QA Specialist
Biopharmaceutical
ExtonPennsylvania Contract Dec 4, 2025

Job Title: QA Specialist

Job Overview:
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 developing and managing quality documentation, reviewing deviations and CAPA plans, supporting validation protocols, and maintaining inspection readiness.

Compensation:
$28–$35/hour

Work Schedule:
Monday through Friday, onsite in Exton, PA

Key Responsibilities of the QA Specialist:

  • Create, edit, and standardize SOPs, QMS documents, validation protocols, and other quality-related materials to ensure consistent compliance with regulatory requirements.
  • Evaluate deviations, CAPA plans, and change controls to ensure thorough documentation, proper corrective actions, and timely resolution of quality issues.
  • Assist with validation protocols, perform audit-related documentation, and contribute to regulatory submissions and inspection readiness.
  • Lead investigations, draft investigation reports, and participate in root cause analyses to support continuous improvement initiatives and risk mitigation.
  • Provide guidance and training to staff on quality processes, documentation standards, and compliance best practices to reinforce organizational quality culture.

Qualifications and Skills for the QA Specialist:

  • Bachelor’s degree in a scientific discipline or equivalent experience in pharmaceutical quality assurance.
  • Strong knowledge of FDA, USP, GMP, and QMS principles within a sterile compounding or manufacturing environment.
  • Proven experience in SOP development, QMS documentation, and quality document standardization.
  • Skilled in reviewing and approving deviations, CAPA plans, and change controls, and in writing investigation reports.
  • Excellent attention to detail, organizational, and time management skills, with the ability to meet critical deadlines.
  • Strong written and verbal communication skills; capable of training and influencing cross-functional teams.
  • Familiarity with validation protocols, audit documentation, and regulatory writing is highly 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, you’ll 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, we’ve 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 www.ContemporaryStaffing.com.