Quality Assurance Specialist

1 week ago

san francisco, United States Amerit Consulting Full time

Position: Quality Assurance Specialist

Location: San Francisco, CA 94103

Duration: 22-week contract with a possible extension


Pay Rate: $40/hr - $46/hr (depending on experience)


SUMMARY

  • Involves staffing, administering, or managing research oversight and compliance committee activities related to research activities such as human subjects, animal use and care, conflict of interest, and export control. Reviews research protocols for use in specific fields, assists in writing and reviewing protocols, and compliance with federal, state, and University mandated laws, regulations and policies.


Job Description:

  • The Quality Assurance Specialist will, with the guidance of the program Head of QA, perform quality assurance activities for the Investigational Cellular Therapy Group, HICTF and GMP Facility, and the Pediatric Cellular Therapy Laboratory.
  • These laboratories support a wide range of experimental cellular therapy development and manufacturing activities focusing on regulatory T cells, anti-cancer T cell therapy, CRISPR-Cas9-modified T cell therapies, and human stem cell-based therapies. The focus of the group is on first-in-human phase 1 clinical trials.
  • The position involves working with academic groups at all stages of the cellular therapy development and manufacturing process and with partners and clients in the biopharmaceutical industry that has collaborations or manufacturing activities ongoing with our group.
  • Work is completed in close collaboration with the regulatory affairs, manufacturing, operations, and QC groups.
  • Applies research compliance professional concepts to review protocols to ensure that all regulatory criteria are met, as well as policies and/or regulations from the organization, the state, and systemwide.
  • Routine implementation of quality systems including document management, supplier qualification, record review, report monitoring and tracking, deviation investigation, and other processes per established procedures
  • Participates in the development and revision of standard operating procedures and guidelines.
  • Draft and revise Standard Operating Procedures
  • Communicates directly with investigators to resolve all concerns as identified during the review process.
  • Perform internal audits. Ensure readiness for inspections by the FDA and audits from funders and collaborators.
  • Participates in training individuals and departments on relevant compliance processes, forms, and policies.
  • Coordinate and maintain records of personnel training specific to cell therapy program operations
  • Additional Tasks as assigned to ensure quality in cell therapy development and manufacturing activities.


Job Requirement:

  • Bachelor's degree in related area and / or equivalent experience / training.
  • At least five years’ experience in a quality role in an FDA-regulated industry such as cell therapy, biotechnology, pharmaceuticals, or medical devices.
  • Independence, planning and decision-making abilities to complete assigned duties.
  • Knowledge of relevant Federal and State regulations, and policies.
  • Ability to solve problems, issues; listen, interpret and confirm understanding of others' communications; and be objective.
  • Effective, efficient and tactful oral and written communication skills.
  • Time management skills and the flexibility to accommodate changing priorities in unit.
  • Ability to work in a team oriented setting, to prioritize work, and to follow through on routine assignments with minimal direction.
  • Proficiency with computers, including the ability to operate personal computer software with sophisticated retrieval, storage, and merging capabilities.
  • Strong organizational skills, the ability to multi-task, and work with frequent interruptions.

  • Quality Assurance Specialist

    1 week ago

    San Francisco, California, United States Axelon Full time

    Quality Assurance SpecialistAt Axelon, we are seeking a highly skilled Quality Assurance Specialist to play a critical role in ensuring the highest standards of quality in our Investigational Cellular Therapy Group.Key Responsibilities:Perform quality assurance activities for the Investigational Cellular Therapy Group, ensuring compliance with regulatory...

  • Quality Assurance Specialist

    5 days ago

    San Francisco, California, United States Quality Chemical Laboratories Full time

    Job Summary:Quality Chemical Laboratories (QCL) is a leading pharmaceutical testing and manufacturing laboratory seeking a qualified candidate for the role of Quality Assurance Associate. This key position requires a detail-oriented individual with strong analytical skills to ensure the accuracy and completeness of laboratory reports.Key...

  • Quality Assurance Specialist

    3 days ago

    San Francisco, California, United States Siri InfoSolutions Inc Full time

    Job DescriptionJob Summary: We are seeking a highly skilled Quality Assurance Specialist to join our team at Siri InfoSolutions Inc. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality and compliance of our products and services.Key Responsibilities:Develop and implement quality assurance policies and procedures to ensure...

  • Quality Assurance Specialist

    1 week ago

    San Francisco, California, United States Amerit Consulting Full time

    Job DescriptionJob Summary:Amerit Consulting is seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality and compliance of our cell therapy development and manufacturing activities.Key Responsibilities:Review research protocols to ensure compliance with...

  • Quality Assurance Specialist

    1 day ago

    San Francisco, California, United States The Middlesex Corporation Full time

    About The Middlesex CorporationThe Middlesex Corporation is a leading heavy civil construction company with a strong reputation for delivering high-quality projects. As a Quality Assurance Specialist, you will play a critical role in ensuring the successful implementation of our quality standards and processes across various infrastructure projects.Job...

  • Quality Assurance Specialist

    2 weeks ago

    San Francisco, California, United States Calyx Containers Full time

    Calyx Containers is at the forefront of transforming the cannabis sector by offering cutting-edge packaging and inventory management solutions. Our commitment to sustainability propels our mission to produce over 1 billion eco-conscious products. We are in search of a Quality Assurance Specialist to guarantee that our offerings adhere to the utmost quality...

