Arena eQMS Administrator - US Tech Solutions, Inc.
South San Francisco, CA 94083
About the Job
Job Title: Arena eQMS Administrator
Location: South San Francisco, CA 94083 and/or Dallas TX 75001 (Hybrid/Onsite)
Duration: 05+ months contract
Job Description:
Responsibilities:
Mandatory Skills:
Education:
Location: South San Francisco, CA 94083 and/or Dallas TX 75001 (Hybrid/Onsite)
Duration: 05+ months contract
Job Description:
- 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.
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.
Mandatory Skills:
- Working knowledge of GxP regulations Strong technical knowledge of GMP and/or GCP regulations and eQMS systems; experience with ArenaPLM administration strongly preferred.
- 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.
Education:
- Associate or Bachelor’s degree in related technical field or equivalent practical experience (3+ years working experience with Associates, 1+ year with Bachelor’s) 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.
Source : US Tech Solutions, Inc.