Quality Specialist

Job Description

Job Description

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 (Remote)
* 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+ 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