word)

Tools

Excel

Word

Job description

We are seeking a detail-oriented Quality Engineer to support quality systems, regulatory compliance, and continuous improvement activities within a regulated pharmaceutical or life sciences environment. This role is well suited for recent graduates or early-career professionals interested in Quality Assurance (QA), compliance, validation, and quality systems.

Key Responsibilities:

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

Skills Required:

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