Kelly Services Sr. CQA Specialist in Emeryville, California
Sr. CQA Specialist
Provide input and oversight to ensure all documentation, processes and systems meet our compliance requirements and are effectively monitored and maintained.
You will use your expertise in FDAs ( 21 CFR parts 11, 50, 54, 56 & 312) and global compliance standards ( ICH- E6 R1 & R2, ICH E2A, E3, & E8 ) to ensure compliance across and interpret the requirements to Clinical-Ops , Data management , RA Quality Assurance and Safety/PV department .
In this role, you’ll plan requirements, identify risks, manage schedules, and communicate clearly with all project and clinical stakeholders. You will report under the Quality organization.
Identify, assess, and advise on compliance risks and controls to a variety of stakeholders and customers.
Design Clinical QA folders for all development studies that is easy to navigate and identify.
Locate current and archive files from Quality documentation system (VQD-Veeva vault) and file into new filing system.
Work on CQA GCP deficient quality documents and resolve outstanding challenges.
Create and drive programs to tighten the data security and governance over our internal data.
Coordinate, manage, and facilitate compliance processes to provide timely deliverables. Assist in the development, implementation, and maintenance of GCP Quality Systems and SOPs
Review and approve clinical documents (protocols, ICFs, Monitoring plans, Blind mgmt. plan & eCRF, UATs, etc.)
Train and mentor Clinical-ops staff on global GCP regulations and Guidelines
Assist on CAPA follow-ups on in-house and clinical site CAPs.
Author Clinical Quality plans for the studies.
Perform audit of Clinical study reports.
Support in Clinical Site holds and for-cause audits.
Actively participate in Clinical Operations/Data management meetings and provide timely updates to the department lead.
Conduct CROs, Reading labs. Central labs and Investigator site audits
Participate in FDA PAI mock inspection audits.
Identify Quality and Compliance related issues and implement practical solutions while ensuring timelines are maintained.
Conduct QA oversight and audit of eTMFs
Assist in the preparation, execution and follow up activities related to internal and external regulatory audits, and inspections.
Prepare and conduct external vendor inspections and audits and maintain the schedule or required audits to maintain compliance.
Analyzes deviations between SOPs and observed actions and determines if the actions must be corrected or the SOPs must be modified.
Creates and updates Standard Operating Procedures (SOP). Provide training and overall guidance to on the clinical affairs organization on compliance requirements.
Demonstrate high level of involvement in continuous improvement of quality assurance philosophy and practices to ensure the highest standards are maintained.
Previous experience with regulated global trials preferred. Current and working knowledge interpretation/implementation of government and other local state/government regulations/requirements governing the ability to work in a clinical setting required.
Proven ability to manage multiple projects while maintaining quality.
Strong interpersonal skills with reputation for collaboration with colleagues.
Strong computer skills including MS Office (Word, Excel, PowerPoint, MS Project).
Demonstrated success in assisting in solving complex strategies across multiple functions within the department in support of conducting multiple global clinical trials across multiple franchises required.
Demonstrated understanding of laws, regulations, standards, and guidance governing the conduct of clinical studies, as well as preparation of clinical documentation in support of regulatory submissions required.
Proactive, energetic, Analytical, strategic thinker, self-assured professional with high personal integrity and ability to develop good interpersonal relationships with stakeholders.
Essential Duties and Responsibilities:
Support continuous improvement of quality processes and systems that assure compliance of clinical study-related activities, and in collaboration with contract research organizations and in-house clinical development.
Design Clinical QA folders for all development studies that is easy to navigate and identify. Locate current and archive files from Quality documentation system (VQD-Veeva vault) and file into new filing system. Maintained Clinical Quality documentation.
Support preparations for and follow-up of effective audits of investigator sites, essential documents (Protocol, IB, Master Template Inform Consent, CSR), Trial Master Files, vendors, and internal processes.
Provide effective oversight of systems cross-functionally in clinical research and development in collaboration with matrix team members (attend internal Study Team Meetings and corresponding external study meetings)
Ability to identify, evaluate, and communicate risks to Clinical Quality Assurance processes and/or systems with recommendations for resolution
Support training staff and external partners in compliance, current clinical practices and procedures
Maintained annual Internal audit schedule and external Audit Schedule into Annual audit plan. Manages corresponding workflows ensures documentation is maintained per procedures. Assist in vendor audits and CAPA follow-ups and closure.
Promote collaboration internally and with external partners to ensure all systems, processes, and their outcomes comply with applicable international and national standards, regulations, and guidelines.
Support GCP inspection readiness & Provide in-house GCP training.
Bachelor’s degree in a scientific field preferred 6+ years of experience in Clinical Quality Assurance, Quality Assurance or Clinical Operations Role (Pharmaceuticals or Biotechnology).
Broad knowledge of risk-based quality systems approaches consistent with ICH E-6(R1 &R2) for Good Clinical Practice. Experience with all phases of clinical trials
Knowledge of Good Clinical Practices (FDA and ICH), a solid understanding of 21 CFR Part 11, 50,54,56, & 312 with respect to clinical systems, including database, eCRF validation procedures, eCTD Quality Assurance, and eTMF requirements
Ability to identify and/or resolve quality issues/discrepancies with others in a proactive, diplomatic, flexible and constructive manner.
Attention to detail as well as a crisp, clear and concise style in written and oral communications.
Demonstrated ability to work independently and flexibly in a fast-paced, high growth environment
Experience supporting inspection-readiness activities (FDA, HC & EMA) is a plus.
Why Kelly ® ?
Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.
About Kelly ®
At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.
Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)