Job Details
Posted 11 September, 2026
Job Id: 630834
R&D Quality Assurance Specialist
Job Description
Target PR Range: 33-43/hr DOE
JOB DESCRIPTION
SUMMARY/JOB PURPOSE: The R&D Quality Specialist is responsible for providing support to the planning and reporting of GCP/GVP audit activities, including audit preparation, audit closure, audit observation tracking, and records management. As part of continuous improvement initiatives, they will assist in the administration and timely entry of audit reports and related information into the Veeva Quality Vault application. In addition, they will be responsible for ensuring data is migrated to the Veeva audit module.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
* Responsible for maintaining audit-related records throughout the program lifecycle. * Responsible for obtaining and compiling data relevant documents and data in preparation for the conduct of audits
* Assist in maintaining and developing standardized templates based on regulatory requirements and procedures.
* Conduct follow-up activities with internal stakeholders related to the RDQA audit program.
* Input and maintain audit reports in the Veeva Audit Module.
* Assist in tracking and trending of quality metrics related to the RDQA audit program.
SUPERVISORY RESPONSIBILITIES:
* No supervisory responsibilities
EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:
Education:
* BS/B.Sc preferably in the life sciences or STEM disciplines and a minimum of 4 years of related experience in biotech, pharmaceutical, or related industry.
* Also would consider no formal degree with a minimum of 6 years of related experience in biotech, pharmaceutical, or related industry.
Experience:
* Minimum of 4 years experience in biotech, pharmaceutical, or related industry or the equivalent combination of education/training and experience.
* Must have high attention to detail and excellent organizational skills.
* This position requires a basic knowledge and experience with GCP and / or GVP processes related to the conduct of audits.
* Administrative experience in organizing and maintaining audit related records.
* Proven organizational skills to obtain data across multi-functional groups and present results in a consolidated and clear manner.
* Keeps Management informed of status of assigned projects.
Knowledge/Skills:
* Strong written and oral communication skills.
* Excellent attention to detail and organizational skills.
* Highly skilled in the ability to work with ambiguity and complexity and can continuously modify options and solutions across all levels of the organization.
* Strong user of Microsoft Office applications.
WORKING CONDITIONS:
Facilities/Alameda with consideration for remote
* Environment: primarily working in an office setting
* Essential physical requirements; sitting, standing, and typing.
* Physical effort/lifting; light – up to 20 pounds
*CO/NYC candidates might not be considered
Equal Opportunity Employer
We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
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