Quality Assurance Specialist

Our esteemed client in Chester County, PA is seeking a Quality Assurance Associate to join their organization. This role will support the execution of QA initiatives and ensure compliance with current Good Documentation Practices (GDP), CAPA processes, change control procedures, and the development and maintenance of quality systems. This position plays a vital role in promoting a culture of quality across the organization. The QA Associate will work collaboratively with internal teams and external vendors but does not have direct line management responsibilities.

Key Responsibilities

Promote and uphold a strong culture of quality and compliance across all departments.

Conduct training sessions on quality topics for internal staff and external vendors.

Support the CAPA system, including drafting deviation reports, conducting investigations, and performing effectiveness checks.

Assist in the development and maintenance of QA systems and controlled documentation, including audits, vendor qualifications, and change control using Quality Management System (QMS).

Contribute to the establishment of QA oversight for Clinical Trial Distribution (CTD) and logistics processes, including occasional travel for audits or inspections.

Draft, review, and manage Standard Operating Procedures (SOPs) and related quality documentation.

Stay informed on local and international regulatory requirements and ensure organizational compliance.

Participate in quality audits, inspections, and continuous improvement initiatives.

Qualifications

1+ year of experience in a Quality Assurance role or within a GMP-regulated pharmaceutical or life sciences environment

Familiarity with GDP, GMP, and regulatory compliance requirements

Strong knowledge of quality systems, compliance standards, and regulatory guidelines

Excellent verbal and written communication skills with a focus on customer service and collaboration

Ability to work independently and manage multiple tasks in a fast-paced environment

Strong organizational and time management skills with attention to detail

Experience with validation, qualification processes, and regulatory submissions is a plus

Lean Six Sigma knowledge or certification is desirable

Ascendo is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability