Quality Assurance Associate III

ADARx Pharmaceuticals Inc.•San Diego, CA

2d•Onsite

About The Position

ADARx is seeking a qualified and highly motivated individual at the QA Associate III level to join the Quality Assurance (QA) group. This is a key role within the QA group and offers exciting opportunity for the successful candidate to make major contributions to the development, implementation and maintenance of the Quality Management System (QMS) at ADARx. This role will collaborate closely with CMC and Clinical functions at ADARx to ensure that quality practices, procedures, standards and systems are established and followed to maintain compliance to applicable cGxP regulations.

Requirements

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.

Nice To Haves

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

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.