Arena eQMS Administrator

US Tech Solutions • South San Francisco, CA

4d

About The Position

Client is seeking a highly skilled and experienced eQMS Administrator who will play a crucial role in establishing new eQMS software to support digital health application and medical device product development. Individual will ensure compliance with industry regulations and standards, playing a key role in the implementation, maintenance, and retirement of eQMS software.

Requirements

• Working knowledge of GxP regulations
• Strong technical knowledge of GMP and/or GCP regulations and eQMS systems
• 4+ years of work experience, preferably in a regulated industry, e.g., medical device, pharmaceutical under good clinical, laboratory, manufacturing, and distribution practice (GxP) environments.

Nice To Haves

• Comfortable with Google Apps for Work applications.
• Proven ability to handle ambiguity and work collaboratively with internal and external cross-functional teams.
• General experience with user acceptance testing in medical device/pharmaceutical environments.

Responsibilities

• Work closely with the Quality team to execute user acceptance test cases for validation of new eQMS software.
• Responsible for administrative controls, system configurations, periodic system upgrades, and continuous improvement efforts of the eQMS, as needed.
• Work with software vendors and internal cross functional teams to ensure systems are appropriately validated, implemented, and maintained in accordance with current industry practices.
• Provide CAPA, audit, and overall QMS support in regard to software.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree