QA Specialist

1 week ago

San Francisco, United States Amerit Consulting Full time

Overview:


Our client, a Medical Center facility under the aegis of a California Public Ivy university and one of largest health delivery systems in California, seeks accomplished QA Specialist (Cell Therapy Development).


*** Candidate must be authorized to work in USA without requiring sponsorship ***


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*** Location: 1855 Folsom St, San Francisco, CA 94103

*** Duration: 22 weeks contract to start w/ possibility of extension


Notes:

  • Mon – Fri, 09:00am – 05:00pm Pacific Time.
  • Onsite role.


Description:

  • 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.
  • The Quality Assurance Specialist will, with the guidance of the program Head of QA, perform quality assurance activities.
  • The 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 group does not perform standard-of-care cellular therapy activities, such as hematopoietic stem cell transplants.
  • 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.
  • 50% - 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.
  • 30% - Participates in the development and revision of standard operating procedures and guidelines. Draft and revise Standard Operating Procedures.
  • 10% - 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.
  • 5% - 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.
  • 5% - Additional tasks as assigned to ensure quality in cell therapy development and manufacturing activities.


Qualifications:

  • 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 and 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 the unit.
  • Ability to work in a team-oriented setting, prioritize work, and 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.


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I'd love to talk to you if you think this position is right up your alley, and assure a prompt communication, whichever direction. If you're looking for rewarding employment and a company that puts its employees first, we'd like to work with you.


Satwinder “Sat” Singh

Lead Technical Recruiter


Company Overview:


Amerit Consulting is an extremely fast-growing staffing and consulting firm. Amerit Consulting was founded in 2002 to provide consulting, temporary staffing, direct hire, and payrolling services to Fortune 500 companies nationally; as well as small to mid-sized organizations on a local & regional level. Currently, Amerit has over 2,000 employees in 47 states. We develop and implement solutions that help our clients operate more efficiently, deliver greater customer satisfaction, and see a positive impact on their bottom line. We create value by bringing together the right people to achieve results. Our clients and employees say they choose to work with Amerit because of how we work with them - with service that exceeds their expectations and a personal commitment to their success. Our deep expertise in human capital management has fueled our expansion into direct hire placements, temporary staffing, contract placements, and additional staffing and consulting services that propel our clients’ businesses forward.


Amerit Consulting provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

Applicants, with criminal histories, are considered in a manner that is consistent with local, state, and federal laws.

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