Open role
[Remote] Quality Engineer
Note: The job is a remote job and is open to candidates in USA. United Consulting Hub is 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.
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
- 0-2 years of experience
- Detail-oriented
- 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.)
- Basic understanding of Quality Management Systems (QMS)
- Familiarity with deviation, CAPA, and change control processes
- Strong analytical and problem-solving skills
- Good documentation and communication skills
- Proficiency in MS Office (Excel, Word)
- Knowledge of regulatory requirements like 21 CFR Part 11
Company Overview
Company H1B Sponsorship