Quality Assurance Associate

About Discovery Life Sciences:

Discovery Life Sciences (Discovery) is a leading provider of highly characterized human biospecimens and cellular starting materials to advance cell and gene therapy and precision medicine programs for cancer, infectious disease, and other complex conditions. We routinely manage hundreds of studies and expertly test thousands of biospecimens simultaneously. Leading biopharma, diagnostic and academic institutions trust us to quickly deliver high-quality biospecimens and reliable, reproducible biomarker data, so they can outpace their competition and push the leading edge of innovation using our Science at your Service TM business model.

Discovery Life Sciences is seeking a Quality Assurance Associate to join our Global Quality & Regulatory team. This role plays a critical part in ensuring the integrity, accuracy, and compliance of laboratory and quality system documentation across Specialty Lab Services. Through the application of ALCOA+ data integrity principles, Good Documentation Practices (GDP), and risk-based quality methodologies, the Quality Assurance Associate will perform independent reviews of global scientific, technical, and quality records to ensure they meet regulatory requirements, customer expectations, and internal quality standards.

The QA Associate will also be providing local internal and external audit support at our Newtown, PA location.

This position offers an excellent opportunity for recent graduates or early-career professionals to gain meaningful experience in a regulated biotechnology environment while contributing directly to Discovery Life Sciences' mission to improving patient outcomes. The ideal candidate is detail-oriented, collaborative, and passionate about quality and compliance.

• Review scientific, technical, and quality documentation to ensure compliance with GxP requirements, internal procedures, and industry standards.
• Partner with laboratory, operations, and quality teams to facilitate timely document review and approval processes.
• Support customer and regulatory audits by preparing documentation, tracking requests, and assisting with audit logistics.
• Conduct audits of study binders and quality records to verify completeness, traceability, and inspection readiness.
• Assist with quality investigations, CAPA follow-up activities, and continuous improvement initiatives.
• Collaborate with global team members, including colleagues in Germany, to support quality system effectiveness and compliance.

• Bachelor's degree in Biology, Chemistry, Biochemistry, Pharmaceutical Sciences, Life Sciences, or a related scientific discipline. Related experience or degree fields may be considered.
• 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.
• Experience supporting audits, document control activities, or quality systems is a plus.
• 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.
• Recent graduates with relevant coursework and laboratory experience are encouraged to apply.

• Review and approve GxP-regulated documents for compliance, accuracy, completeness, and quality.
• Perform quality reviews of study protocols, protocol amendments, analytical plans, and bioanalytical reports.
• Review assay development reports, validation plans, and validation reports to ensure compliance with regulatory and internal requirements.
• Assess change controls and risk management documentation for appropriate impact assessment, implementation, and documentation.
• Review computerized system validation documents to ensure systems remain fit for intended use and maintained in a validated state.
• Conduct audits of study binders and associated records to verify completeness, traceability, and audit readiness.
• Identify quality, compliance, and documentation issues and trends, providing timely feedback and resolution support.

• Assist with pre-audit preparation and documentation requests.
• Support customer, client, and regulatory audits by documenting requests, retrieving records, coordinating responses, and facilitating audit activities.
• Provide post-audit support, including documentation of findings and review of audit responses where applicable.
• Track corrective and preventive actions (CAPAs) through completion and closure.