Quality Assurance Associate

Newtown Location
642 Newtown Yardley Rd
Newtown, PA 18940, USA

Newtown Location
642 Newtown Yardley Rd
Newtown, PA 18940, USA

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.

Position Summary:

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 ofglobalscientific, technical, and quality records to ensure they meet regulatory requirements, customer expectations, and internal quality standards.

The QA Associate will alsobe 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' missiontoimproving patient outcomes. The ideal candidate is detail-oriented, collaborative, and passionate about quality and compliance.

A Day in the Life of aQA Associate at Discovery Life Sciences:

• Review scientific, technical, and quality documentation to ensure compliance with GxP requirements, internal procedures, and industry standards.
• Partner with laboratory, operations, and quality teams tofacilitatetimelydocument review and approval processes.
• Support customer and regulatory audits by preparing documentation, tracking requests, andassistingwith audit logistics.
• Conduct audits of study binders and quality records to verify completeness, traceability, andinspectionreadiness.
• 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.

Must-Have Qualifications(Education, Skills, Experience):

• Bachelor's degree in Biology, Chemistry, Biochemistry, Pharmaceutical Sciences, Life Sciences, ora 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.

Key Responsibilities:

Document Review & Compliance

• 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 systemsremainfit for intended use andmaintainedin a validated state.
• Conduct audits of study binders and associated records to verify completeness, traceability, and audit readiness.
• Identify quality, compliance, anddocumentationissues and trends, providingtimelyfeedback and resolution support.

Audit Support

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