Quality Systems Specialist - UP 3500, Ubi, Perm

Quality Systems Specialist - UP 3500, Ubi, Perm

Job Scope

Ensure site compliance with all federal, state, local, and corporate regulations to prevent business interruptions.

Conduct compliance assessments of site quality systems through process, facility, and equipment inspections.

Review SOPs, protocols, batch records, and quality records for technical accuracy and regulatory compliance.

Prepare study and QA files for client site visits and regulatory inspections and provide support during these events.

Perform internal facility inspections and maintain all associated audit records and reports for management.

Review facility and equipment records, logbooks, and approve customer test reports to support lab operations.

Participate in audits of subcontractors, vendors, and suppliers to ensure quality of products and services.

Assist in collecting and analyzing site quality metrics and preparing data for Quality Management Review.

Identify and communicate recommendations for corrective actions and improvements to operational quality systems.

Provide basic regulatory training to operations personnel and respond to customer qualification inquiries.

Requirements

Bachelor's degree (B.S. / BA.A.) or equivalent, preferably in a life science.

Minimum of 2 years in a Quality Assurance role.

May occasionally be required to wear protective clothing and equipment.

Interested applicants, please send your resume to or click here to apply now. All applications will be treated with strictest confidentiality. We regret that only shortlisted candidates will be notified. Thank you.

#J-18808-Ljbffr