Quality Assurance Specialist in Pharmaceuticals

Join our dynamic team at Integrated Resources, Inc. as a Quality Assurance Specialist focused on the pharmaceutical industry. In this role, you will play a crucial part in ensuring the highest quality standards in the development and manufacturing of pharmaceutical products. Your expertise will help maintain compliance with regulatory requirements and enhance product safety and effectiveness.

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.

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.

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.

Join our dynamic team at StemXpert as a Quality Assurance Specialist! In this full-time role, you will play a critical part in ensuring the highest standards of quality in our products. Your keen eye for detail and commitment to excellence will help us maintain our reputation for delivering outstanding solutions to our clients. You will collaborate with cross-functional teams to identify areas for improvement and implement effective testing procedures. If you are passionate about quality assurance and eager to contribute to innovative projects, we would love to hear from you!

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.

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.

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 Title: Quality Assurance Analyst Studio/Department: Quality Assurance Employee Type: Full Time Location: San Diego, CA/Remote (Daybreak Approved Remote Locations: CA, WA, TX, NY) Salary Range: $14.00 - $17.00 per hour, pay may vary based on location. The Quality Assurance Analyst plays a pivotal role in testing various elements of Magic the Gathering Online within the QA Department. Responsibilities include: Developing and implementing test plans for upcoming Card Content and Feature releases Collaborating with fellow analysts and developers to ensure comprehensive testing Validating changes across multiple environments Identifying and testing edge cases beyond expected functionality Championing the player experience by providing qualitative feedback Prioritizing assigned tasks within the QA team Qualifications: Proficient in QA methodologies and best practices Excellent written and verbal communication skills Proactive in raising visibility on issues Minimum of 1 year experience in quality assurance Understanding of Magic the Gathering rules and gameplay A passion for gaming and Quality Assurance is a plus Ability to foster inter-team collaboration to enhance game quality for players Company Culture: Innovative Ownership: Empowering ownership and encouraging creativity We believe in learning from both successes and failures, embracing new ideas, and teaching one another. Our commitment to smart work and passionate craftsmanship drives our team forward. Empathy: Understanding perspectives of team members and players alike We value emotional intelligence, positive behavior, and candid communication, fostering an environment of respect and appreciation. Collaboration: Focusing on the best idea rather than individual recognition We thrive on teamwork, believing that great ideas can originate from anyone.

Join our team as a Quality Assurance Associate, where you'll play a crucial role in ensuring the functionality and reliability of our innovative hiring software. This position involves meticulous testing within Lever's testing environment, which is pivotal for continuous improvement and enhancement of our products.At Lever, we have redefined the talent acquisition landscape, partnering with industry leaders such as Netflix, Shopify, and Cirque du Soleil. Our commitment to fostering a people-first culture and investing in our employees has earned us accolades as one of the best workplaces in the U.S. We are excited to expand our team with dedicated individuals who are passionate about quality and excellence.

Capricor Therapeutics (NASDAQ: CAPR) is an innovative biotechnology firm committed to pioneering cell and exosome-based therapies aimed at treating rare diseases. Our flagship product, Deramiocel (CAP-1002), is currently in late-stage development for Duchenne muscular dystrophy. Additionally, we are leveraging our unique StealthX™ exosome platform to explore new avenues in targeted drug delivery and vaccine development. Every initiative at Capricor embodies our dedication to advancing scientific boundaries and providing transformative therapies for patients and their families.We are looking for a dedicated Quality Assurance Associate II to enhance our team. This pivotal role focuses on scaling our clinical production activities while ensuring adherence to cGMP and regulatory standards. The ideal candidate will assist in batch record reviews, deviation investigations, label issuance, and the management of controlled documents across GLP/GCP/GMP systems. We seek an individual who is detail-oriented, organized, and driven to achieve quality excellence in a dynamic environment.

