Quality Assurance Specialist

Job Title: Quality Assurance Specialist
Location: Exton, PA
Hours/Schedule: Monday-Friday, 8:00AM-5:00PM
Type: 6-Month, Contract-to-Hire

Overview
We're looking for a Quality Assurance Specialist ready to make an impact at a fast-growing sterile drug manufacturer in Exton, PA. This is an excellent opportunity for an experienced QA professional who enjoys rolling up your sleeves, driving compliance improvements, and jumping in wherever needed. You'll be part of a small, agile team in a 503B compounding environment where your ideas, initiative, and cross-functional mindset will directly shape the company's success.

Responsibilities

• Drive improvements to the Quality Management System by introducing new ideas to enhance efficiency, compliance, and inspection readiness
• Create, revise, and maintain SOPs and other controlled documents to ensure alignment with FDA, USP, and GMP standards
• Support QC operations as needed, including environmental monitoring, cleanroom activities, and batch documentation
• Review and approve deviations, CAPAs, investigations, and change controls to ensure timely resolution and compliance
• Assist with validation activities for processes, products, and equipment in support of manufacturing and quality goals
• Conduct and support internal and supplier audits, maintaining accurate records and implementing corrective actions
• Participate in regulatory and customer inspections and help maintain a state of continuous inspection readiness
• Collaborate across departments on compliance activities such as product recalls, complaint investigations, and state licensure renewals
• Track and trend quality metrics to identify process improvements and support management review meetings

Requirements

• Bachelor's degree in a scientific discipline
• 5+ years of Quality Assurance experience within a GMP manufacturing environment
• Prior experience in a 503B compounding facility - required
• Demonstrated knowledge of QMS implementation and regulatory frameworks (21 CFR Part 11, 210, 211)
• Experience with SOP creation, modification, and document control
• Ability and willingness to support cleanroom operations and QC functions as needed
• Proven ability to work independently and cross-functionally in a small, fast-paced start-up team
• Must be legally authorized to work in the United States for any employer

Benefits
System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan

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Ref: #558-Scientific