Derived from job-description analysis by Serendipath's career intelligence engine.
Original posting from Brillfy Technology Inc
Job Title:
GMP Quality Engineer / Quality Systems Engineer
Client:
Avantor
Location:
Phillipsburg, NJ
Work Type:
Onsite (M-F)
Duration:
18 Months Contract-to-Hire
Job Summary:
Seeking a Quality Engineer with strong GMP manufacturing experience to support quality systems, compliance programs, audits, CAPA, investigations, and validation activities for a leading life sciences manufacturing environment.
Must Have:
- 5+ years of Quality Engineering / QA experience
- Experience in pharmaceutical, biotech, or chemical manufacturing
- Strong understanding of:
- cGMP
- FDA regulations
- ISO 9000
- CAPA
- Validation
- Complaint investigations
- Bachelor’s degree in Chemistry or related Science field
Key Responsibilities:
- Lead quality assurance and compliance activities
- Manage CAPA and corrective actions
- Support customer, GMP, ISO, and internal audits
- Conduct investigations and root cause analysis
- Support validation and process improvement efforts
- Ensure ongoing regulatory compliance
Preferred:
- Stability/SPC experience
- Supplier quality experience
- ICHQ7/IPEC knowledge
- Strong documentation and communication skills
Interview Process:
- 15-minute Teams interview
- 2-hour onsite interview
Work Environment:
- GMP manufacturing facility
- PPE required
- Occasional domestic travel possible
Source: Brillfy Technology Inc careers