Job Description

Contemporary Staffing Solutions is seeking a QA Specialist to join our client to ensure quality, compliance, and patient safety within a pharmaceutical production environment. This role will oversee quality assurance systems and processes to maintain FDA 503B compliance, support sterile drug compounding operations, and uphold the highest standards of product integrity. The QA Specialist will play a key role in maintaining inspection readiness, driving continuous improvement, and fostering a culture of compliance across all departments.

Compensation:

$28$35/hour

Work Schedule:

Monday through Friday, onsite in Exton, PA

Key Responsibilities of the QA Specialist:

• Ensure Regulatory Compliance: Maintain adherence to FDA 503B outsourcing regulations, USP <795> , <797> , and <800> standards, and applicable DEA and state Board of Pharmacy requirements.
• Oversee Quality Systems: Develop, implement, and manage standard operating procedures (SOPs) and documentation supporting the Quality Management System (QMS), validation protocols, and controlled records.
• Audit and Inspection Readiness: Conduct internal and vendor audits, manage supplier corrective actions, and ensure preparedness for FDA and third-party inspections.
• Investigate and Prevent Issues: Lead deviation investigations, root cause analyses, and corrective/preventive actions (CAPAs) to ensure timely resolution and continuous improvement.
• Support Production Quality: Review batch records, oversee calibration and maintenance activities, and verify testing results to confirm product sterility, potency, and safety.
• Train and Collaborate: Provide guidance and training to employees on policies, aseptic techniques, GMP/GDP, and other quality topics to reinforce compliance and accountability.

Qualifications and Skills for the QA Specialist:

• Bachelors degree in a scientific discipline or equivalent experience in pharmaceutical quality assurance.
• Strong understanding of FDA, USP, GMP, and QMS principles within a sterile compounding or manufacturing environment.
• Excellent attention to detail, organizational, and time management skills with the ability to meet critical deadlines.
• Skilled in troubleshooting, problem-solving, and implementing effective CAPAs.
• Strong written and verbal communication skills with the ability to train and influence others across teams.
• Proficient in maintaining audit documentation and compliance metrics; prior experience with validation activities preferred.

Why Join Us?

This is an exciting opportunity to be part of a growing organization that prioritizes innovation, collaboration, and excellence in patient safety. As a valued member of the team, youll gain hands-on exposure to regulatory compliance, validation projects, and continuous improvement initiatives that shape the future of pharmaceutical quality operations.

About Us:

Contemporary Staffing Solutions (CSS) is a trusted leader in providing contract, temporary, temp-to-hire, and direct hire staffing solutions. With decades of experience, weve grown from a staffing agency to a nationwide provider of workforce management solutions. Our niche recruitment expertise spans Accounting & Finance, Call Center & Office Support, Human Resources, Sales & Marketing, and Information Technology.

Explore more about CSS and how we connect great talent with exceptional opportunities by visiting

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