Quality Specialist
VA, US
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 Monday–Friday 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: Monday–Friday, 8:00 AM–4:30 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.
• 3–5+ 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 1300–1317)
• FDA Regulations and Good Distribution Practices (GDP)
• Document Control and Training Management Systems
• MasterControl or similar electronic QMS platforms
• Job Title: Quality Specialist
• Location: Remote
• Type: 6-month assignment
• Pay: $35 – $45 per hour
• Schedule: Monday–Friday, 8:00 AM–4:30 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.
• 3–5+ 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 1300–1317)
• FDA Regulations and Good Distribution Practices (GDP)
• Document Control and Training Management Systems
• MasterControl or similar electronic QMS platforms