Quality Assurance Associate at Integral Molecular

<p>Integral Molecular is a close-knit, medium-sized biotech company focused on developing and applying innovative technologies that advance vaccines and antibody therapeutics targeting difficult proteins. Over the past year, we implemented and optimized an electronic Quality Management System to streamline the maintenance of our products and services at a consistent, high-quality standard.</p> <p>We are actively seeking a Quality Assurance Associate to own our Quality Management System (QMS), ensure compliance, drive data-informed improvements, and keep the company aligned with ISO 9001 standards. If you thrive in a detail-oriented, cross-functional environment and are energized by making strong quality systems even better, we encourage you to apply.</p> <p>&nbsp;</p> <p><strong>Opportunities that this position offers you:</strong>&nbsp;</p> <ul> <li><u>Be a leader</u>: Take ownership of the QMS, document control, standardization, and compliance strategies across the entire company. Lead audits with customers and accreditation bodies.</li> <li><u>Expand your toolkit</u>: Develop expertise in audit management, quality systems, compliance, and risk management</li> <li><u>Shape what’s next</u>: Influence quality strategy, system efficiency improvements, and long-term compliance initiatives</li> <li><u>Certify your future</u>: Opportunities for professional certifications such as Quality Auditor, Lean Six Sigma, and more</li> </ul> <p>&nbsp;</p> <p><strong>What you will do at Integral Molecular:</strong>&nbsp;</p> <ul> <li>Own and maintain the QMS (Dot Compliance), including document control, SOP lifecycle, and change control processes</li> <li>Serve as the primary QA representative for internal and external audits, ensuring continuous readiness for ISO 9001 surveillance and recertification</li> <li>Partner with QC personnel across teams to ensure quality standards are applied consistently. Manage quality events from investigation through closure.</li> <li>Track, analyze, and report on QMS performance metrics to identify trends, mitigate risks, and drive continuous improvement initiatives</li> <li>Monitor training compliance and support onboarding and ongoing quality systems training</li> <li>Support vendor qualification activities and coordinate responses to customer quality inquiries, complaints, and audit requests</li> </ul> <p>&nbsp;</p> <p><strong>The ideal candidate will have</strong>:&nbsp;</p> <ul> <li>Working knowledge of ISO 9001 (GMP/GLP experience a plus)</li> <li>Hands-on experience with eQMS platforms (Dot Compliance preferred)</li> <li>Comfort being the primary QA voice in a cross-functional environment, effectively communicating to scientists, auditors, and software vendors</li> <li>BS in a scientific discipline (e.g., biology, biochemistry, chemistry, engineering, mathematics, or related field)</li> <li>1-4 years of experience in Quality Assurance or Quality Systems (biotech, pharma, or related industry preferred)</li> <li>Strong organizational skills and attention to detail</li> <li>Ability to commute in to our offices in University City, with current residence within the Greater Philadelphia area</li> </ul> <p>**We are only accepting local candidates from the Greater Philadelphia area for this role**</p> <p>&nbsp;</p><div class="content-conclusion"><p>&nbsp;</p> <p>Integral Molecular is an Equal Opportunity Employer.</p></div>