The Quality Operations Manager plays a pivotal role in facilitating the transition from outdated paper-based processes to a robust and compliant Electronic Quality Management System (eQMS). This position is essential for ensuring that the Quality System effectively supports all phases of drug development, including nonclinical and clinical development, regulatory submissions (IND, NDA/BLA), commercialization, and product lifecycle management.The Quality Operations Manager is tasked with maintaining compliance with relevant GxP requirements (GLP, GCP, GMP), FDA regulations, global standards, and industry best practices. This role also emphasizes readiness for inspections, regulatory submissions, vendor oversight, and the promotion of a quality-centric culture throughout the organization.Key Responsibilities:eQMS Transition:Evaluate current paper-based procedures and devise a comprehensive plan for transitioning to electronic workflows.Ensure data integrity, compliance with Part 11 where necessary, and proper system validation.Facilitate the integration of GxP processes across all functional areas into a cohesive, risk-based framework.Quality System Management:Develop, implement, and uphold procedures for document control, training management, handling deviations and nonconformances, CAPA, change control, risk management, audit management, and complaint handling (if applicable).Coordinate and deliver training on GxP procedures.Support for External Quality Operations: If applicable.Inspection Readiness & Regulatory Interface:Lead inspection readiness initiatives across the organization.Manage regulatory agency inspections (e.g., FDA, EMA, and other global authorities).Oversee the timely and effective development and implementation of CAPAs in response to regulatory findings.Cross-Functional Leadership:Collaborate with Clinical, Regulatory, CMC, Nonclinical, IT, and Commercial teams.Provide training and foster a culture of quality across the organization.Act as a quality advisor to senior leadership.

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.

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.

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.

Join our dynamic team at California Creative Solutions Inc. as a Senior Manager of Data Management in the Pharmaceuticals sector. This full-time role is based in beautiful San Diego and is pivotal in ensuring the integrity and quality of clinical data management for our innovative projects.As a Senior Manager, you will lead the Data Management team, overseeing the design, testing, and implementation of clinical data collection studies. Your expertise will be crucial in managing high-quality data deliverables for regulatory submissions, publications, and due diligence activities in collaboration with Contract Research Organizations (CROs).Key Responsibilities:Collaborate in designing and implementing clinical protocols and data collection systems.Develop and uphold data quality plans.Ensure timely execution of data management timelines for assigned projects.Provide strategic input into protocol designs with a focus on data management.Assist Biostatistics in the evaluation of Statistical Analysis Plans.Identify and resolve data discrepancies using standardized validation systems.Oversee the generation of quality data deliverables for regulatory, publication, and due diligence purposes.Participate in reviewing clinical and regulatory documents to maintain data integrity and quality.Manage projects in collaboration with CROs and lead internal project initiatives.Contribute to the development of standards and process documentation, including SOPs and Work Instructions.Support compliance with industry quality standards and guidelines.Assist in selecting, developing, and evaluating personnel to ensure efficient operations.Engage in the corporate and departmental budget processes and management.Facilitate career development for Data Management personnel.Perform additional duties as required.

Join our dynamic team as a Senior SAS Programmer, where you will play a pivotal role in the pharmaceutical industry, collaborating with talented programmers, biostatisticians, and clinical data managers to collect, analyze, and report clinical data across phase I-IV clinical development programs.Key Responsibilities:Write detailed specifications for SDTM datasets in accordance with the Study Data Tabulation Model (SDTM) Implementation Guide.Develop specifications for analysis datasets guided by statistical analysis plans and the Analysis Data Model (ADaM) Implementation Guide.Create datasets by developing algorithms and writing SAS programs based on the established specifications.Utilize SAS software to produce comprehensive data listings, summary tables, and graphical representations of data.Perform thorough independent checks on data listings, summary tables, and graphs.Facilitate the import and export of SAS data files.Support the data management team in executing data edit checks.Adhere to Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines, 21 CFR Part 11 regulations, internal Standard Operating Procedures (SOPs), and international regulatory requirements.Contribute to project solutions and assist in generalizing these solutions for the Biostatistics group.Engage with project statisticians and provide guidance to fellow programmers involved in project teams.

Acadia Pharmaceuticals is looking for an Executive Assistant to support company leaders in San Diego, California. This position plays a key role in keeping daily operations organized and efficient by handling a variety of administrative duties. What you will do Oversee executive calendars and manage schedules Arrange meetings, including handling logistics and preparing necessary materials Draft reports and prepare documents as requested Work with sensitive information and maintain confidentiality Demonstrate professionalism in every interaction Location This position is based onsite in San Diego, California.