PSC Biotech® Corporation · 6 hours ago
Quality Engineer
Irvine, CA
Full-time
Onsite
Entry, Mid Level
$80K/yr - $110K/yrPSC Biotech® Corporation provides essential services to the life sciences sector, ensuring compliance with regulatory requirements. The Quality Engineer will monitor product quality, lead investigations into manufacturing issues, and implement corrective actions to maintain high standards in a regulated environment.
BiotechnologyEnterprise SoftwareConsultingAutomotiveLife ScienceProject ManagementQuality AssuranceRental
No H1B
Responsibilities
Monitor manufacturing and operational performance to proactively identify quality risks and improvement opportunities
Lead and participate in root cause investigations related to manufacturing failures, non-conformances, deviations, and customer complaints
Develop, implement, and track corrective and preventive actions (CAPAs) to ensure issues are effectively resolved and recurrence is prevented
Document investigation outcomes and ensure timely closure in accordance with quality system requirements
Design, implement, and maintain quality control systems, inspection criteria, and Standard Operating Procedures (SOPs) in alignment with regulatory and internal quality requirements
Support the development and continuous improvement of Quality Management System (QMS) elements, including deviations, CAPA, change control, and documentation practices
Ensure quality processes are audit-ready and support internal and external inspections as needed
Utilize Statistical Process Control (SPC) and other quality tools to analyze process data, identify trends and variations, and assess process capability
Collaborate with cross-functional teams to implement process improvements that enhance efficiency, reduce defects, and improve overall product quality
Qualification
Required
Bachelor's degree in Engineering, Life Sciences, or a related technical discipline
Experience working in a regulated biotech, pharmaceutical, or life sciences environment
Strong understanding of quality systems, GxP principles, and regulatory expectations (e.g., FDA, ISO, cGMP)
Hands-on experience with root cause analysis methodologies and CAPA management
Working knowledge of Statistical Process Control (SPC) and data-driven process improvement tools
Strong technical writing skills with experience developing SOPs and quality documentation
Excellent analytical, problem-solving, and cross-functional communication skills
Ability to work independently while effectively collaborating in a fast-paced, team-oriented environment
Must be authorized to work in the U.S
No C2C at this time
Benefits
Medical and sick time benefits
Company
PSC Biotech® Corporation
Founded in 1996, PSC Biotech Corporation was created with the vision of providing life science companies unmatched support.
Founded in 1996
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
John Clapham
CEO
Recent News
2025-12-18
2025-10-20
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