This role will involve leading various quality assurance activities, including CAPA, risk management, change control, and ensuring quality for FDA-regulated products and supporting manufacturing processes, manage post-market product support, and drive continuous improvement initiatives.
Responsibilities:
Ensure compliance with internal SOPs and external standards.
Lead Corrective and Preventive Action (CAPA), Risk Management, Risk Reviews, and change control processes.
Provide quality assurance and control for FDA-regulated products, including incoming materials and final release testing.
Maintain standards for client's Product Manufacturing, including raw material standards, product inspection, and test method maintenance.
Support Outsourced Manufacturing by developing quality plans, commercial supplier standards, Certificate of Analysis (CoAs), Supplier Corrective Action Requests (SCARs), and Drug Product Batch Record Reviews.
Lead post-market product support activities, including complaint analysis/trending, stability studies, and risk management updates.
Conduct investigations, develop corrective action responses, and monitor nonconforming materials, complaints, risk reviews, and supplier issues.
Collaborate with plant manufacturing locations and suppliers to ensure quality standards are met.
Drive quality initiatives and continuous improvement efforts across the organization.
Skills and Expertise:
Bachelor's degree or higher in a relevant field from an accredited institution.
Preferred degrees include Manufacturing/Industrial Engineering, Chemical Engineering, Mechanical Engineering, Statistics/Mathematics, or related disciplines.
Previous experience in an FDA-regulated device or drug environment is advantageous.
Purification and Filtration.
Proficiency in root cause analysis tools and techniques.
Demonstrated expertise in statistical and quality engineering tools such as exploratory data analysis, basic statistics, Gage R&R, Analysis of Variance, Failure Modes and Effects Analysis, Statistical Process Control and Capability, acceptance sampling, correlation and regression, and experimental design.
Certification such as American Society for Quality, Certified Quality Engineer (CQE), or willingness to obtain.