Entry Level Quality Engineer
2 - 5 years
United States
Contract
Remote
1 month ago
About the role
Role: Junior Quality Engineer
Industry: Pharma and Life Sciences
Location: Remote
Experience: 0-2 years
Job Summary
Supports quality assurance and compliance activities to ensure pharmaceutical products meet regulatory standards set by FDA and WHO.
Key Responsibilities:Quality Assurance
Monitor manufacturing activities to ensure compliance with GMP
Assist in batch record review and release support
Quality Systems
Support deviations, CAPA (Corrective and Preventive Actions), and change control processes
Participate in root cause analysis and risk assessments
Documentation
Prepare and review SOPs, quality reports, and records
Ensure data integrity using ALCOA+ principles
Validation & Compliance
Support validation/qualification activities (IQ, OQ, PQ)
Follow 21 CFR Part 11 and GAMP 5
Audits & Inspections
Assist in internal/external audits and regulatory inspections
Ensure timely closure of audit observations
Skills Required:
Basic knowledge of GMP and quality systems
Strong documentation and analytical skills
Attention to detail and problem-solving ability
Industry: Pharma and Life Sciences
Location: Remote
Experience: 0-2 years
Job Summary
Supports quality assurance and compliance activities to ensure pharmaceutical products meet regulatory standards set by FDA and WHO.
Key Responsibilities:Quality Assurance
Monitor manufacturing activities to ensure compliance with GMP
Assist in batch record review and release support
Quality Systems
Support deviations, CAPA (Corrective and Preventive Actions), and change control processes
Participate in root cause analysis and risk assessments
Documentation
Prepare and review SOPs, quality reports, and records
Ensure data integrity using ALCOA+ principles
Validation & Compliance
Support validation/qualification activities (IQ, OQ, PQ)
Follow 21 CFR Part 11 and GAMP 5
Audits & Inspections
Assist in internal/external audits and regulatory inspections
Ensure timely closure of audit observations
Skills Required:
Basic knowledge of GMP and quality systems
Strong documentation and analytical skills
Attention to detail and problem-solving ability
Skills
Quality Assurance