Senior Quality Assurance Specialist

3 weeks ago


San Jose, United States Kymanox Full time

Description Position at Kymanox Is Kymanox the right fit for you? You want to make a difference and have an impact... You enjoy having an influence in your day to day work... You are motivated by working alongside a team filled with subject matter experts that will help you learn and grow... You wake up every day and do what you do because patients deserve better. If this sounds like you, you've come to the right place.Kymanox is hiring a Senior Quality Assurance Specialist (Contract) on-site with our client in San Jose, California.Primary Responsibilities:Perform investigations per established proceduresSupport problem solving and troubleshooting as part of investigationsGenerate quality records as needed (CAPAs, CCs) to support process improvementsReview laboratory records (test packets, logbooks, etc.) and ensure they have acceptable Good Documentation Practices and are following proceduresUpdate and draft standard operating procedures and work instructionsCommunicate effectively with all team membersMinimum Qualifications:Bachelor's Degree in a scientific, engineering, or other technical discipline7 years of experience in a quality assurance settingDirect experience in record review, investigations, and root cause analysisGood understanding and compliance with principles of Good Documentation PracticesStrong organizational and time management skillsExcellent attention to detailStrong analytical skillsSucceed when working independently and as part of a teamDemonstrated work ethic and accountabilityPreferred Qualifications:Experience working within a quality system (e.g. Veeva)Thrive in a fast paced, growing, and dynamic work environmentAbout Kymanox: Kymanox ('ki-mah-noks'), meaning Ideal Knowledge Transfer, advances life science innovation through insightful solutions and collaboration. We do this by accelerating the design and commercialization of modern medicines for our customers using integrated engineering, scientific, compliance, and project management solutions that are insightful, collaborative, and comprehensive. By building and supporting the development of modern medicines, Kymanox has proven, end-to-end solutions that are helping bring better Life Science Products to the market- and keep it there. We do all of this with heart and pridebecause patients deserve better. Kymanox, founded in 2004, serves clients from Fortune 100 companies to virtual start-up companies all across the globe. Headquartered in Research Triangle Park, NC, we have US offices in Boston and Philadelphia, and since 2022 have expanded to Germany, Switzerland, and Israel.Kymanox is an equal-opportunity employer and works diligently to protect the rights of job seekers by following all local, state, and federal laws as well as best Human Resource (HR) practices in the Life Science industry.



  • San Antonio, United States Extremity Care Full time

    Job DescriptionJob DescriptionSalary: $60,000.00Purpose:The Senior Quality Assurance Specialist is responsible for verifying operational compliance with the quality system and ensuring that all products and quality control processes meet established quality requirements.Duties & Responsibilities: Review HCT/P donor records in accordance with standard...


  • San Jose, United States Medix™ Full time

    Medix is currently hiring for a Quality Specialist to partner with a client through at least the end of the 2024 year! Do you have a background in QA supporting a biotech, med device or pharma manufacturing group? If so, consider applying today. Primary Responsibilities:Perform investigations per established proceduresSupport problem solving and...


  • San Jose, United States Medix™ Full time

    Medix is currently hiring for a Quality Specialist to partner with a client through at least the end of the 2024 year! Do you have a background in QA supporting a biotech, med device or pharma manufacturing group? If so, consider applying today. Primary Responsibilities:Perform investigations per established proceduresSupport problem solving and...


  • San Jose, United States Tik Tok Full time

    About TikTok: TikTok is the leading destination for short-form mobile video. Our mission is to inspire creativity and bring joy. TikTok has global offices including Los Angeles, New York, London, Paris, Berlin, Dubai, Singapore, Jakarta, Seoul and Tokyo. Why Join Us Creation is the core of TikTok's purpose. Our platform is built to help imaginations thrive....


  • San Jose, United States Medix™ Full time

    Primary Responsibilities:- Perform investigations per established procedures- Support problem solving and troubleshooting as part of investigations- Generate quality records as needed (CAPAs, CCs) to support process improvements- Review laboratory records (test packets, logbooks, etc.) and ensure they haveacceptable Good Documentation Practices and are...


  • San Jose, United States Medix™ Full time

    Primary Responsibilities:- Perform investigations per established procedures- Support problem solving and troubleshooting as part of investigations- Generate quality records as needed (CAPAs, CCs) to support process improvements- Review laboratory records (test packets, logbooks, etc.) and ensure they haveacceptable Good Documentation Practices and are...


  • San Francisco, United States Unlayer Full time

    We are Unlayer, a software company on a mission to empower everyone to be creative. We are a global team of awesome people working from over 4 countries around the globe. We hire globally; you work locally - in the heart of San Francisco, a beach outside of São Paulo, or a quiet village near Florence, the choice is yours. Every few months, we travel to meet...


