ADARx Pharmaceuticals Inc. · 2 days ago
Quality Assurance Associate III
San Diego, CA, San Diego, CA, US
Full-time
Onsite
Mid, Senior Level
$95K/yr - $105K/yr
6+ years expADARx Pharmaceuticals Inc. is a late-clinical stage biotechnology company focused on developing life-saving therapeutics. They are seeking a Quality Assurance Associate III to contribute to the development and maintenance of the Quality Management System (QMS) while ensuring compliance with cGxP regulations.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
Assist in the development, implementation, improvement and maintenance of ADARx’s overall Quality Management System (QMS)
Support the implementation of an electronic Quality Management System (eQMS) and act as the administrator to ensure proper configuration and usage of the system. Provide training and support to eQMS users
Provide QA support and oversight to internal staff and suppliers to ensure compliance with SOPs and relevant cGxP requirements
Manage the Document Control process for creating or revising controlled documents following internal procedures
Manage the training program and ensure all GxP related personnel receive appropriate training. Maintain and update training files and training curricula
Support the development of QA-related training materials and provide QA process training to new and existing employees
Author, review, and approve Quality System records, including deviation, CAPA, change records, etc
Author, review, and approve controlled documents for QA and other functional areas
Conduct and support supplier qualification activities, including issuance and review of quality questionnaires, supplier audits, and review of quality agreements
Manage supplier files and the approved supplier list to ensure they are accurate and up-to-date
Support internal audits, including planning, risk assessment, scope, audit program development, fieldwork, reporting and action follow-up
Collect and summarize Key Quality Indicator (KQI) metrics for review to identify trends
Support the preparation and hosting of regulatory inspections and external audits
Proactively identify gaps/risks and propose solutions to support continuous improvement
Qualification
Required
BS/MS degree in a related scientific or technical discipline
6+ years of experience in the biotech/pharmaceutical industry
4+ years of experience in the QA function in a cGxP environment
Strong understanding of cGMP and ICH regulations and guidance
Demonstrated experience in development and implementation of quality processes, procedures and systems
Prior experience using an eQMS is required
Must be able to work independently with supervision as needed
Must be collaborative, work well with other team members in a matrix team environment
Excellent written and verbal communication skills are essential for this role
Strong organizational skills with attention to detail and accuracy
Ability to maintain a high level of confidentiality and exercise discretion
Adaptable / Flexible - willing and able to adjust to multiple demands and shifting priorities as well as an ability to meet day-to-day challenges
Understand project timelines and deliverables and plans/coordinate project work accordingly with departmental, functional, and external stakeholders
Preferred
Previous experience in a GMP QC lab or manufacturing environment preferred
GCP experience a plus
Experience in implementation and/or administration of an eQMS is a plus
Benefits
Equity-based compensation
Performance-based bonuses
401(k) with Company Match
Medical, Dental, Vision
Flexible Spending Account
Life Insurance
Employee Assistance Program
Employee Discounts
Gym Membership
Paid Vacation
Paid Holidays
Paid Sick, Jury Duty, Bereavement
Company
ADARx Pharmaceuticals Inc.
ADARx Pharmaceuticals, Inc., located in San Diego, is a clinical stage biotechnology company committed to turning cutting-edge science into life-saving therapeutics.
51-200 employees
H1B Sponsorship
ADARx Pharmaceuticals Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2023 (1)
Funding
Current Stage
Growth StageTotal Funding
$332MKey Investors
LG Technology VenturesAscenta Capital
2025-02-01Series Unknown
2023-08-09Series C· $200M
2023-01-20Series B· $46M
Leadership Team
Ajim Tamboli
CFO
Robert MacLeod
Chief Scientific Officer
Recent News
ADARx Pharmaceuticals
2025-12-02
ADARx Pharmaceuticals
2025-10-20
Venture Capital Firms
2025-10-10
Company data provided by crunchbase