  • Quality Assurance Specialist

    1 week ago

    San Francisco, United States Amerit Consulting Full time

    Position: Quality Assurance SpecialistLocation: San Francisco, CA 94103Duration: 22-week contract with a possible extension Pay Rate: $40/hr - $46/hr (depending on experience) SUMMARYInvolves staffing, administering, or managing research oversight and compliance committee activities related to research activities such as human subjects, animal use and care,...

  • Product Quality Assurance Specialist

    1 week ago

    San Francisco, California, United States ACME Corporation Full time

    Job OverviewPosition: Quality Assurance SpecialistCompany: ACME CorporationRole Summary: The Quality Assurance Specialist plays a crucial role in maintaining the excellence of our products and services. This position involves rigorous testing of software and systems to uncover any defects, ensuring that our offerings meet the highest standards.Key...

  • MDM Quality Assurance Specialist

    1 week ago

    San Francisco, California, United States IT Vision Group Full time

    Job OverviewPosition: MDM Quality Assurance SpecialistLocation: Bay Area - OnsiteContract Duration: 12 Months+This role focuses on ensuring the integrity and quality of master data across various systems. The ideal candidate will be responsible for:Conducting thorough testing and validation of master data processes.Collaborating with cross-functional teams...

  • Quality Assurance Specialist

    2 days ago

    San Francisco, California, United States GoMacro LLC Full time

    About GoMacro LLCGoMacro LLC is a company that values authenticity, generosity, and compassion for people and the planet. We operate with integrity, create with passion, and conduct ourselves with humility. We seek growth-minded individuals who are inspired by challenges, encouraged by camaraderie, and excited about being leaders at every level.Our...

  • Lead Quality Assurance Specialist

    2 weeks ago

    San Francisco, California, United States Sirona Medical Full time

    About Sirona Medical:At Sirona Medical, we are dedicated to developing innovative tools that empower physicians to operate at the speed of their thoughts. With billions of patient images processed annually, radiologists play a crucial role in healthcare, yet they require more efficient, user-friendly software to enhance their diagnostic capabilities. Our...

  • Senior Quality Assurance Specialist

    1 week ago

    San Francisco, California, United States Hire With Jarvis Full time

    About the RoleWe are seeking a highly skilled Senior Quality Assurance Specialist to join our team at Hire With Jarvis. As a key member of our software development team, you will play a critical role in ensuring the overall quality of our software products.Key ResponsibilitiesDevelop and Execute Quality Assurance StrategiesPlan, develop, and execute...

  • Quality Assurance Specialist

    2 days ago

    San Diego, California, United States Jobot Full time

    Quality Assurance Specialist Needed For Innovative and Growing Space and Optical Engineering CompanyThis Jobot Job is hosted by a reputable staffing agency specializing in placing top talent in the aerospace industry.We are seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for...

  • Quality Assurance Analyst

    1 week ago

    San Francisco, California, United States ACME Corporation Full time

    Job OverviewPosition: Quality Assurance SpecialistCompany: ACME CorporationRole Summary:The Quality Assurance Specialist plays a crucial role in maintaining the integrity and excellence of our products and services. This position involves a systematic approach to testing software and systems, ensuring that any defects are identified and addressed...

  • Quality Assurance Specialist

    2 days ago

    San Diego, California, United States Aerotek Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Specialist to join our team at Aerotek. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of our products and services, and for identifying and implementing process improvements to enhance our overall quality management system.Key ResponsibilitiesInspection and...

  • Quality Assurance Specialist

    1 week ago

    San Antonio, Texas, United States VIP Staffing Full time

    About VIP Staffing VIP Staffing is a leading provider of staffing solutions, connecting top talent with exceptional organizations across various industries. We are committed to building long-term relationships based on trust, integrity, and mutual success. Quality Assurance Specialist We are seeking a detail-oriented and experienced Quality Assurance...

  • Quality Assurance Specialist

    3 days ago

    San Marcos, California, United States Tri-Starr Talent Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Specialist to join our team at Tri-Starr Talent. As a Quality Assurance Specialist, you will be responsible for ensuring the quality and durability of precast concrete products.Key ResponsibilitiesInspection and TestingConduct routine inspections of raw materials, in-process production, and...

  • Quality Assurance Specialist

    6 hours ago

    San Jose, California, United States Sanmina Full time

    Job Summary:Sanmina Corporation, a leading integrated manufacturing solutions provider, seeks a skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality of our products and services.Key Responsibilities:Perform product inspection and/or audits of quality control programs...

  • Quality Assurance Specialist

    6 days ago

    San Diego, California, United States Oura Full time

    Join Our Team at OuraAt Oura, we are committed to helping individuals unlock their full potential through innovative technology. Our flagship product, the Oura Ring, offers profound insights into health and wellness, enabling users globally to lead healthier lifestyles.We are on the lookout for a skilled Quality Assurance Specialist to become a vital member...

  • Quality Assurance Specialist

    2 weeks ago

    San Francisco, California, United States TEKsystems Full time

    Job OverviewCompany Sector: E-commerceContract Duration: 12 MonthsWork Arrangement: On-Site (4 days a week) Essential SkillsProficient in testing across various browsers and devicesMeticulous attention to detailExperience in eCommerce testing with a customer-centric approachSelf-starter with the ability to conduct independent researchPosition SummaryThe...