Quality Engineer

United Consulting Hub; New York (NY); On-site; USD 65,000 - 90,000; Full time

Job summary

United Consulting Hub, Inc. is seeking a detail-oriented Quality Engineer to support quality systems, compliance, and continuous improvement initiatives in a regulated pharmaceutical or life sciences environment.

This role is ideal for recent graduates interested in QA, compliance, and validation.

You will assist in deviation handling, CAPA, review batch records, and participate in audits while collaborating with production, QC, and R&D teams.

Qualifications

• Basic understanding of Quality Management Systems (QMS).
• Familiarity with 21 CFR Part 11 preferred.
• Experience or exposure to deviation handling, CAPA, and change control.
• Strong analytical and problem-solving skills.
• Good documentation and communication abilities.

Responsibilities

• Support implementation and maintenance of Quality Management Systems (QMS).
• Ensure compliance with Good Manufacturing Practices and company standards.
• Assist in deviation handling, investigations, and root cause analysis.
• Participate in CAPA (Corrective and Preventive Actions) activities.
• Review batch manufacturing records and quality documentation.
• Support internal and external audits (regulatory/customer).
• Collaborate with production, QC, and R&D teams.
• Assist in process validation and qualification documentation.
• Maintain proper documentation aligned with Good Documentation Practices.
• Track and analyze quality metrics (deviations, complaints, etc.).

Skills

Quality Management Systems (QMS)

21 CFR Part 11

Deviation management

CAPA & change control

Analytical thinking

Documentation & communication

Job description

We are looking for a detail-oriented Quality Engineer to support quality systems, compliance, and continuous improvement initiatives in a regulated pharmaceutical or life sciences environment. This role is ideal for recent graduates interested in Quality Assurance (QA), Compliance, and Validation.

Key Responsibilities:

• Support implementation and maintenance of Quality Management Systems (QMS)
• Ensure compliance with Good Manufacturing Practices and company standards
• Assist in deviation handling, investigations, and root cause analysis
• Participate in CAPA (Corrective and Preventive Actions) activities
• Review batch manufacturing records and quality documentation
• Support internal and external audits (regulatory/customer)
• Collaborate with production, QC, and R&D teams
• Assist in process validation and qualification documentation
• Maintain proper documentation aligned with Good Documentation Practices
• Track and analyze quality metrics (deviations, complaints, etc.)

Skills Required:

• Basic understanding of Quality Management Systems (QMS)
• Knowledge of regulatory requirements like 21 CFR Part 11 (preferred)
• Familiarity with deviation, CAPA, and change control processes
• Strong analytical and problem-solving skills
• Good documentation and communication skills