Quality Assurance Associate
$45,000–$60,000 year
HybridNewtown, Pennsylvania, United States
Job Summary
Review and approve GxP-regulated documents, including study protocols, validation reports, and change controls, to ensure compliance with regulatory requirements and internal standards. Conduct audits of study binders and quality records to verify completeness, traceability, and inspection readiness. Partner with laboratory and operations teams to facilitate document review processes, support customer and regulatory audits by coordinating responses and tracking requests, and manage corrective and preventive action (CAPA) follow-up activities. Develop procedures, work instructions, and job aids to strengthen quality systems and continuous improvement initiatives. Collaborate with global team members to maintain quality system effectiveness.
Required Qualifications
- Bachelor's degree in Biology, Chemistry, Biochemistry, Pharmaceutical Sciences, Life Sciences, or a related scientific discipline
- 0 to 2 years of experience in Quality Assurance, laboratory, lab operations, pharmaceutical, biotechnology, CRO, or other regulated environments
- Internship, co-op, undergraduate research, or laboratory experience in a regulated setting
- Must have excellent Microsoft Office skills (MS Word, Excel, PowerPoint, One Note, etc.)
- Basic understanding of GxP requirements, Good Documentation Practices (GDP), and ALCOA+ data integrity principles
- PMP certification or certifications from the American Society for Quality (ASQ) or similar professional organizations
- Strong attention to detail with the ability to review technical and scientific documentation for accuracy, completeness, and consistency
- Must be willing to accommodate multiple time zone including some early morning starts in order to work with the team in Germany
- Must be available on site for audits in Newtown, PA during regular business hours
- Approximately 5-10% domestic or international travel required for mandatory site meetings and trainings
Desired Qualifications
- Experience supporting audits, document control activities, or quality systems is a plus
- Recent graduates with relevant coursework and laboratory experience
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.