GMP Quality Engineer - Compliance & Continuous Improvement
Harba5 months ago
Indianapolis, IN, United States
Hybrid
Full-time
Junior Level (1-3 years)
Job Description
Job Responsibilities:
- Support and maintain quality systems to ensure compliance with cGMP regulations, FDA requirements, and internal quality standards
- Collaborate with Manufacturing, Engineering, Validation, and Regulatory teams to support quality and compliance initiatives
- Investigate deviations, non-conformances, customer complaints, and quality events to determine root cause and implement corrective actions
- Lead and support CAPA activities to improve manufacturing processes and prevent recurring quality issues
- Review and approve manufacturing documentation including batch records, SOPs, protocols, and technical reports
- Perform risk assessments and participate in Process Failure Mode and Effects Analysis (FMEA) activities to identify and mitigate process risks
- Monitor manufacturing processes and quality metrics to identify trends and drive continuous improvement initiatives
- Support internal audits, supplier audits, customer audits, and regulatory inspections
- Ensure data integrity and accuracy of quality documentation, records, and electronic systems
- Assist with validation and qualification activities including process validation, equipment qualification, and cleaning validation reviews
- Support change control processes by evaluating the impact of proposed changes on product quality and regulatory compliance
- Partner with cross-functional teams to implement process improvements and enhance product quality and operational efficiency
- Develop and maintain quality procedures, work instructions, and compliance documentation
- Provide quality oversight and support for manufacturing operations in fast-paced GMP environments
- Promote a culture of quality, compliance, accountability, and continuous improvement throughout the organization
Qualifications:
- Bachelor’s degree in Engineering, Life Sciences, Chemistry, or related technical field
- 3+ years of experience in pharmaceutical, biologics, medical device, or GMP-regulated manufacturing environments
- Strong knowledge of cGMP regulations, FDA requirements, and pharmaceutical quality systems
- Experience with deviation investigations, CAPA systems, change controls, and quality risk management
- Familiarity with process validation, equipment qualification, and manufacturing operations preferred
- Understanding of aseptic processing, sterile manufacturing, or pharmaceutical production operations preferred
- Experience supporting audits, inspections, and regulatory compliance activities
- Strong analytical, troubleshooting, and problem-solving skills
- Excellent technical writing, documentation, and communication abilities
- Knowledge of risk management tools such as FMEA preferred
- Lean Six Sigma certification or continuous improvement experience preferred
- Ability to manage multiple priorities and work effectively in cross-functional teams
- Proficiency with Microsoft Office, quality systems, and electronic documentation systems preferred
- Strong attention to detail and commitment to maintaining high-quality standards
Required Skills
cGMP regulations
pharmaceutical quality systems
analytical skills
deviation investigations
process validation
technical writing
equipment qualification
Microsoft Office
quality risk management
change controls
CAPA systems
electronic documentation systems
FDA requirements
LEAN Six Sigma