Quality Assurance Specialist in Pharmaceuticals

Join Eurofins Scientific as a Quality Assurance Manager in San Diego, where you will play a crucial role in ensuring the highest standards of quality and compliance in our laboratory operations. In this dynamic position, you will lead a dedicated team, develop and implement quality assurance programs, and foster an environment of continuous improvement.

The Quality Assurance Manager is responsible for overseeing the quality control processes and ensuring that all project deliverables meet established standards and client expectations. This role involves developing and implementing quality assurance strategies, conducting audits, and collaborating with project teams to address quality-related issues.

Join our dynamic team at Turner Townsend as a Quality Assurance/Quality Control Inspector specializing in federal projects. In this role, you will be responsible for ensuring that all aspects of construction comply with established standards and regulations. Your keen eye for detail and commitment to quality will contribute significantly to the success of our projects.

Capricor Therapeutics (NASDAQ: CAPR) is a pioneering biotechnology firm committed to the development of groundbreaking cell and exosome-based therapies aimed at addressing rare diseases. Our flagship innovation, Deramiocel (CAP-1002), is currently in late-stage development for Duchenne muscular dystrophy. Additionally, we leverage our proprietary StealthX™ exosome platform to explore new avenues in targeted delivery systems and vaccinology. Each initiative exemplifies our dedication to expanding the frontiers of science and providing transformative treatments to patients and families in urgent need.The Senior Director of Quality Assurance and Quality Systems will spearhead strategic and operational oversight of all quality initiatives supporting Capricor’s clinical-stage and advancing commercial-stage operations. This role holds comprehensive responsibility for the architecture, implementation, and ongoing enhancement of the Quality Management System (QMS), ensuring adherence to regulatory standards, inspection readiness, and robust quality governance throughout development, manufacturing (including cell therapy production), and the prospective commercialization of Deramiocel and StealthX™-based programs.In this critical position, the Senior Director will collaborate closely with executive leadership, Regulatory Affairs, CMC, Clinical, Manufacturing, and other cross-functional teams to facilitate late-stage development, BLA submissions and responses (including managing all quality-related aspects of the Deramiocel pathway), ensuring commercial readiness, and promoting scalable growth while fostering a proactive, risk-based quality culture throughout the organization.

We are seeking a meticulous Quality Control Reviewer to join our dynamic team in San Diego. In this vital role, you will ensure that all products meet our quality standards and regulatory compliance before they reach our clients. Your keen eye for detail and analytical skills will help us maintain our commitment to excellence.

Turner Townsend is hiring a Senior Construction Manager with a strong focus on Quality Assurance and Quality Control for its San Diego office. This position leads construction projects, ensuring that quality standards and regulatory requirements are met at every stage. Key responsibilities Oversee construction activities to ensure they align with established quality benchmarks and comply with regulations. Collaborate with project stakeholders to support the successful delivery of each project. Encourage a culture of high standards and continuous improvement within project teams. Location This role is based in San Diego.

Ensure adherence to all relevant local and international pharmaceutical regulations.Lead Quality Chemistry, Manufacturing, and Controls (CMC) operations, overseeing batch disposition, manufacturing, packaging, labeling, and testing to guarantee product integrity and timely material release.Provide decisive leadership to enhance quality-related processes including batch disposition, investigations, analytical data reviews, supply chain management, and risk assessment.Act as the primary contact for complex and high-stakes quality challenges and resolutions.Proactively assess and manage quality risks throughout the product lifecycle, recommending and implementing effective mitigation strategies.Collaborate closely with ORIC's technical operations team, Contract Manufacturing Organizations (CMOs), contract testing labs, and distribution centers to ensure rigorous quality reviews of all process and analytical data, supporting informed program decisions.Work synergistically with Regulatory Affairs to facilitate timely and precise submission reviews.Engage actively with clinical program teams, contributing to clinical development meetings to ensure ongoing quality support.Design and implement performance-driven quality metrics and trend analyses to foster continuous improvement.Conduct and present Annual Product Reviews for advanced-stage programs.Lead, mentor, and cultivate a high-performing Quality team, scaling effectively to support transitions from clinical to commercial phases.Serve as Chair or a key member of various governance committees, including ORIC’s Stability Review Board, Material Review Board, and Change Review Board.Represent ORIC Quality in discussions with CDMOs, regulatory authorities, and strategic leadership meetings as required.Exhibit a high degree of adaptability in fast-paced environments, adjusting strategies and priorities according to evolving business needs, technologies, and stakeholder expectations.Develop new functional Standard Operating Procedures (SOPs), policies, and plans for late-phase and commercial readiness as required.

As the Quality Assurance Manager for Good Clinical Practice (GCP) at Sobi, you will play a pivotal role in ensuring the highest standards of quality oversight, assurance, and design within the GCP/GCLP domains. Your responsibilities will include:Overseeing quality assurance and design activities related to GCP/GCLP.Providing guidance and support on GCP/GCLP and GPP-related activities throughout Sobi, including audits, inspections, and risk assessments associated with BLA/NDA/IND/CTA submissions globally.Facilitating the collection of data necessary for the audit program risk assessment.Supporting clinical study-related quality activities across Sobi.Ensuring the qualification of global and local ESP in GCP regulated areas according to Sobi procedures.Collaborating with relevant stakeholders across the Sobi organization.Key Responsibilities:Manage the GCP audit process to ensure excellence throughout the audit lifecycle.Assess and approve GCP deviations and related CAPAs from a quality perspective.Prepare regular status reports on audits, trending deviations, and CAPAs to uphold quality oversight.Contribute to GCP audit risk assessments according to SOPs.Actively engage with cross-functional teams on GxP and Quality requirements, ensuring proper qualification of GCP service providers.Serve as the QA representative during GCP inspections and promote a continuous quality mindset across Sobi.Develop and review GCP QA-related processes under the global framework.

About Capricor Therapeutics Capricor Therapeutics (NASDAQ: CAPR) is a biotechnology company focused on developing cell and exosome-based therapies for rare diseases. The company’s lead product, Deramiocel (CAP-1002), is in late-stage development for Duchenne muscular dystrophy. Capricor’s StealthX™ exosome platform supports new approaches in targeted delivery systems and vaccinology, with a mission to advance science and deliver new treatments for patients and families facing serious conditions. Role Overview: Quality Control Scientist, Analytical Controls This role is based in San Diego (SD1). The Quality Control Scientist, Analytical Controls, develops, qualifies, and manages analytical control materials for QC assays. The scientist will generate and maintain both positive and negative controls, design and execute analytical studies, and troubleshoot or improve analytical methods used in QC testing. Key Responsibilities Develop and qualify analytical control materials for use in QC assays. Manage the lifecycle of control materials, including ongoing maintenance and documentation. Design and conduct analytical studies to support QC operations. Troubleshoot and refine analytical methodologies as needed for QC testing. Ensure reliability, reproducibility, and regulatory compliance of QC assays. Provide scientific guidance on assay control strategies. Collaborate with teams in Quality Control, Analytical Development, Process Development, Manufacturing, and Quality to support analytical readiness for Capricor’s therapeutic programs. Collaboration This position works closely with multiple teams to ensure analytical controls meet the needs of Capricor’s research and manufacturing efforts. The scientist will contribute expertise to cross-functional projects and help maintain high standards for QC laboratory performance.

We are seeking a detail-oriented and analytical Quality Control Chemist to join our dynamic team in San Diego. In this role, you will be responsible for performing a variety of quality control tests and analyses to ensure that our products meet the highest standards of quality and compliance. You will work closely with other departments to develop and implement quality control protocols and contribute to continuous improvement efforts.

Capricor Therapeutics focuses on developing cell and exosome-based therapies for rare diseases. The company’s lead candidate, Deramiocel (CAP-1002), is in late-stage development for Duchenne muscular dystrophy. Capricor also advances its proprietary StealthX™ exosome platform to pursue new possibilities in targeted delivery and vaccinology. Role overview The Senior Director of Quality leads both strategic and operational quality functions for Capricor’s clinical and commercial-stage activities. This position oversees the design, implementation, and continuous improvement of the Quality Management System (QMS). Ensuring regulatory compliance, inspection readiness, and strong quality governance are central to this role, spanning development, manufacturing (including cell therapy production), and the potential commercialization of Deramiocel and StealthX™-based programs. Key responsibilities Provide leadership for all quality-related activities across the organization. Maintain and enhance the QMS to meet regulatory standards and support inspection readiness. Oversee quality governance for development, manufacturing, and commercialization efforts. Support late-stage development, BLA submissions, and responses, with a focus on quality aspects of Deramiocel. Collaboration This role works closely with executive leadership and teams in Regulatory Affairs, CMC, Clinical, and Manufacturing. The Senior Director of Quality helps drive cross-functional efforts for late-stage development and commercial readiness, while promoting a proactive, risk-based quality culture throughout Capricor.

Join our dynamic team at Integrated Resources, Inc. as a Quality Control Biochemist. This role is essential in ensuring the quality and safety of our biochemical products. You will engage in rigorous testing and analysis, contributing to the development of innovative solutions in the biotech industry.

Join Capricor Therapeutics as a Quality Control Associate III specializing in Sample Management. In this vital role, you will ensure the integrity and quality of sample management processes that support our innovative therapies. You will collaborate with cross-functional teams to uphold the highest standards of quality in our laboratory operations.

Oric Pharmaceuticals is seeking a Director of Clinical Quality Assurance to lead our quality assurance efforts. This pivotal role will involve developing and implementing robust quality systems that comply with regulatory standards. As a key player in our clinical operations, you will ensure the integrity of our clinical trials and contribute to the overall success of our drug development programs.

Join our team at Capricor Therapeutics as an Analytical Quality Control Specialist, where you will play a crucial role in ensuring the highest quality standards for our innovative therapeutics. You will engage in analytical testing, data analysis, and quality assessments, contributing to our mission of developing breakthrough treatments. We are looking for a detail-oriented individual who excels in a collaborative environment and is passionate about quality assurance in the pharmaceutical industry.

About Capricor Therapeutics Capricor Therapeutics (NASDAQ: CAPR) is a biotechnology company focused on cell and exosome-based therapies for rare diseases. The company’s lead product, Deramiocel (CAP-1002), is in late-stage development for Duchenne muscular dystrophy. Capricor is also advancing its StealthX™ exosome platform to pursue innovations in targeted delivery and vaccinology. Role Overview: Quality Control Associate II, Controls This position is based in San Diego (SD1). The Quality Control Associate II, Controls, supports the development, qualification, and ongoing management of analytical control materials used in quality control assays. The role ensures QC assays remain reliable and consistent by generating, characterizing, and maintaining both positive and negative controls. What You Will Do Generate and maintain analytical control materials, including positive and negative controls for QC assays. Conduct analytical studies to evaluate assay performance. Assist with troubleshooting and optimizing analytical methods used in quality control testing. Collaborate with QC scientists and cross-functional teams to monitor assay performance and support continuous improvement of analytical methods across Capricor’s therapeutic programs. Impact This role is central to maintaining the accuracy and consistency of QC assays, directly supporting Capricor’s mission to deliver new therapies to patients and families affected by rare diseases.

At Veracyte, we provide thrilling career prospects for individuals eager to join a groundbreaking team dedicated to revolutionizing cancer care for patients worldwide. Being part of Veracyte allows our team members to create a significant impact on the lives of patients, while also fostering personal and professional growth within a mission-driven environment. This embodies what we refer to as the Veracyte way – a collaborative approach guided by our core values, ensuring clinicians have the insights necessary to assist patients in making life-altering decisions.Our Values:We Seek A Better Way: We innovate with courage, learn from our challenges, and remain resilient in our mission to transform cancer care.We Make It Happen: We act swiftly, uphold quality, and infuse enjoyment into our dedicated efforts.We Are Stronger Together: We collaborate transparently, seek understanding, and celebrate our achievements.We Care Deeply: We embrace our diversity, uphold integrity, and support one another.The Position:We are in search of a highly skilled and team-oriented Principal Test Engineer to spearhead the testing processes for applications at Veracyte. This role is critical in our endeavor to expand and develop innovative diagnostic solutions aimed at enhancing patient outcomes and reducing healthcare costs.The Principal Test Engineer is a senior, hands-on quality leader responsible for defining, executing, and continuously refining the software testing strategy within Veracyte's regulated environment. This position guarantees that all software products adhere to relevant quality, safety, and compliance standards while facilitating streamlined delivery processes. The Principal Test Engineer will serve as a subject-matter expert in verification and validation (V&V), test automation, risk-based testing, and regulatory compliance, offering technical guidance to junior testers and working closely with engineering, product, and quality teams.

Join 360 IT Professionals as an Automation Quality Assurance Engineer (SDET) in San Diego, where you'll play a crucial role in enhancing software quality through automated testing. We are seeking a detail-oriented and proactive individual to develop and implement automated tests that ensure the functionality and performance of our software products.

Position Overview:Join our dynamic team as a Quality Control Associate I, where you will engage in both routine and non-routine analysis of incoming products. Utilizing a variety of advanced analyzers and instruments, you will play a key role in supporting the release, characterization, and stability testing of raw materials, production intermediates, and final products.