CornerStone Professional Placement is seeking a Quality Specialist for a leading Pharmaceutical company. We are looking for a Quality Specialist to support quality excellence in a regulated healthcare distribution environment. This fully remote opportunity offers competitive pay, a consistent MondayFriday schedule, and the chance to make a meaningful impact on quality and compliance initiatives. The Quality Specialist must have a strong background in supplier quality, regulatory compliance, and Quality Management Systems (QMS).
Job Title: Quality Specialist
Location: Remote
Type: 6-month assignment
Pay: $35 $45 per hour
Schedule: MondayFriday, 8:00 AM4:30 PM CST
Responsibilities for the Quality Specialist
Manage supplier/customer quality questionnaires, supplier qualification, and Quality Agreements.
Develop and maintain SOPs, document control, training records, and QMS documentation.
Ensure compliance with FDA, DEA, ISO 13485, and audit readiness requirements.
Partner with cross-functional teams to support supplier quality, risk assessments, and continuous improvement initiatives.
Qualifications for the Quality Specialist
Bachelor's degree in a scientific, healthcare, quality-related field, or an equivalent combination of education and experience.
3+ years of experience in quality, compliance, supplier quality, or regulated distribution environments.
Working knowledge of supplier quality systems, FDA regulations, DEA requirements, quality documentation practices, and audit readiness principles.
Preferred Qualifications
Experience supporting Quality Agreement development, contract review, and supplier or customer audit activities.
Experience within pharmaceutical, medical device, healthcare distribution, or controlled substance environments.
ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or equivalent quality certification preferred.
Core Tools & Systems
Quality Management Systems (QMS)
Supplier Quality Management Programs
ISO 13485 Quality Management Standards
DEA Regulations (21 CFR Parts 13001317)
FDA Regulations and Good Distribution Practices (GDP)
Document Control and Training Management Systems
MasterControl or similar electronic QMS platforms