  • San Francisco, United States Unlayer Full time

    We are Unlayer, a software company on a mission to empower everyone to be creative. We are a global team of awesome people working from over 4 countries around the globe. We hire globally; you work locally - in the heart of San Francisco, a beach outside of São Paulo, or a quiet village near Florence, the choice is yours. Every few months, we travel to...


  • San Diego, United States U.S. Pacific Fleet Full time

    **Duties**: - You will plan, develop, organize, administer, evaluate, and manage a comprehensive contract quality assurance program for conforming contractor quality systems conformance to contract requirements. - You will identify and provide contractor availability, quality and management performance assessments to the contracting officer for use in...


  • San Leandro, United States RadNet Full time

    Recommend approval or rejection of potential new suppliers, ingredients, or packaging based on thorough assessments of quality and food safety systems against Ghirardelli policies. Effectively communicate decisions to internal and external parties Manage corrective and preventative actions for Ghirardelli supplier quality-related issues and non-conformances,...


  • San Antonio, United States University Health Full time

    POSITION SUMMARY/RESPONSIBILITIES Provides support for the Health Systems quality improvement functions through the analysis of data and indicators. Responsible for identifying and monitoring ongoing quality improvement issues and opportunities. Assists in the development of process metrics, data collection tools and presentations of resultant data...


  • San Antonio, United States University Health Full time

    POSITION SUMMARY/RESPONSIBILITIES Provides support for the Health Systems quality improvement functions through the analysis of data and indicators. Responsible for identifying and monitoring ongoing quality improvement issues and opportunities. Assists in the development of process metrics, data collection tools and presentations of resultant data...


  • San Francisco, United States Jaguar Health Full time

    Responsible for batch record review and disposition of API and Drug Product lots with reference to approved specifications.Review, revise and maintain standard operational procedures (SOP) and specifications.Review for administration of deviations, out of specification (OOS), and out of trend (OOT) events and participate in preparation of reports.Create and...


  • San Francisco, United States Jaguar Health Full time

    Responsible for batch record review and disposition of API and Drug Product lots with reference to approved specifications.Review, revise and maintain standard operational procedures (SOP) and specifications.Review for administration of deviations, out of specification (OOS), and out of trend (OOT) events and participate in preparation of reports.Create and...


  • San Francisco, United States Jaguar Health Full time

    Responsible for batch record review and disposition of API and Drug Product lots with reference to approved specifications. Review, revise and maintain standard operational procedures (SOP) and specifications. Review for administration of deviations, out of specification (OOS), and out of trend (OOT) events and participate in preparation of reports. Create...


  • San Jose, United States BEPC Incorporated Full time

    IN BEPC INC we are looking for a Quality Engineer. WE WORK ONLY WITH W2 CONTRACTS (NO C2C, OR ANY OTHER RELATED)As a quality engineer you will be responsible for overseeing and implementing quality assurance processes within our organization. You will work closely with cross-functional teams to identify areas for quality improvement, develop quality...


  • San Jose, United States BEPC Inc. - Business Excellence Professional Consulting Full time

    IN BEPC INC we are looking for a Quality Engineer. WE WORK ONLY WITH W2 CONTRACTS (NO C2C, OR ANY OTHER RELATED)As a quality engineer you will be responsible for overseeing and implementing quality assurance processes within our organization. You will work closely with cross-functional teams to identify areas for quality improvement, develop quality...


  • San Jose, United States BEPC Inc. - Business Excellence Professional Consulting Full time

    IN BEPC INC we are looking for a Quality Engineer. WE WORK ONLY WITH W2 CONTRACTS (NO C2C, OR ANY OTHER RELATED)As a quality engineer you will be responsible for overseeing and implementing quality assurance processes within our organization. You will work closely with cross-functional teams to identify areas for quality improvement, develop quality...


  • San Jose, United States BEPC Inc. - Business Excellence Professional Consulting Full time

    IN BEPC INC we are looking for a Quality Engineer. WE WORK ONLY WITH W2 CONTRACTS (NO C2C, OR ANY OTHER RELATED)As a quality engineer you will be responsible for overseeing and implementing quality assurance processes within our organization. You will work closely with cross-functional teams to identify areas for quality improvement, develop quality...


  • San Antonio, Texas, United States Worldwide Clinical Trials - USA Full time

    Who we are We're a global, midsize CRO that pushes boundaries, innovates, and invents because the path to a cure for the world's most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence. We are Worldwide Clinical Trials, and we are a...